Look at this everybody. We did it 2022 tops Star Wars It's chrome black edition. So at top top chrome black Star Wars 12 box random character break number one It's our last Jersey fest break.  So I've been looking forward to this all week long So thanks everybody now one spot gets you for on this list Now keep in mind if you get a care if you get an actor Right that list the list of actor names. They're only for the autographs Because there's one spot that'll get all non-autoed cards or all other cards not on the list, which means numbered cards So if there's an atom driver one-of-one that goes to the all non-auto spot If it's an atom driver autograph that'll go to the atom driver spot So there is actually a lot of great value in this sort of this a non-auto list right here I think I think everyone read no no one had any questions for me about it So I'm assuming everyone has read the item description and has understood the parameters of this break So with that being said, there are the 20 right here And there's there's the whole list right here. That's a list of 80 So I'm just I want to do this here on the spreadsheet. So I make sure that I Get the numbers correctly. There we go. So there's your 80 right there. That's gonna go into a list Thanks to the people who bought their spots right up as always and congrats again to the people who won their spots Nice draw for Alan and now let's gather the list of names here and put them into this list And then we'll put the randomizer results right here. Let's roll it and randomize it two and a six eight times for names and names and actors one two three four five six seven and Eighth and final time. I got Michael all the way down to Andy now. I also realized that All their cars not listed that could be autos too. So let's say I mean all the main all the main people We got let's say there's like I don't know we missed a name on the checklist or it was like some Random voice actor from like Star Wars resistance or something like that Then you know and it's an autograph of that voice actor and have it doesn't be isn't on this list We'll obviously go to that section right there as well two and a six eight times for this list one two three four five six seven and Eighth and final time. I Wish it was I wish with the dice roll was six So I could be like order 66 or like a six and a six. It was like 12 Order 66 Do it All right, so I'm just gonna show you the list as is now and Then I'll alphabetize by your first names and I'll even pause the video So you get a chance to digest the characters that you got Digest it like a sarlacc all right Nice Chris with the all non-auto or all other cars not listed spot Chris with Billy D willing Lando system Lando's not a system You're dumb. All right, so there's everybody right there All right now let's sort by your first names So Alan Matsui there are your group of characters right there Alan Murdock with the spots you bought straight up and look at all the these guys that you got from the spots that you want It's pretty nice 80 owns Then they go by system. That's a nice draw for you there Chris the all non-auto spot Rosario Dawson carry Fisher Amelia Clark and You got this right here. Oh Yeah, okay. Yeah, you got all Billy D. Williams D Bradley Baker somebody else. That's Alan All right, and last but mojo these guys right here Carl Weathers nice Carl Weathers also Not only is he in the man Lorian. He's also in and you know, Rocky, but he's also in Arrested development Craig with the Nally Portman spot Obi-Wan Was hoping you'd get a one of the Obi-Wan characters, but no He's got Hayden Christensen Jim Cummings to Matt Bristow Michael Matt Bristow Riz Ahmed and he said Amy Sedaris Even Dermot nice young Carla Esposito right there Daisy Ridley from Michael Paul Bettany Samuel L. Jackson Felicity Jones Lars Michelson Alden Aaron Reich and Then Tim Harrison Ford spot right there too Freddie Pratt and sooner He was the voice actor for Canaan Jarris and the Star Wars rebel series, which I Which I really recommend All right, so there you go gang I'm gonna pause the video just for a little bit if you're watching live and you want to see your your characters again Definitely, let me know we'll have room for that. We'll have time for that as well stick around everybody We'll be right back. All right, everybody. No deals were done So it's case breaking time Do All right, so a lot like tops chrome black baseball that you've seen one in case autograph and then some extra cards in there All right, so this goes to the all other spot All right, it's a trap That's to 199 I Feel like there would be a copyright strike on the video Nancy I would love to play the Star Wars theme in the background. I'll just have to provide it That's Hondo Onaka It's Jim Cunning's as Honda Onaka great character in Star Wars rebels and That will go to Juan with that one. He's a fun character Alright Joe Pizzol, you don't know who Jim Cummings is Come on man. I mean he has appeared in almost 400 roles the official voice of Winnie the Pooh since 1988 Tigger since 1989 Tasmanian devil since 1991 Come on man. There's the Grand Inquisitor. These guys we saw in Star Wars rebels Harris and Dula also in Star Wars novels. I think a lot of the Star Wars rebels characters are gonna be in the Ahsoka series in 2023 So, you know, maybe a good primer primer primer going into Osaka the Ahsoka series that is Next in 2023 this break brought to you by Disney Plus Subscribe to Disney Plus today Using the code Jaspie and get 0% off. All right Next up is Nambi Gima. It's Kirin Shah. That was the if you saw the Mandalorian That was the The alien with the with the the eggs that baby Yoda was eating Alan Matsui With Kirin Shah Oh, we're about to get sued All right, there's Pelle Motto Poe Dameron and C3 Pio even Joe Pizzle has to know this guy 73 out of 99. All of these are going to Chris Chris D and that Not auto spot. All right next up is Is Dryden Voss? Paul Bettany Dryden Voss was the villain in the Han Solo picture Which if you watch if you do a rewatch of Han Solo the the standalone movie Try to divide up this the sequences as as episodes and It probably would have worked a lot better as a TV show and Paul Bettany, of course vision as well and What else was he and he was what was that movie with a master and commander Nicholas Stofell with the Paul Bettany With Russell Crowe master and commander that seafaring movie That was a good one But also was he and he was in another movie with Russell Crowe and yes, and and his wife Jennifer Connelly.  All right. Next up is nice Sabine Ren and that's Tia Sarkar as Sabine Ren I think she'll she was she's gonna mean the live-action Ahsoka as well. Yeah, they're gonna really lean into a lot of the They're gonna really lean into a lot of Star Wars rebel stuff Which I'm excited about a lot of loose ends that weren't really tied up there Alan Murdoch With that one, you know what though Rex they tell us to cease we desist like Whatever I do love the undercover boss Kylo Ren sketches on SNL those are pretty good An Adam Driver hosted We got Captain Phasma. They didn't do enough with her in the in the in the prequels There's Darth Maul To 199 and Mace Windu Chris Chris Jaspie. What's your favorite Mace Windu quote? This party is over That's a good one Next up is Looks like we've got some orange parallel here. It's Peli Motto. That's Amy Cideris to 25 nice Did not expect Amy Cideris to end up in a Star Wars property, but there she is Amy Cideris going to Matt Bristow All right, we got Omega or Omega. I think she has a New Zealand accent Omega Rekka right and she says Rekker in the bad batch Rekka Rekka There's Koska Reeves to 199 and Moff Gideon with the darksaber Oh, he sure did you are on the council, but we do not grant you the rank of master and then And then Anakin Skywalker just goes what the f That's just that's just bad management That's just bad management Chris Jaspie. It's like having I don't know one of the best players on your team Not making him captain or at least vice captain. I mean you're wrecking the locker room right there All right Next up is Rick Oli Ralph Brown I I don't have anything Chris. Who do you who do you have for this guy? And uh, that is Ralph Brown I'm not gonna know all these folks here Juan Escobie Pena with that. Oh, he was one of the uh It's one of the starship captains On Naboo He was in phantom menace. All right Oh, also Mike tower your questions about the empire and memos and notes They definitely have I mean it's the empire is a massive bureaucracy You know Palpatine's busy trying to like I don't know take over the world. Even though he already hasn't taken over the rest of it's just bureaucracy there's Quinlan Voss Han Solo and Rose Tico to 199 All right. Next up is Hunter From a bad batch. That's D Bradley Baker as hunter 92 out of 99 D Bradley Baker big spot for him all the D Bradley Bakers Going to Alan Murdock D Bradley break Baker has done a ton of stuff with with uh with his life lot of cartoons a lot of voiceovers Uh, he does this is he does uh, I thought he did something with r2d2 But I maybe not Think of someone else then But he does the voice of uh Klaus in american debt All right next box Gilo's wondering it's 2022. How do we not have lightsabers yet? I mean Yeah, how do we not have lightsabers yet? All right. We got low bot And then he's like Ah, there's Nala say 118 out of 199. Hello master Jedi Yes, we have the whole clone order ready for you Right this way And then and you and McGregor is like, well, I didn't order any clones. What are you talking about? Crazy long neck. All right. Next one is Aurora Singh Jamie King eight out of 25 A uh bounty bounty hunter, I think Uh, Jamie King goes to Alan Murdoch Animated series. I haven't seen resistance But Star Wars rebel clone wars is great Star Wars rebels for sure is is a There's a really underrated one. Does Darth Vader have sleep apnea? I don't know. I feel like his breathing apparatus helps helps him with that But I think he's got a lot of other problems to worry about Let's see. Yeah. Do we sound like stewie stewie? I was trying to do the voice of that Kaminen lady. There's Ezra Briser Bridger Asajj Ventress She's a great character. And we got Lama Sue also from five out of five The prime minister of Kamino There's some shady shady peeps On Kamino ladies and gentlemen, this goes to the all non-auto card spot And that's for Chris to tell Chris All aboard the big hit express Next up is Admiral Ackbar. It's a trap Tim Rose is Admiral Ackbar It's a trap. I'm sure many of you've seen the meme or the movie Chris to tell Chris D with D Tim Rose Three more bad Star Wars impressions to go There's Django Fett There's the Mandalorian Baby Yoda This is the way And Finn 90 out of uh 99 FN 2187 FN 2187 I'm gonna call you Finn Can someone tell by the top of this character's head? It is Margrave Juro I don't I don't know this person. I have nothing for this person. Uh, that's Andrew Cachino Nancy with that one. Sorry Nancy. I've got nothing for this guy Um Oh, because he was in the Star Wars visions shorts. I don't I've not seen that I think that's where they got a bunch of the biggest Animation studios in Japan to do retellings of Star Wars stories I haven't seen doesn't that make mandolin a baby Yoda sitter? Yeah, you tell him that Mike tower see see the kind of reaction you get from the Mandalorian. I would dare not do that Thanks Derek Yeah, more like his pop There's a bush and she's got a thermal new nuclear detonator right those carry from this leia underneath there There's a so katana. That's gonna be a great series 2023 subscribe Disney plus this break sponsored by Disney plus and grogu 47 out of 75. This is the way Oh, and then the encased Can't forget about that. That's the main hit It is It is Ronzer Malk That's mark boon jr. As Ronzer Malk Malk who was in in the Mandalorian And that's for alan alan matsui with that one Yeah, he was on that that the the roost space station Believe that's where they ran into bill burr. All right final box I wasn't gonna do lightsaber noises for every box, but I thought that would get uh That they'd get annoying after a while All right, there's kane and jarris that he is voiced by freddy prince jr His wife sarah michelle galler is also a voice in the star wars rebel shows. There's t Uh k2so one of my favorite droids and there's lando Such a cool guy. Yeah, what a what a cool guy He's the only guy in the universe that calls han solo han Yeah, I know right It's like Full sabak right there for lando calories and that goes to the all the other spot Absolutely mike tower han solo and carbonite is considered to be encased All right last one It's gonna be Bale organa. It's phil lemar as bale organa cartoon bale organa not jimmy smith's who's uh Who's real life bale organa He's near old to me. Uh tim Oh, is he in some of it? I don't realize that They were gonna fill them are all those uh voice actors It's worth looking up because you'll be surprised at what animated shows or what other voiceover work That they've that they've done. All right. Thanks everybody jersey fest randomizer time So as I said, we're gonna use the original 20 names right here And a name on top gets the last spot in the jersey fest after five into two seven times. Good luck everybody one two three four five six and And seventh and final time it's gonna be Stephen k Congrats to you. I don't know if I called your number too often in this break, but You got the last jersey uh fest spot.


Greetings and welcome to the Introduction to Astronomy. In this lecture, we are going to talk about climate change and look at how Earth has changed over the billions of years it has been around. So, let's go ahead. We talked previously about the atmosphere. Let's look a little bit about some of those changes. So, what kind of changes do we get to the Earth's atmosphere? Well, there are two types. We can have natural changes and we can have man-made changes. And both of these do occur. We have volcanic activity does spew material into the atmosphere, changing it and, in fact, how our atmosphere changed from that original composition to what it has currently. Life, just by existing, has created oxygen in the atmosphere. And, of course, we have man-made things like pollution and greenhouse gases, which also affect our atmosphere. Now, one of the important things to talk about here is the greenhouse effect. So, the greenhouse effect, in the greenhouse effect, sunlight passes through Earth's atmosphere and heats the ground. So, the surface will heat, the atmosphere will heat, and the Earth will radiate that temperature away. Now, sunlight comes in in the visible part of the spectrum, which penetrates the atmosphere. The Earth radiates infrared light because it is a lower temperature. Remember from previous lectures how a black body works. It absorbs all of the radiation coming in, and it emits radiation depending only on its temperature. Since the Earth is cool, it emits infrared. And some of this infrared is then trapped by gases in the atmosphere. We know of carbon dioxide, water, methane, and others. So, depending on exactly what is here, the sunlight comes in. Even some sunlight will get through the clouds, and then the surface radiates that, which traps the heat in there. Some sunlight is reflected away, depending on the amount of cloud cover. And we can notice this through the greenhouse effect on the morning. Sorry, in the morning. So, if you get up in the morning early and it's really cold outside and you look up, you'll probably see that it's nice and clear. And that's because there were no clouds which have water vapor, which is an extremely efficient greenhouse gas to trap in the heat. When you wake up on that hot, stuffy morning where it's very warm, then you can look up and it's usually cloudy. And that's because the clouds are there keeping that extra heat in and keeping Earth warmer. So, what about the greenhouse effect? Well, is it a bad thing? Actually, not really. It warms the Earth by about 30 degrees Celsius or 86 degrees Fahrenheit. So, think of what our temperatures would be like without that. It would rarely get above freezing and life would not be possible. Everything would be frozen, except maybe the equatorial regions would be completely frozen. And we do see the greenhouse effect occurring on other planets as well when we talk about Venus we will see where the greenhouse effect can run away. So, what is the problem when we talk about climate change? Well, measurements show that the Earth has warmed about one degree Celsius over 150 years. Now, while that may not sound like a lot, it is a pretty big increase for just 150 years. Now, the question is, what is causing this increase? Is it something natural? As we've talked about previously, the Earth does change. So, the temperatures and properties of the Earth are not always the same. Is it man-made? Is it through things that we have done? Or is it some combination of the two? And here we see the graph showing from 1880 temperatures and how they have increased really pretty drastically, especially over the last few decades. So, temperatures have increased quite a bit there. So, what do we believe is happening here? Well, what is the consensus? First of all, what does a consensus mean? Well, it's the general agreement that this is the current best explanation for something. That does change. A consensus can change. So, just to be fair, a scientific consensus was once that Earth was the center of the universe. There was a point where you could have figured out that, you know, 99% of the scientists would have said the Earth was the center of the universe, and everything moves around it. So, with new evidence, things do change. But the consensus is that this, the best explanation is that the man-made causes are dominant here. So, we have carbon dioxide emission from fossil fuels. We have methane emission from livestock. So, what do we mean when we look at a model of this? What do the models show? Well, most models predict a couple of degrees rise over the next hundred years. The question is how accurate are these models? Remember that a model is a simplification of the real world. We can't model the Earth precisely. It's just not possible to model such a complex system. So, any models do have to make simplifications and assumptions. And we can't tell you how accurate they are because they're based on future predictions. If we could wait a couple hundred years and see what happens, then we could judge how accurate the models were. But the Earth's atmosphere is very complex. So, this is not something like predicting an eclipse. We can tell you when the next eclipse will occur, and we can tell you hundreds of years from now when eclipses will occur down to the second as to when they will start and end. We cannot tell you with the same accuracy, even close to that, what the average temperature of Earth will be a hundred years from now. So, is this a hoax? Sometimes you hear that there is a hoax, and that's really doubtful. Certainly scientists do have biases, like everyone else, where we see what we want to see. If something agrees with our beliefs, then we tend to agree with that, we tend to assume that, and if it doesn't, then we tend to look for other explanations. And the scientists can only go by the data that they have. So, how accurate are these measurements? Well, that's a good question, and observations have changed over those 150 years. Certainly, technology has improved, and we have better ways of measuring the temperatures now than we did 150 years ago. So, how do these measurements compare to those made in the 1800s? What adjustments have been made to the data? Now, there's nothing wrong with making adjustments to the data. You tend to do this, you'll make calibrations, and you may have to adjust the data, and that is a perfectly legitimate part of science. However, that does have to be clear as to what adjustments are being made, and the original data should always be available, because maybe those adjustments were off, and maybe you have to readjust, and it may find that things were not as bad as we thought, or it may find that things are worse than we thought. So, the original data, it is always important to have that original data there. Now, how does this tie into politics?  We get things where people are called deniers of climate change. Well, there's a difference between being called a denier or a skeptic. So, what we're looking at, these two things can be in the same person, and they can have very different connotations. A denier is something we talk about denying science. And could you be a skeptic that just says that you are making questions about something, but not actually denying it? So, to be fair, it's not a bad thing to be skeptical in science. We should question everything and challenge all of these models, and push them to be the best that they can be. Obviously, we don't also want to deny obvious facts. So, we've talked previously about, you know, whether the earth is round or not. Well, that has now been proven very well. So, there are some things that are very, very well established, and there are other things that are still in process, and we are still trying to better understand them. But to be fair again, someone who expressed reservations about the climate studies is not necessarily denying science. Now, don't get me wrong, there are people who are denying science who are deniers of climate change. But there are also those who are skeptical and could be considered trying to push this to better understand. And those would be people who are open to changing on either side, based on new data. So, the whole idea is to push things to their limit. What about petroleum? Well, a lot of the climate change is based on carbon emissions, and that is because of petroleum. How much is left? Well, depending on when you look at it, if you go back to books from 30, 40 years ago, it said we would run out by now, and of course we found more. But there is a limited resource. So, we will likely uncover new petroleum resources, but can we go for another 50, 100, or 200-year supply? Eventually, no matter what it is, even if it's 500 years, eventually those supplies will run out and new energy sources are needed. There is simply no way that petroleum can replenish itself, and we will eventually run out of ways to be able to get this. So, we also use petroleum in other ways than just energy. The other thing is that we will not find any resources of this in the solar system other than on Earth. You can imagine, perhaps, finding other sources of energy. Solar energy would be one, nuclear energy would be another. It's quite possible that you could find deposits of things like uranium elsewhere in the solar system. However, petroleum is confined to Earth being a fossil fuel, and Earth being the only planet that has had life. So, what do we do when we think about climate change? Well, be skeptical. Always skeptical, but not just in general, but skeptical towards both sides. Make sure that they can convince you as to what they are saying. So, you always want to look at the scientific side. When you start talking emotional, that gets out of the topic of science. So, when it starts to get overly emotional or appealing to your emotional side, again, regardless of what side is doing this, it is not a... You're getting out of the science. The science really needs to take the emotions out of it. That's when you're putting it into politics. And it's not necessarily that it's bad, it's just not science. So, when you're getting to the emotional, that may appeal to how you want to handle things in a political debate. But when we're looking at the scientific side, we want to look at the basic facts and understand how the studies are done and what modifications have been made and what the models are showing and what the variations are in the models. Again, we also want to look at the background of the person. You might want to give more credit to a scientist than a politician or an actor. What are their interests? If they're working in the oil industry? Again, they may have a bias toward not thinking that climate change is man-made. What if they're working in alternative fuels? Well, they may have the opposite bias. So, it is a good idea to look at the background. Even if it is a scientist, we have to look at their interests. And it's not necessary that they are purposefully doing this. But again, there are always things that bias us internally. Sometimes we don't even notice these. Overall, again, think and reason for yourself. Don't just accept things blindly, but don't just reject things blindly or emotionally either. So, let's go ahead and finish up with our summary. And what we've looked at is, yes, the Earth's atmosphere and climate have changed in the past and will change in the future regardless of what we do. The greenhouse effect has warmed Earth, making life possible here. Now, we've seen that over the past 150 years, temperatures have risen. And again, the question is, how much of it is man-made? And there's a big difference as to what we can do depending on how much. So, I specified before, is there a man-made climate change? Well, there's probably some combination. Maybe we're responsible some and maybe some is natural. And the question as to how much we can do depends on where that percentage lies. If we are 90% responsible, which is the current consensus, then we could probably do a lot to affect this. If we are 10% responsible, there's probably a lot less that we can do that will actually be able to change anything here. So that concludes this lecture on climate change. We'll be back again next time for another topic in astronomy. So until then, have a great day, everyone. And I will see you in class.


Does real magic exist or does it not exist? Some people they're skeptical, they say real magic does not exist. It's all fake. It's all illusions and deceit. Some people they will tell you know it does exist. I've seen someone do this. I've seen a magician do that. My father told me this. I heard a story from here or there and they believe that there is true magic. So this is an area of controversy. And likewise, when you go and ask the ulama themselves, do you believe in magic? Is there magic or it's all fake? You'll find also disagreements. I have asked some ulama personally they say it's all fake. I have asked other ulama they say no there is real magic. Yes it's rare but there is real magic. And they will relate to you some stories of true magic. For example, I once asked one of the ulama about magic. Does it exist or is it all fake? It's all a myth. It's all using deceit. It's all using illusions. This alim told me no of course there is magic. And he told me two stories about magic from his father. He says my father was also alim 50, 60 years ago. He went to India and as you know, India is known as the country of all the mysteries and the crazy things and the magicians. So his father went to India and he says he met an Indian magician and he says in front of me he would take the pits of the date, the seed of the date. He would put it in his mouth and he would take it out and it was true gold. And he said my father, he went and he made sure that it wasn't a game. It wasn't any form of deceit. It wasn't any illusion. He saw that it was actually gold. He was taking the seed of the date and turning it into gold. Now is this true or not? Allah knows. But this view does exist. Or another story that he related of magic, true magic, he says that in the city of Najaf there was a magician also 50, 60 years ago. And this magician was believed to hold superpowers. And one day there was a problem between two people. One person had a big, big problem with another person. So one of them he wanted to kill the other person but he didn't want to do it in a natural way. You get caught. He wanted to do it through magic. So he went to that magician and he asked him for help. He said I want a recipe. I want to spell a chant in order for this person to die. And this magician, according to this alem, he says that this magician gave him the recipe. It was a very strange, bizarre recipe. He told him I do have a way in which this person will die in a mysterious way. But there is a recipe. What is it? He said you have to go and find a certain animal. I forgot what the animal was. For example, let's say a cat or dog or something like that.  And then you have to extract the heart of that animal.    Now the blood will drip, drip, drip.  And as soon as that heart dries up and it no longer drips, that person's heart will stop, automatically will stop from magic. So the alem says that it's narrated in Najaf, that person did that, and he achieved his goal. That person's heart automatically stopped. All of a sudden it stopped. He had absolutely no health problems and there was no evident problem. He was all by himself in his house. All of a sudden they saw that he died. Now are these stories true or not? I don't know, Allahu Akbar. But however there are people that believe there is true magic and it's not all fake. And when we go back to the Holy Quran, the book of Allah Subhanahu wa Ta'ala, Allah Subhanahu wa Ta'ala does speak about magic in numerous verses that I'll mention tomorrow insha'Allah. He does speak about as sahab magic. But however, there is no clear indication in the Quran whether that magic that was practiced is real or it was fake. There is no clear indication. It's still fake. Yes, there is magic. But is it a little clear or not? This is still an area of dispute. It's not clear. But when we come to the hadith of Ahlul Bayt, I'll read you two hadiths about this. One hadith is a companion of Imam Al-Rada, he comes and asks him about the sayah. He tells him his magic real. Is there true magic? And the iman tells him yes. He tells him that it's true. There is true magic. And magicians can hurt you. Don't think that it's all fake. No, they can hurt you. They have the power to hurt you and harm you. So this hadith clearly states that there is true magic and there are magicians that possess this power. But however, there is another hadith that says the opposite. There is a hadith that's narrated by Imam al-Sadaq, alaihi salam, alaihi salam. And the hadith says that one day an atheist came to Imam al-Sadaq and he asked him many questions. And then he asked him about magic. And amongst the questions that he posed the imam, that he posed to the imam, was what? He asked him, is magic real? Do you believe that there are certain magicians that can do real stuff or not? And he asked him this. He told him, can a magician turn a human being into a dog or into a donkey or not? This is an interesting question. Can a magician turn a human being? He takes his wand and he says abrakadabra and all of a sudden this poor human being turns into a barking dog or he turns into a donkey. Is this possible or is it not? The imam, he tells him, no, this is not possible. He doesn't have the power to do that. And then the imam, he tells him, if this person had the power to turn a human being into an animal, then this person would have used his powers to what? To be immortal, to never become sick. Why is it that you find even magicians become sick? Magicians have problems. Magicians many times you find they're poor. If he had such superpowers, why can't he use his superpowers to help himself? So this is a clear indication according to the imam. This is a clear sign that you have to be careful. These magicians are all what? Scams. It's all fake. It's all illusions. Or else if they truly had power, they would help themselves before they would harm others. So there's two conflicting ideas. Is there real magic? Is there not? Like once again I say, Allah knows if there is true magic or there is no true magic. Now the point is brothers and sisters, even if there is true magic, it's very rare. It's very, very, very rare. Most of the magic that we see, it's from the fake magic. It's the illusions. And another important point that I have to bring to your attention is that there is a problem in many societies, and this exists even more in the Middle East, is that magic, the idea of magic and especially jinn, this is blown out of proportion. It's exaggerated. You find some people, any problem that they have in their lives, they blame it on what? On magic. It's a spell. Or it's the jinn.  It was a spell. Someone casted a spell on my poor son. She does not realize that her son never studied, that he was out every day with his friends and he never studied, and that's why he flunked. She doesn't want to say that. She's not aware of that. And thus she blames it on magic or she says it's the jinn. Or many people you find in society, they're sick, especially if it's a psychological sickness. If a person has depression right away, people will say, what? Oh, it's probably a jinn. Or it's probably magic. Someone did magic on this poor guy and that's why he's depressed. There is no physical reason. There's no, for example, medical reason. No, there's a jinn. And that's why if I find many of these people when they want help, I've seen this, they come to the religious scholars because they believe this has to do with the supernatural. This has to do with jinn. And they want, for example, some dua or something to keep the jinn away or to you know, to break the effect of the magic. Most cases, brothers and sisters, are problems in our society. If not, all of them are not from magic. They're not from jinn. There is jinn. We believe there's jinn. There isn't the devil. There is magic. But however, we're taking it out of proportion. We're completely exaggerating the situation. These things do exist, but we ourselves have problems that have real reasons. I have depression because there's a real reason. There's a medical reason. There is a chemical reason. There's something wrong in my body. It doesn't have to do with the jinn. Or many people you find, many women, many wives, they're not able to become pregnant. They blame it on the jinn or they blame it on magic. Or as soon as there's a problem between a couple, a married couple right away, it's blamed on magic. This is wrong, brothers and sisters. This is the wrong mentality. This shows that we have a very, very shallow, a very, very superficial way of thinking. This is a backwards way of thinking. Every problem has its root. It has its reasons. I have to search. I have to search and see what's the problem, what's the reason, and only then I'll be able to solve the problem. So the next time I see a problem in my life, I can't blame it on the jinn. I cannot blame it on magic. Even if it exists, even if it's real, that's not the root of my problem. So this is the third point. Going back to what is magic and what is not magic, what is halal and what is not halal, I said that there are two types of magic, the fake, and we divided that into two parts, and the real magic, and we divided that into two parts, and many ulama, they team all of that as halal and it's magic. Now, when you come, for example, to contemporary ulama, for example, Sayyid al-Khuy, Sayyid al-Khuy, he believes that there is no such thing as real magic. Now, not that he believes that there is no person in this world that has superpowers. No, he doesn't say that, but he says if there is someone that has superpowers, real powers in this dunya, and that is not considered as magic. When the iman speak against magic, they're not speaking about anything that's real, they're speaking about the illusions. So all the ahadith that speak negatively of magic, this is only speaking about the fake magic, because magic to him, he defines magic as what? As something that relies on deceit, something that relies on fooling the human being and creating illusions. So magic means illusions. If it's real, it's not magic, and thus it's not halal. And that's why you find the Sayyid al-Khuy, he says that if you find someone that has his superpowers, this is not considered magic, and it's not halal unless he's doing something halal with it, unless he's hurting people, he's doing something harmful with it. And likewise, the second type of fake magic that we call slate of hands, shabada, Sayyid al-Khuy, he says this is not halal, if someone knows how to do fast magic tricks using the cards, this is not halal. This is using speed, this is using the quick hands. He says this is not halal, and he says that this is not even using, this is not even, I'm sorry, magic. This is called shabada, and it's not a part of magic unless it is used to harm someone. Anything that's used to harm someone becomes halal, so that's not because it's magic. And most of our contemporary ulama, like Sayyid al-Sistani and other ulama, they agree with him, that the slate of hands of shabada is not halal unless it's used to hurt other people.


Thank you all for being here. I'm Andrea Matushan. I'm a professor at Penn State. And it is my distinct pleasure to share the next hour with Dr. Suzanne Schwartz of the FDA. And I realized I owe Anthony Ferrante a mug, because I promised everyone, so there's a de minimis mug that shall be yours. When Q&A starts, I'll produce the mug. Like habeas corpus, oh my, habeas smuggus, I don't know. Anyway, so today we'll discuss with Suzanne some of the current FDA approaches to security and learn a little bit about where we see things going with respect to medical devices and security. But first, I'd love to start with just asking Suzanne, how did you become interested in security?  You arrived in your role. So tell us a little bit about your history and how you went from prior iterations of self to your current job and your deep engagement with this area. And I will say, without a citation, the FDA is probably the most active agency right now in security and kudos to the agency on that. And you're looking at one of the main reasons for the FDA's deep interest and forward-looking approach in security. So I'd love to hear the story of how you became yourself. Thank you. And I have to say that, no, I wasn't born into security. I think when I was born, computer security actually didn't exist, jading myself here. In any case, I'm a physician. And my background in training actually clinically is in the area of surgery, general surgery, specifically burn injuries and trauma, which is far a field from the area of cybersecurity. I've done a lot of work as both an academic, what's called a surgeon scientist. I spent quite a bit of time actually within an academic clinical center in New York City, while Cornell Medical Center, which is part of the New York Presbyterian Complex, doing both burn-related and general wound repair-related clinical care and research. And one thing I would say just about myself is the desire to pursue research and innovation and looking at new approaches, new technologies that can further benefit patients. And that's a common thread really throughout my entire career. Aside from the work that I had done on the clinical side in the hospital setting, I've also been on the industry side. Before coming to the FDA, I worked in the private sector as a medical director of a startup company, a startup that was involved in actually producing and testing a tissue-engineered skin for burn injuries and wound repair. And it was just kind of over the next few years this kind of realization that, for me, being able to straddle multiple sectors of the universe, the research and science side and technology and understanding of the clinical needs, a desire to see technologies get to the bedside. And in that role as a medical director, I did a lot of interfacing with the FDA in order to get clinical trials through and to review and to be part of putting applications together. So there's a certain nexus there that, for me, was very appealing in terms of pursuit of, what can I do to be more impactful? What can I do from a more general broader public health perspective in seeing patients get new therapies? And so fast forward a bit. In 2010, I came to the FDA in a role that's called the Commissioner's Fellowship. It's actually unfortunately been phased out, or it's in the process of being re-birthed as something a little bit different. But the idea of a FDA Commissioner's Fellow, we came in as a cohort, were to really bring in individuals with varying subject matter expertise in different disciplines that may be lacking at the agency. And by bringing in individuals with different subject matter expertise, certainly that benefits the agency by helping us with some of these newer, more advanced methodologies and technologies to help in review of those and in assessment of those. And at the same time, the Fellowship would enable the individual to be exposed to the regulatory framework and what's happening with the FDA. So whether that individual then ends up going back out to the private sector and acting or serving as an ambassador to the environment in which they're going to work, where they understand the how regulation in the medical product area works. That's one benefit. The other benefit is for those individuals where it was determined to be a really mutually beneficial match. So for myself, I was very excited about the work that I was assigned at the FDA when I came as a Commissioner's Fellow. And I saw a huge opportunity to have impact. Very, very challenging and novel emerging areas and an opportunity to learn more and be that continuous constant learner, which is something also that's important to me in whatever I do, so that at the end of every day, I feel, wow, learned something new or been challenged with something different and tomorrow is a new day. And who knows what that's going to bring? In my journey at the FDA, although I came in as a Commissioner's Fellow and then because I'm a physician, that translates to being a medical officer because I was also representing a field that was a very unique field that you don't have that many surgeons around that are burn surgeons. It is a small field, but there were connections to the area of national security and whole hazards types of response. And this was a time period that the FDA was embarking on a medical countermeasures initiative as part of the nation being better prepared to deal with all different types of hazards. And the FDA's role in that is in the regulation, the review, regulation evaluation of what are called medical countermeasures for biologics, for chemical, for rad-nuke related types of events. Because of my burn background, I was brought in to this effort and introduced to it on the rad-nuke side because of the burn injury nexus. But this opened up a whole new vista for me as far as the ability to work across agencies, work across other parts of government, and exposed me to areas or fields and disciplines that were really outside of what I trained in. And I found it fascinating. I found that really being able to work across different parts of government, whether it's within the Department of Health and Human Services with their assistant secretary of preparedness and response, and CDC and BARDA, whether it's with DOD assets, whether it was with other parts of the government of home land security, this to me was extremely exciting and intriguing because I felt that we have not only important role to play and that there is a value that we can add here in a manner that hadn't been really quite captured. For me, this was more fascinating than simply doing reviews of pre-market applications or submissions, although I enjoyed seeing that and being closely involved in seeing or being directly responsible for new technologies coming on the market. This was just a more 100,000 foot, 200,000 foot view of what's happening within the entire health care and public health critical infrastructure is what we call it. One of the 16 sectors of critical infrastructure is health care and public health. So when an opportunity arose for me at the center where I am, the Center for Devices and Radiological Health, to assume the role of director of emergency preparedness, operations, medical countermeasures, I applied for that, I got into that, and it was within that role that we were dealing with, again, all hazards, types of issues, preparedness and response. And I probably was in that role for maybe no more than six months, six or eight months, when we were faced with an inquiry that had come in. Actually, it was essentially a delivery of a package of vulnerabilities, security vulnerabilities of medical devices that was brought forward to us by two very prominent security researchers who worked in medical devices. And between there providing this to our center, along with a communication that came separately from Department of Homeland Securities, what was called then ICS CERT, the Industrial Control System CERT, Cyber Emergency Response Team. This was rather, this blindsided us, I will be very honest with you, because we had never dealt with that before. And we had to quickly figure out, what does this actually mean? What are these, bring 400 vulnerabilities to our attention across all these medical devices. We weren't certain even how to interpret that. And what does that mean as far as next steps, action taken? It was a decision made by FDA leadership at the time, because this was part of a response role, of responsibility at the time, that this would reside in my shop. Did you want to ask something? Yeah. That was 2013. So the thought was we already had demonstrated with respect to other hazards and other public health emergencies around medical devices that were brought to our attention, good processes and capabilities that this should also reside in our shop.  Again, I'm a burn surgeon, doing other things, but certainly not a cybersecurity subject matter expert, or anyone who really had any interfacing with security engineering. And what we needed to do was very quickly mobilize, mobilize a team, mobilize a working group across the center of experts that really took us through the equivalent of the total product lifecycle. So folks who were involved in terms of understanding security engineering and software pre-market as well as post-market surveillance, compliance on the policy side, we have within FDA, surprise, surprise actually, we have an entire office of science and engineering laboratory, which is involved in what's called regulatory science research. So the researchers, the staff there who are researchers, many of them have these capabilities too. And we quickly established this working group and by necessity worked together with DHSIC Assert in partnership and had to come to terms with what do these vulnerabilities mean, what are the actions that we're going to take with manufacturers, and how are we gonna come to some resolution on that. This was, again, spring, summer 2013. The timeframe is important because this was during the Obama administration, in February 2013, there was an executive order that the Obama administration had issued around the notion of strengthening cybersecurity across critical infrastructure, public and private sector working together. There was a lot of emphasis on partnership between the public and private sector. There was a lot of emphasis on also the role that NIST would have, they were mandated at that time to put together through a public-private effort a framework for cybersecurity, strengthening critical infrastructure, and they were gonna convene workshops around the country. And then DHS at that time was also given several mandates through this executive order to undertake, to pull together from across government, as well as through the private sector, different work groups that were gonna be assigned different functions. And so when this hit us, one of the first things that we also recognize is we need to throw ourselves in here, we need to roll up our sleeves, raise our hands to volunteer and say, this is the way that we are going to learn. This is the way that we are going to understand our landscape best and learn through doing and partnering and collaborating. And that kind of brought us to, over time, the recognition that there's traditional stakeholders in our ecosystem, and then there were new non-traditional ones who we had never interacted with before. Security researchers, white-head hackers, whatever one wants to determine. Our feeling was, this is a community with whom we've not engaged. They don't know us, we don't know them. There's a necessity to work together. The value that hackers bring to the medical device space is enormous. I emphasize that because medical device manufacturers have the capability of being able to design devices with safety in mind, with safety and effective performance. But the notion of building security in by design was something kind of a very new and foreign concept. And here we were gonna need to really shift the culture and the way of thinking around new devices coming on the market. So, we probably released the pre-market guidance draft got written and released in literally like six weeks. That is just something that was a miracle. That like never happens. But it was recognition that policy has to be, the policy needed to be in place. And we subsequently finalized it over the course of the year and convened our first public workshop in 2014 around medical device cybersecurity. And it's an interesting workshop if you were to go back and watch the webcast or listen to it or look at the archives because there are a lot of the stakeholders in the room who viewed themselves somewhat adversarially in years past. So the security researchers, manufacturers, healthcare organizations, other government agencies and the idea of this was to really foster open dialogue and to allow for the pain points that different stakeholder groups are experiencing for them to be vocalized and to not necessarily come up with solutions. We weren't gonna have that happen in two days but we had to give voice to everyone who deserves a seat around the table. And that has been a critical principle that we continue to amplify over the years, this importance of hearing from every stakeholder that's involved and recognizing the value that different stakeholder groups bring, particularly because we know that cybersecurity within this space as in other spaces is one of really that shared ownership or shared responsibility that we talk a lot about. So we've emphasized whole of community, not just whole of government began by really reaching out to security researchers. I am the cavalry has been had a major, major impact on the work that we've done in these years, really back from 2013, 14 to the present. And I can't even quantify what extraordinary benefit we've derived from that relationship that we have with I'm the Cavalry and the role that they have not only in having educated us around the challenges that are faced in the hacker universe, but also an opportunity for them to help inform us with respect to policy issues and areas in other sectors, in other industry verticals that we are able to learn from and to take those experiences and apply them within the healthcare and medical device space. How did the approach to the post-market guidance that was really subsequently changed from the way that the pre-market guidance was? Yeah, so very thoughtful and deliberate and intentional. So while we were kind of going through all of this, we also are continuing, let's remember, to get vulnerabilities brought to our attention. Things just don't stop. And we have to think about how are we handling these vulnerabilities? How are we managing them? What are our expectations of manufacturers? Because we had already established a lot in the way of a network of friends. It's like call a friend, right? Being able to have a very broad network of subject matter experts to help support and inform the policy approach we were going to take was very, very different than where we were a year and a half, two years prior. And so while we issued the post-market, initially as draft in early 2016, we'd been already working and socializing the concepts and a framework behind it for at least the 12 months prior. And that was critical because the way FDA works with regard to guinances, if we'll issue something as draft, there's an open common period, a public docket that is opened. It's generally a common period of around 90 days. Sometimes it's extended for longer than that. And then we'll look at those comments, digest them and determine in finalizing the guidance of what is appropriate, what we think is going to make for a more robust guidance, one that is implementable. The implementable piece is also critical and that plays a very important role with the post-market guidance. So the fact that we had done all of this kind of socializing and homework in advance made it much easier to finalize this guidance. It was issued in January 2016. It was finalized by December 2016 also. A very, very quick turnaround for government within a year to go from draft to final. But it's because we had already addressed a fair amount of what we thought would be feasible and what we thought would be the right approach to take. But importantly, there were certain ambitious goals that we had set forth in the draft that the hacker community had come to us and said, based upon what's observed in other industrial control system sectors, don't think that you're gonna get that, you know. You may wanna think about the crawl-walk-run approach. You may wanna think about, you know, while you're really bringing industry up to speed here and raising the bar, that's done more incrementally and some of the expectations that might have been set in the draft may have been a bit too ambitious. And we took that in mind and did further tweaking on it and have since, you know, reissued it. I think we still have an ambitious goal there, but we're seeing that manufacturers, for the most part, are striving to attain that goal. The other piece of it that was important is to build in a regulatory incentive. So that was another element of the post-market guidance that we thought was really very, very important that it be clearly articulated. Some of the differences that you have in traditional medical device-related management and what our expectations were with cybersecurity that manufacturers be far more nimble that they accelerate the type of assessment of vulnerabilities, validating them and remediation of those vulnerabilities. And they do that in a much more accelerated timeframe than what would otherwise perhaps happen with other types of device-related malfunctions. And so that was one of the reasons why we built in certain incentives to try to push or drive for a faster type of response, which, as you can imagine, in cybersecurity becomes really critical to do. Yeah. So, yeah, the question was, I had made the distinction that in the draft guidance, we put a very, very ambitious timeframe down in the final guidance, we pulled it back a little bit. So if I'm remembering correctly, and Seth is here as well, in the draft, I think that we had only inserted like kind of a sense of a 30-day timeframe all around for really being able to, once the vulnerability was discovered and reported to the manufacturer at being time zero, they really needed to be able to do a full assessment, validation, determine what needs to be done in order to reduce the risk of that vulnerability and communicate it out and take that action in a 30-day timeframe. So that's pretty aggressive. What we did was we still wanted to kind of demonstrate and really push industry to understand that what we're talking about, we're security and safety are crossing over and safety issues are really critical to us here. So we offered, we provided a 30, what we call the 30-60-day timeframe. So 30 days being from time zero again from when awareness of the vulnerability going through the assessment and all of that process with the expectation that manufacturer communicate by the end of 30 days around this vulnerability, what its potential impact is and at minimum what compensating controls or temporizing measures would be available in order to reduce risk. And then in the following 30 days, so that would be 60 days total, that a more definitive fix would be available and for deployment and subsequent communication with that. So that was the more measured, if you will, or more moderate modified, excuse me, timeframe. Yeah. So the post-market guides comes out and there have subsequently been actions taken by the FDA including some recalls. Can you talk to us about some of those recalls? Yes, yes. So I referenced the fact that we built in a regulatory incentive. So I need to just explain what that incentive is to explain what the recalls are about. The regulatory incentive is to kind of drive towards a compressed timeframe and we put in three criteria within the post-market guidance that if you meet that timeframe that you and that secondly that there have been no adverse events, no injuries or fatalities as a result of this vulnerability. Therefore it's not been exploited to the manufacturer's awareness. And the third one was the manufacturer must be a active participant in what we call a medical device, ISAL, vulnerability ISAL, information sharing analysis organization. That parenthetically, the ISAL concept also came out of the Obama administration. It was through an executive order that ISALs kind of formed as kind of small satellite communities where there would be information sharing across those. And we recognize the criticality of information sharing within and across industry as a means of being able to disseminate information more rapidly around vulnerabilities that may not necessarily impact one manufacturer but may impact many to really try to, again, institute a more proactive posture. So those were the three criteria that what we described in the post-market guidance, manufacturer, if you meet those three criteria, then we will not enforce what's called part 806 corrections and removals, which is essentially a voluntary recall, that we would use enforcement discretion. And for a manufacturer, that would be a good thing because going through a voluntary recall process brings a lot of attention. There's a lot of administrative stuff that goes along with that. So if there's another way to do that, which is going to accelerate a fix and alleviate from the manufacturer the need to go through this formal process, that would be good. At the same time, what's therefore implied, actually stated within the guidance, if you're not able to meet all three criteria and we provided examples of that in an appendix, well then you're obligated to go through the normal part 806 corrections and removals, then you're going through a voluntary recall process. And we recognized dealing with a rather immature ecosystem anyway and some very difficult challenges with some medical devices that 60 days is likely not going to be enough for certain devices to have permanent fixes associated with them. So by nature, we knew that there are going to continue to be recalls over time because it's just going to be a difficulty for manufacturers of certain types of devices to be able to not only do that full validation and assessment, but to actually be able to create an appropriate update or patch or fix that has to also be tested, right? It's got to be tested to make sure that it's not going to interfere with the device's safe performance. So that within 60 days may represent an impossibility in certain situations. And in those cases, a manufacturer's going to need to undergo a full part 806 with a recall. So I can't quote you a percentage. What I would say to you is the following from anecdotal from our experiences thus far. And that is that the, well there are a few conditions here to talk about. Number one, the implanted, the implantable devices represent the hardest fixes. So if you want to think about the pacemakers, the ICDs, you know, the implanted defibrillators, neuromodulators, deep brain stimulators, things that are implanted are going to represent a much more complex fix and deployment. So now they don't represent a huge percentage. We were looking across the entire medical device portfolio of devices that we regulate. That's not a huge chunk, but you have that as one consideration. The other important consideration which is relevant to this discussion also is that we've seen a fair amount, particularly with these or high consequence types of vulnerabilities, what can be debate or disagreement across researchers and manufacturers or researchers, manufacturers and government with regard to what we like to call ground truth. Is this vulnerability, first of all, real in the sense of does this exist? Is there, has there been an ability to validate its presence? And more importantly, or by taking it a step further, the impact of that vulnerability and the severity of that impact where its capability of introducing patient harm that we call uncontrolled risk or risk that we would consider to be not tolerable from the agency's perspective. Not tolerable in the way it exists and therefore requires manufacturer to do something with that device to reduce that risk to an acceptable level. So when you have disagreement across parties with regard to how to assess the assessment of that vulnerability and its impact, that already is going to prolong the timeframe out of the 60 days. So that's the other piece also that has resulted in some of the recalls that have been public. Getting to that ground truth has been a very complicated process and because it's well exceeded 60 days and it's been months in some cases we've had a few that have gone a year and a half or longer that has necessitated a recall. And so now we have draft pre-market guidance as an update. Can you tell us a little bit about that draft and what the next steps will be? Yeah, yeah. So one of the also important principles where we started out from is that with cybersecurity really rapidly evolving and knowing where we and the ecosystem were starting, we recognize that this is an area that we are gonna need to iterate on on a continuum. And now what we issued back a few years ago, that's fine for a foundation as appropriate as a baseline kind of setting, but given everything that we have observed, everything that we have learned and that we've experienced over the past few years, whether it's wanna cry as an example or not pet you that was talked about earlier, whether it's vulnerabilities that have been brought to our attention by security researchers, we recognize through those learnings that yeah, we gotta be continuing to raise the bar and our expectations of manufacturers are that much more rigorous than they were in 2014. So 2014 sets the floor and the principles upon which we continue to build. Did you have a question? Yes, I do. Yes, yes. And those are examples of where we've had this protracted phase of trying to get to ground truth around vulnerabilities where we have had to insert ourselves as part of that process, working together with the security researchers, working with subject matter experts that are technically capable of being able to further understand exactly what the researchers have been able to demonstrate and working with the manufacturer. And that is a challenging space, one that I'll take a detour for a second is a reason why we put forward in 2018 in the spring, a medical device safety action plan for medical devices in general with an entire section on cybersecurity. And we put forward a proposal there for something that we call the SIMSAP, a CyberMed Safety Analysis Board. And the concept behind the CyberMed Safety Analysis Board is just that, recognizing that we are challenged today, we have a gap of knowledge and understanding within the ecosystem where you can have vehement disagreement across different parties as to not just a vulnerability's existence, I think that we can get to that point but what is the impact of that vulnerability from a clinical perspective and therefore what action would need to be taken? So having an entity that's more of a neutral body, a neutral entity that's a public private model that includes technical experts, clinical experts, engineering experts, security experts, that government has a seat at the table as well but government doesn't own this entity, thinks somewhat like akin to an NTSB model, not exactly like that but the idea, and not waiting for something bad to happen but rather when a vulnerability of this high consequence is brought to our attention, it's, you know, we find ourselves having to reach out to multiple parties trying to get to this place of understanding really what the impact of that vulnerability is. How much better would it be if there was a pre-positioned body of experts that are able to come together in real time to fully assess through each kind of expert's lens through different disciplines really what the impact is of that vulnerability and what are the necessary next steps to take? So that is something that we are proposing for initial seed funding. We're hoping that we can get some funding for that with the idea of it being subsequently owned and operated by the public-private sector kind of through a public-private sector model. But going back to the new pre-market update, so in reflecting on what we've learned, we come to three basic principles. We call them trustworthiness, transparency, and resilience, recognizing that we've got to build those foundational principles into everything that we do. It has to start with the pre-market but it really goes throughout the entire post-market lifespan of a device. However, you're only gonna get to that if you build it from the start, from scratch, with all of those concepts in mind. And so we released that in October. Some of the key elements there that were really important, ah-has for us, number one, was the concept of bill of materials, right? So WannaCry had transpired and recognition that you can only protect what you know that you have. For an end-user organization, for customers, for healthcare organizations, that have thousands upon thousands, if not in some cases, millions of medical devices residing on systems, how can they possibly protect their systems, protect the devices in terms of their performance if they do not know what the composition is, the components are of those devices and whether there are vulnerabilities that have already been identified within those devices. So while, you know, we are heavily engaged in a fantastic effort, a multi-stakeholder effort through NTIA, Department of Commerce, the S-bomb Trends, or the Software Transparency Initiative, which is fantastic. At the time, we also thought we were gonna kind of even raise it a bar further and say, well, it's not just software, we're concerned about hardware as well. So we called the S-bomb in the draft guidance, the Cybersecurity Bill of Materials, with the expectation that manufacturers actually would have to provide that to their customers, not just to us, to their customers. We've had a workshop since our docket as well, the comments have come in and there been recognition across the board by people that are a lot more knowledgeable and experienced than us, that that's great and that's aspirational, that's maybe taking it down the road. Really what you wanna start with is, let's get that S-bomb, let's get that softwareable materials in place. So as we're in the process right now of revising and kind of taking into account the comments that came into the guidance draft that we updated, the update that we issued in 2018, we're gonna put that back as S-bomb, as opposed to C-bomb. And once we get there, then we'll move forward to C-bomb as we continue to iterate and make things more rigorous. Some of the other pieces that were important there was putting in an expectation that manufacturers have to include threat modeling and documentation of threat modeling in the design of their devices. Third item that was really important was manufacturers need to include in their pre-market submissions evidence that devices are capable of being updated and patched through the lifetime of their device. We are dealing with the pain of legacy devices right now that has been an area that is gonna be very difficult to address over the next few years. What we can do while we're trying to address that through one arm, certainly with new devices coming on the market, the expectation that they have greater resilience, that they are capable of being updated and patched, we want to see that as part of the pre-market submission, not to find out once a device is in use that this device is brittle and any attempt to trying to update it is actually going to knock over the device. So those are some of the concepts that we incorporated within the new pre-market guidance. And we're, again, once more in the process of revising it right now with the hopes of being able to release it again by the end of this calendar year. Okay, and to maximize time for questions, I will open it up. Are there any other questions that we can engage on? Could you use the mic? Thanks. Yeah, really good question. I think right now we are also dealing with the reality at FDA that we are responsible for making changes that were mandated by 21st Century Cures Act as well, which brings into account a lot of interesting questions around products that have some functions that are considered medical device functions upon which we have direct authorities and some functions now which may not actually be considered medical devices. So you can imagine how sort of convoluted that can be as far as how to approach that from a cybersecurity perspective. Trying to create an artificial walling parts of it off from what we would look at versus what we wouldn't look at is very complex. We're working through some of those challenges now, but what I would say is the following, and I had this aha moment actually when I was sitting and listening to Alan Friedman the other day, I'd besides talk about the software transparency initiative, the effort, and the group's work in terms of defining, well, what exactly is SBOM? What really is it? And he said where the group had come to was X includes Y. Let's not talk about functions right now or let's talk about what's included within that. And for me that really resonated because that meant the SBOM is really intended to be that protective measure, that ability to mitigate for the end user, for the customer. And so trying to separate out or divorce out pieces of it that would not necessarily be under our authority doesn't make sense. As we look towards SBOM, we would be looking at the product in its totality, even those components of the product that may not necessarily have a direct medical device performance function. But that wouldn't matter to the end user, right? Their concern is for the vulnerability and their exposure. So that's kind of how we're thinking about it right now. I was curious about the scope of the vulnerabilities that your team is responsible for addressing. Is it just physical hazards or the function of the hardware device? Or do you also look at things like user privacy, for example, or other? Yeah, that's a really great question. I didn't cover that at all. So the interesting thing is that across the Department of Health and Human Services different agencies, different operating divisions have different authorities that they are responsible for. O&C, I'm sorry, not O&C, OCR, Office of Civil Rights within HHS is responsible for HIPAA privacy and security. That's not under our remit. And so while we would not minimize the importance of privacy, of patient information, clearly that's very important. Our authorities and our mission is specific to the safe and effective performance of devices and protecting patients from physical harm if the device was not performing properly or was not performing at all. So what we did in guidance that we've previously issued though is we stayed very clearly. Manufacturers, you are still under other obligations that you need to abide by, including HIPAA privacy and security. Here's what we're doing to make it easier for you to abide by that. So we have something called controlled vulnerabilities, vulnerabilities that in their assessment don't necessarily result in a patient harm. What we've said there is that changes that are made solely to strengthen cybersecurity and data privacy related issues would fall in that category. They are considered, from our perspective, routine updates and patches. They do not come to the agency for a re-review. Manufacturer, you should just go and do that. You should just take those proactive steps to make sure that you can then be in compliance with the other regulations under other parts of government that you are required to abide by and we're not going to impede that process. We're not gonna delay that because we say we need to see those. We do not need to see those. Other questions? What do you foresee to be the biggest challenge going forward in the next five years for the FDA and the point of security? Biggest challenge. There's a few of them. Some of them are wrapped together. I think that, I think holistically across the ecosystem, so it's not just FDA's challenge and this is where we really have to bring other parties together. It is the legacy system and the legacy device issue. And I mentioned that because of the economics associated with that as well. And the recognition that while new devices can be made available to healthcare organizations, healthcare organizations are not necessarily well-poised financially or through their business models to be able to take in those new devices in order to get rid of the old legacy drag. And so you're left with certain systems that are not capable of being updated and patched and you're left therefore with certain exposures and vulnerabilities and recognizing that a cyber campaign can occur at any time and can exploit these vulnerabilities that leaves our critical infrastructure vulnerable. So how do we address that from a multiple facets? Recognizing that yeah, we have some tools in our back pocket that we could pull out. Some of them are a little bit drastic that we would rather not move to. We'd like to figure out through efforts of the public and private sector working together and there are a lot of different consortia doing that under even what's called the big umbrella, the healthcare sector courting council to really analyze some of the economics here and then what are the options, what might be the incentives that could be put forward to get these really older devices out of use and bring newer devices that are more rigorous and more secure in place. I don't know Seth if there's anything that you wanna add but we've got lots and lots of challenges of different scale but when I think of something that's really big scale that's gonna require a whole universe of effort that's probably one of the biggest ones. And with that we will have to wrap things up. Let's all thank Dr. Suzanne Schwartz for joining us today and let me thank you by encouraging me to take a sticker on your way out. Thank you. Thank you.


Everybody for a stripping 2022 triple threads baseball hobby nine bucks case number 59 pick your team style Andrew are with the Diamondbacks Chad W. Tigers Chris D. Braves Christopher L. Padres Daniel B. Phillies David L. Red Sox Cubs and Rockies Edward P. White Sox Eric R. Angels Mariners Yankees big teams for Eric. Good luck, man Gwen C. Astros Greg B. Guardians Harry C. Ray's Ian R. Cardinals Jake S. Twins John M. A's Keith J. Orioles Costa K. Blue J's Kusey R. Nationals Matt B. Metz Matthew K. Brewers Peter M. With the Reds and the Royals Robert G. Giants Scott F. Pirates Dodgers Shane W. Marlins and Viviana with the Rangers. Good luck everybody. Thanks for joining Sampoors milk and his bowl before the cereal. No, Sam's all right. Oh Sorry, Ryan to be fair Ryan. I did not gather those boxes They were they had already been gathered and tagged by I believe Cortes I had nothing to do with your actual boxes. They were already on the table when I got in here yesterday with the judges Who's that? Added to Marco Oh, yeah, yeah, white lotus. All right. Yeah, I know that is kind of like I know of him Did they're not gonna show the names? Oh Street Prop. Oh, that's pretty cool wrestling WWE. Oh, gotcha All right, let's do it y'all. Let's pull a wood card tonight or a bat-knob or a cut auto Posey for the Giants to 259 and never to 299 rookie O'Neill Cruz for the Pirates Braves John Smoltz Shipple Threads Relic Auto 9 of 18 dual threat. Cory Ozarenko. Wow Legend and Jersey card Christian Yelich to 36 Brewers Game used who was the final male judge? I forget Gotcha Suzuki to 125 building maze for the Giants in a 199 wheelie maze for the Giants A triple patch Braves Ozzie Albee's on the all-star game two of nine really sweet card there for the Braves Event worn memorabilia Jersey Auto Blue Jays Alec Monella 28 of 75 who says they won't be the punching bag Yeah, right Yeah, I don't know Ryan your bangles fan. So I'm sure you've been down that road many a time We got now Oh, Mitch Marner Tough skin being a Cincinnati fan, I guess to 150 Vladdy Jr. Blue Jays to 199 Peter Lanzo Mets Hey big dumper on the Jersey rookie auto There we go 67 to 99 Mariners And Jersey card Durand rookie for the Red Sox to 48. There is a You scratch. Yeah, it's like a weird scratch. I'll sell the Boxer rapper as for sure pack damage It's not like some normal light scratch. It's like a fortunate deep scratch Yeah, we're I've never seen that on triple dads card before to be honest Now you sound like everyone else in chat, Ryan To 259 rookie Jaren Durand Red Sox and a 299 Yankees Lou Gary One of one ruby triple patch card for the Reds hunter green joey vato jonathan india All game used mem That's sick for cincy Peter M. Congrats Peter Three colors on every single patch or some dirt on the india as well That's sweet ruby one of one Color match to you gotta love that and Red Sox Jersey out of bobby doll back to 50 He's ugly okay, so I figured but it's like some Just where he didn't have a jersey skill trick shot something bobby wood jr. Bass The 299 trade turner Dodgers to 50 Roy Campanella Dodgers Jose Ramirez guardians to 27 triple relic auto triple threads relic auto spring star Jersey Cardiola Jimenez white Sox to 27 you start talking back first Ryan I never instigate When I'm breaking that's true Now if I'm in chat it's different. Yeah, specify. Yeah. Yeah. Yeah, like when I'm breaking I never instigate I'm like the moderator of all things Yeah, shroud to 259 angels and a 299 will be maize giants Triple relic Ozzy Alby's to net 36 for Atlanta and rookie auto Louise heel to 199 Yankees Coleslaw Carl, did you order a personal did you just go for uh for breaks? Yeah, but I I really did not gather those boxes. It was Cortes. I don't remember There's two were tagged when we came in Donnie's no help I'm not getting involved Wise wise Oh, we got a white whale coming up in a second here. Who's it going to be? To 99 reds johnny bench and to 259 red Sox trevor story White whale blue jays rookie printing plate triple patch auto auto Lopez Cyan printing play with the pretty much blue jay color match also There we go On the plate too. Gotta love it. Fantastic patches Jersey card to 48 JT on Muto for the Cardinals or sorry Phillies Phillies are on Muto to 48 So 150 Tom see for Mets the 25 rookie Jairnder and red Sox Can we get talking to? Triple jersey Elohim in as the 36 white Sox I'm gonna get the The grandma like finger wag tre mancini jersey auto to 99 Orioles Always sounds good as nachos That is back something about chips covered in cheese and meat and sour cream and Tomato or like whatever. I don't know whatever else guapo. Yeah Pretty much. I pretty much take anything on it. You can put beans up there. You can put jalapenos to do whatever some green onions All right, let's not get carried away. All right, donnie doesn't like veggies apparently fried food also It's a 50 fruity Freeman Dodgers. Yeah, the only veggies donnie eats are like fried potatoes Legend I cut triple relic coward can jr to 18 Orioles Loaded tots are good too. Dude, I forget where uh jersey auto sunny gray to 75 twins I'm not sure if you guys have world of beer near you But there's a lot of world of beers in like Florida area They get originated in Tampa, Orlando But anyway, they issue loaded tots and they would use their house beer cheese fresh jalapeno I think like pork belly And there was one other thing Anyway, they were fire. Got them all the time. They were like unhappy hour when I would go They're perfect. They're perfect. Anyway, the 150 Luke Garry Yankees and a 199 George Brett Royals Nationals triple jersey auto Luis Garcia to 75 Nats future phenoms and bat relic Kyle Lewis to 18 mariners gilded a rinse Something about getting a fried ship or like a fried You know fry or taught you're just loading it up. It's always the best like zinger mountain melds They used to be a lot better, but they're still pretty good from uh alehouse Alehouse, that's a pretty good food For being like a sports board type place. Yes We're going to get like wings or like fry stuff. Even some of their like like Cajun chicken pasta there is good as well. They're they're uh ship roll fritos really good too So I'm saying for being like a sports board type place. They have actually good food. Yeah, it's surprising It's like it's at least on like an olive garden level. Yeah I'm not saying like I would oh, we should we get Italian food.  Let's go to alehouse It's 125 blue jays. Vladdie jr. To 199 same guy Yes You can go there with people that Want whatever you get whatever to back to back on the triple jersey to 27 Tatis Padres game used And a reds rookie auto card gold parallel of hunter green redemption When you hear your family that that is what that's that's what uh Olive garden right when you're your family I know I legit have not been to an olive garden at least nine or ten years Right, but like I don't I also don't have teeth. I don't have k-word. Now. Let's do commercials One of my one of my roommates used to work and he's not my good friend But used to work at olive garden when we were in college And he always used to wear these dumb buns.  I just I haven't eaten at an olive garden. I've had it take away I haven't eaten at an olive garden in at least 10 years. I'd say triple jersey auto cardinals dillon carlson at 25 There we go, but I've had like catering or you know, like takeaway a few times It's good. It's fine Patch card out two vates of three astros I think there's a bit of dirt on this gray jersey. It's tough to tell without putting my face right next to it So i'm not gonna do get your face all breathe on the card Is it really game use smell it donnie? grass When you're here family now go to the dishes. Yeah, exactly Mustard cats You see sorrows Who's that that's connor hella buck He's the jets goalie Oh wow donnie jeez man, look at that stash steward skinner with the all-time stash Take notes. That's a goalie stash for sure though It's like ucf jersey the vagus one. They are the knights Logan thompson, Logan's awesome man. What a surprise. He's been Surroken All right, gold spit the 299 cardinals and 125 louise robert white socks triple jersey rookie auto read denmers to 50 angels Yeah, we pulled a no-vechkin on card auto to 28 actually So we pulled a quad game use patch card Uh for cracking uh cracking quad cracking game use patch card is really nasty 36 mic trout angels on the game use jersey Like brad stepping to soccer Alex I do all the dishes at my house. My wife does the laundry because I hate it, but I do I do dishes I don't know why I like doing dishes more, but I just prefer that Do you not have a dishwasher? No, we do but like I still unload loaded up if there's something big I'll wash it, you know Abrams to 259 rookie nationals to 299 rizzo yankees heart and hustle altube game use to 27 astros I do most of cooking at home when we're at home as well Oh Jersey auto blue jays alec manoa at a 99 But like she'll sweep and vacuum it like mop because I don't like doing any of that stuff And she'll do like laundry But I'll like to make the bed. It's weird. I don't know I'll wash like the linens and she'll wash like the clothes. I don't know dude. Just as how it goes I can't explain the reasons why I mean Judgment free zone here No, it's not Donnie said this is judgment free zone What an absolute lie. I don't know you can tell the sarcasm there, but I don't judge the people in chat But I know we get judged. That's what I mean Jayrod base Hey, what's up, Brennan Freeman to 150 Dodgers and the 190 on Luke Garry Yankees Brewer has been cut in triple relic to 36 Slam in a pinch And rookie auto angels redembers to 50 again Oh Yeah, Rusley. Yeah, the never ending pasta stuff. Yeah, that's that stuff is insane even like endlessly soup salad breadsticks I'm sure people take Like a normal person goes and has two maybe three servings of whatever. I'm sure there's people that go there and just Do not great things in disorder like Eight orders, you know, it's 199 Votto for the Reds to 75 Lattie jr. Blue jays and then tip poorly as well Scott Rowland redemption amber triple threads auto relic parallel. There we go Cardinals the recent Hall of Fame inductee I think the blue jays are like the base complete for Vlad yeah Jersey card Manila to 48 blue jays Uh, abs it. Okay, Brennan. I remember there was a new hook to 25 just a base parallel And like there wasn't enough to 500. Um Uh, what's your defenseman's name macar camacar? There's nothing there was no hits though for the abs. I'm pretty sure though in both cases, which is weird Which is weird Oh, we're there Carl. Yeah, there's a lot of parallels for those for the abs This is an absolute judgment zone We don't judge the new people but if you've been in chat a while and are here all night every night Yeah, I guess so But if you're new we're not gonna judge you At least I won't Give us like a week while you're here Bryson Stott to 299 Javi Baez tigers to 99 willy mays giants Triple relic Javi Baez game used with 36 tigers crime resume Jersey auto Orioles train man senior to 50 He judged on I'm not oh, I guess I'm the newest here. So that's why you gotta judge him the hardest All right, I get judged a lot. It's all right. This is how it is to 99 roi campanella dodgers into 259 chipper jones braves Don't know. What if you were in the bad batch? How do you think? Omega would say your name Tony Tony Tony rookie triple patch auto fillies matt veerling the 35 great fillies patch on the bottom there It's the player worn patch And jersey card mani machado to 27 for the Padres There we go solid case there nothing crazy huge But there were some nice a couple of one-to-ones and some other nice triple autos or triple relic autos and such We'll do a recap here I did one of those things we're like I like pinched them and they're just like I don't know. I don't know how to explain it Too many cards go too many places. All right relics to start the redemption christian yellich jaren diran ozzy alby's all-star triple patch illy him and as j.t.l. Muto ozzy alby's illy him and as mani machado hobby or bias Alec monella andrew mccuchan jose al-tube Mike trout jose al-tube to three Tatis kyle luis cowerpkins jr Autos now matt veerling Trey mancini scott rolled in redemption for the cardinals triple dreads auto relic amber should be to 18 Cardinals rolling redet mers alec monella Redet mers Dillon carlson at 25 hunter green gold rookie auto redemption for the reds louise garcia sonny gray trey mancini louise heal jose ramirez to 27 triple relic auto Guardians bobby doll back cow rowdy on the jersey rookie auto big dumper other alec monella john smoltz to 18 for atlanta white whale one of one triple patch rookie auto printing plate auto lopez for the blue jays And one of one triple patch reds hunter green joey vato jonathan india Game used That'll do it. Thanks everybody another case of triple threads coming up