DarshanTalks Podcast

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have a two for one, we have two amazing, amazing guests, and we are going to be discussing incubators, accelerators and how the world of growing your startup is changing.

Narrator: This is the Darshan Talks podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: We have Kate Merton and Julia, and we'll let Kate go first and then have Julia go next to introduce themselves.

Kate: Hello, my name is Kate Merton. I'm the staff VP in digital care delivery at Anthem. Prior experience, I've worked at JLabs, which is Johnson & Johnson's incubator, and I have a background in healthcare discovery in the commercial.

Darshan: Very cool. And Julia?

Julia: Hi everyone. I'm Julia [inaudible 00:00:59]. I am currently at Anthem as well. Previous to Anthem, I was at Johnson & Johnson. I hopped around their innovation group, their innovation centers, and then also at JLabs as well. Happy to be here.

Darshan: Awesome. I'm excited to have both of you on. So we're going to keep this tight, Kate and Julia. Let's start with a basic question. What is the difference between an incubator and an accelerator and does it matter the practical level?

Kate: So I'll start off and then ask Julia to weigh in. I think the definition of both is, I don't think anyone's actually put it in a dictionary, but from my perspective, an incubator is an organization which has pulled together different tools and resources in order for entrepreneurs to build up their business and find a path to market.

Whereas an accelerator, I often see as part of an incubator because it is a time defined program that brings a company and puts it through a very clear curriculum of what they need to get done, but they are kind of like brought in and then pushed out a certain time.

Whereas an incubator isn't necessarily time defined, but they may provide the same resources.

Darshan: So, Julia, do you have anything to add there?

Julia: My only comment is I feel for incubators, there tends to be more of a one-on-one approach with the companies, just on how they incubate and companies supporting them individually. Whereas I feel accelerators tend to be a little bit more for a group perspective, but the growth, everything Kate said.

Darshan: So if that's true, if I am a brilliant scientist, I've come up with a brand new drug or biologic and I'm going, "I want to bring it to market." And I'm trying to choose between, do I go with a big pharma incubator or go with someone like Anthem? How I'm making these decisions? What considerations do I have as I'm doing this?

Kate: That's a really good question because how you set it up actually kind of pre-defines how you're going to answer it. If you are a startup with a molecule that lands in the pharma world, you are probably going to want to go to an incubator, just for what Julia said, which is a more one-on-one high touch experience, because we all know that developing a drug is inherently difficult and problematic.

You are not going to be able to get in an accelerator, which is a little bit more like preformed, exactly how you have to navigate. Developing a product, it goes beyond, I think what you could get out of an accelerator. They might be able to give you like a start of how to run a company, but the actual process of how to work with your product and get it through approvals, everything else. That's going to be more suitable for an incubator.

So whether you go in an incubator versus an accelerator, I believe very much depends upon the products that you are selling.

Major: This is the Darshan Talks Podcast. Today, we're going to be talking about why do you need a clinical trial transparency program? I hit that right or was it a strategy involved in that somehow, Darshan?

Darshan: No, it's really going into why you need it in the first place.

Narrator: This is the Darshan Talks podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: You've sort of done a couple of podcasts on how do you do it right? And what are some components of it? But a really good question, a really good basic question that we probably need to answer is why even bother having one? And I think the number one reason is because legally from a legal and regulatory perspective which is what matters to a lot of companies, you're required to have a way of actually disclosing a lot of the results associated with this. So you need to have an overall strategy so that you aren't reinventing the wheel each time. So that's number one, just to meet legal regulatory requirements.

Major: Oh, we're making a list on this one okay.

Darshan: Yeah.

Major: So number one don't reinvent the wheel every time.

Darshan: Exactly, right. Number two, because you need to understand if you're developing other programs whether it's a publication program, whether it's a privacy program, how does all this connect to your transparency program? Because if you're going to say that we're not going to disclose anything well, what does anything mean? Because you may be required to disclose things under your... So if your privacy program says, I won't disclose anything, but your transparency program lands up requiring you to disclose things it's best to get those both out simultaneously so that you have a clear process on how it's going to happen.

Number three, because it's often just the right thing to do, because you've got a situation where you've got patients and participants who are often engaging with you early on during your entire development process, they're helping you understand what is expected. They're helping you be part of your products development strategy. They're helping you recruit new patients, new subjects and when all of that is happening and they're often risking their life participate in your study depending on what type of study it is. It's only right that they be able to get the results, they have an understanding of what studies are happening and that patient-centricity becomes a core goal of your process. So I think that was number three was it?

Major: Yes.

Darshan: Okay. So another-

Major: So just to go over what we just went over. Number one, don't re-- why you need a clinical trial transparency program? Number one, don't reinvent the wheel every time so you don't have to do that. Number two, you need to answer the question, how does this connect to your transparency program? And if your transparency program requires disclosure, you want to do that. And number three, it's just the right thing to do.

Darshan: Yeah. Another reason you might want to have a transparency program is because you are developing an overall strategy and you're going into different countries and you need to be able to understand what that country's expectations are and you're looking to publish in the journals associated with those countries. So if you're doing that, you need to understand what those requirements are. So if you don't have a transparency strategy, you're going to be reinventing and creating a new paragraph for the overall strategy each time. And we've seen clients do this before, where general X will say, "What is your transparency program?

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Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. Today, we're going to talk about six considerations in creating a clinical trial transparency strategy.

Narrator: This is the DarshanTalks Podcast: Regulatory Guy, Irregular Podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Major: Darshan, kick it off with number one.

Darshan: Yeah. So, well, I think the biggest problem most people have when they're creating a transparency strategy is they start putting the cart before the horse and they start going, "Do you have a template I can use?" And that's actually problematic because whoever's giving you a template needs to understand why you're doing what you're doing.

Major: These templates are online. It's also like what they've done previously in other scenarios and what they've also advised on, right? It's not just-

Darshan: Yeah, so sometimes it's competitors, what have competitors done. And they'll sort of point to that and just wholesale take that template. Except your competitors are working their own problem. What's that?

Major: Why shouldn't they just look at a competitor and say, "You know what, I like what they're doing. Why can't I just do that? And let's move on. Let's go to the next step."

Darshan: We'll actually talk about... Well, let's talk about that. So when you're talking about competitors, competitors are often, first of all, they have their own considerations. So they might be a different size. They may be dealing with different patient populations. They may be working with a different market cap. They might be privately held versus publicly held. Each of those will have a dramatic impact on their publication strategy and on their actual clinical trial transparency strategy. So you trying to suddenly go, "I'm going to match them," is problematic. The additional consideration that comes out of this is who are your competitors? Are your competitors people who are the large pharma players, like a Novartis or a Pfizer? Or are they more companies of your size, which may often be niche players. I've worked with clients of multiple sizes. I've worked with clients with rare disease states versus less rare disease, shall we say. And the implications are different. The types of goals you have are different. And that causes just wholesale copying of a competitor, not the best place. So that'd be number one, knowing what your competitors are doing, but understanding who your competitors actually are.

Major: Okay.

Darshan: Your second one is something I hinted at in this, which is understand what your end goal is. So what happens here is that you'll see a lot of companies going, "You know what? I want to have a clinical trial transparency strategy." That's great. That's smart. Here's the problem with that. If you don't know why you're doing it, you're going to have essentially a tail wagging the dog and you'll have to keep coming back and rechanging what you're doing. So we've had situations where clients will come in and say, "You know what? I want to have a global clinical trial strategy because we've made some commitments and we want to stick to those commitments." And that's important. We'll have some that say, "We are an extremely patient-centric organization, and we want to be forthcoming." We've had people talk about how patient advocate groups have called them out on it.

We've had situations where they are members of a global consortium like pharma or bio. And the implications of that are you need to follow the rules set forth by those organizations and therefore they need to follow that. So each of those and many of those and additional pieces may all play a role in what your end goal is.

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have Patrick Stone with us as always. He is our favorite ex-FDA auditor, who is always kind, always comes online and talks to us about his experiences at FDA investigating and auditing multiple sites, multiple sponsors and not multiple manufacturers.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast. With host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: Welcome Patrick, tell us more about yourself before we jump in.

Patrick: Sure. I was with FDM for 13 years. For the past nine years, almost 10 now, I've been assisting with the manufacturing of drugs, but lately I've been assisting more with the clinical research side, the good clinical practice side. And there's been a lot of new orphan drugs and fast track drug sponsors that have needed assistance. So that's typically where I'm at right now, assisting sponsors make their way to market, if everything looks safe and effective.

Darshan: Okay. We're talking about sponsors coming to market. We're talking about what steps they take. Here's my first question, Patrick, in these times of COVID, have things slowed down in sponsors bringing products to market?

Patrick: I think they have accelerated from my perspective, because what I'm seeing is more sponsors are coming to consultants like myself, to get things done in a different way. We can do more virtually, we're finding out for the past seven months, than we could traveling around chasing compliance per se. In my guesstimation, I would say there's more because there's two factors involved in that. One is, the FDA is a lot more collaborative these days, and they're providing a little more assistance and consulting in a certain way, not pure consulting, but they're not telling sponsors, "Look, you figure it out. We'll talk to you later," that's not their approach anymore.

Darshan: Okay.

Patrick: Their approach is, "Let's work on this. Let's see if we can get this done compliant," and they're in a little more collaborative vein per se. You see a lot more sponsors or a lot more organizations that are bringing products to market that, per se, would have taken a little longer or would have needed more money now because of the fast track and the abridging per se, we're not shortening things, but we're somewhat abridging them from an FDA review standpoint. It would make sense that you would see a flood of products trying to emerge in that type of setting.

Darshan: Before we talk about the quote unquote, abridging process, again, speaking as someone who follows the industry, who follows clinical research, do you think this is a result of the new FDA commissioner, or do you think this is just the direction the industry was headed and the FDA is finally accepting it?

Patrick: The commissioner has some parts to do with that. They're part of a cabinet and the cabinet direction stipulate some of this, but I think what we're seeing more of is the actual centers are opening up their avenues and they're really the ones that drive this, CDRE, CBRE, they're the driving forces for whether a product makes it or not, not necessarily the commissioner, the commissioner just gives them kind of a direction, but I think what we've seen in the last three to four years with the right to try, and would say even six to seven years ago, a little further than that, it seemed like the administrations are wanting the long process of approval to be abridged, to be shortened in the way that is safe and that we still follow the quality by design specifications that are laid out and in the 21 CFR.

Darshan: Quick question. And again, I have to admit,

Major: Hey guys, welcome to the DarshanTalks Podcast. Today, we're going to be talking about the six components of a clinical trial transparency program. My name is Major Hoffman and I'm here with Darshan Kulkarni.

Darshan: Yep. That's still my name.

Narrator: Good. Just double checking. This is the Darshan Talks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks, or the show's website at darshantalks.com.

Major: Darshan, can you briefly go over why you would need a clinical trial transparency program?

Darshan: So, one of the big reasons you want a clinical trial transparency program is because you're legally required to actually disclose... Components of having a clinical trial transparency program are legally required. So, if that's part of it, you might as well have a system around it, so that it's comprehensive, and you aren't trying to reinvent the wheel every single time. So, that's one big reason.

Another reason to do it is because it's the right thing to do. And you might want to do this because you're being a patient centric organization, and that's often the core values of a lot of different companies. And you might also be looking at having a clinical trial transparency program because it's trying to figure out how this fits into some of the other components that you're already managing. So, we can have a whole discussion about this, but those are some initial jump off considerations as to why [crosstalk 00:01:23].

Major: Right, I'm sure someone's like, we need to have a clinical trial transparency program, and I think in a previous discussion, you and I said or you mentioned this, this can be considered to be monolithic, and it doesn't have to be like that. And that's what we're trying to get into. Is theirs, out of all the different components or you've summarized those, or you've collectively put them in a list of six components of a clinical trial transparency program. So, without further ado, what is number one?

Darshan: So, the reason I mentioned a model, is most people think I want to have a clinical trial transparency program, and I have an answer to it. They think it's a question with a direct answer. Unfortunately, like we mentioned, there are at least six different components, and these six different components may have different answers. Each component may have a different answer than when compared to someone else. So, don't think of it as a monolith. Think of it as a jigsaw puzzle, and only you know what that final picture needs to look like.

So, the first component to that is a requirement if you are conducting studies, for example, in the U.S. or have U.S. implications, or using U.S. patients. You need to actually register your study depending on which type of study it is, under clinicaltrials.gov, which is the main website most companies use. So, it's clinicaltrials.gov. You also have the European version, which is EUDRACT, and that's E-U-D-R-A-CT. The EUDRACT website is not as active as the clinicaltrials.gov website. I think the last time I looked at it in one year, EUDRACT had something like 1500 studies and that same year clinicaltrials.gov had something like 19,000 studies.

Major: When you say clinical trial registration, do you mean registration of the clinical trial or clinical trial of participants in that clinical trial?

Darshan: So, what I'm talking about is the registration of the study that the study exists. So, this might actually be a tool for patients to register and say that I want to be part of the clinical trial, but this is not the place you'd go to, to register as a patient. It simply is where you go to, to say, I have a study. The second one is actually having a result.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks, or the show's website at darshantalks.com.

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have a crowd favorite with us today. We have Kelly Willenberg. And for those of you who don't remember, Kelly is the go-to expert as it relates to billing compliance, and in the context of helping develop a clinical research program. Most recently, Kelly got nominated to the board, I believe, of HCCA. Is that correct, Kelly?

Kelly: That's correct.

Darshan: And can you tell us a little bit more about yourself, and what is HCCA?

Kelly: So I am a nurse who has been in the research compliance industry since I started in 1984. So now everyone knows how old I am, which is kind of scary. But as a nurse, I came up through the ranks doing research, from being a research coordinator at a hospital taking care of sick and dying children on cancer studies, to helping the profession of healthcare compliance throughout the years and producing educational opportunities for people so they can learn about how to set up practices and how to do billing compliance right.

So as a nurse, I bring the medical knowledge that is needed to do that. But I mean, having the experience, I think, is a little bit different than some of the people that are out there that bring knowledge to the table. It's the fact that I've actually done almost every job in the healthcare industry around clinical research, having run a clinical research practice and large academic medical center.

And you ask about Health Care Compliance Association. So it is a organization that was established in 1996, that is a member-based association for healthcare compliance professionals. They do everything from conferences to publications, and a certification for healthcare compliance; healthcare research compliance and healthcare privacy compliance. And it's a way to stay connected with our peers across the world in compliance to help continuing education and develop better standards in a compliance program from across healthcare compliance to the society of ethics. So it's a healthcare compliance community that I bring my knowledge to the table to for the next three years as a board member.

Darshan: Well, they're going be really lucky to have you, is what I have to say about that.

So let's sort of jump into it a little bit, Kelly. So my first question is, in the context of clinical research, when does the average person approach you? When are they usually going, "I don't think I've got this figured out?" What is the thing that they haven't gotten figured out?

Kelly: Well, we have a lot of things that people bring to our attention, but I would tell you that a couple of the areas that we really do a lot of work in, and you and I have had a podcast in the past about, of course, clinical trial billing compliance. And when they find that they've got an issue, or they have questions about how that billing process goes, from the coverage analysis through the claims process.

But we also have a lot of clients that seek our help in establishing or reorganizing their clinical research office. And that can be rather challenging if you really don't have the knowledge or the bandwidth to actually know what you need in the form of a structure to actually go out and seek clinical research and bring it in to your facility, whether you're a practice or a small hospital facility that thinks that they want to do research.

Darshan: Now, in your experience, do you find more clients who are standalone small doctors offices calling out to you, or is it often large academic medical centers,

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have with us esteemed ethicist, world-renowned bioethics expert, Peter Koch. No relationship to the brothers. He's just extremely rich is what I gather. [inaudible 00:00:38]

Peter: Some big shoes to fill already, Darshan.

Darshan: No, Peter and I met and we've been talking about bioethics actually for several months at this point and he was kind enough to agree to jump onto the podcast and talk to us. We were discussing some different topics and he was telling me about topics he explores and the one thing that really popped... And there are two different topics we were considering. The one topic I'm really, really excited to explore is this bit of information around can I do clinical trials on patients after they've passed away? What rights do patients have after they've passed away? But before we get into that, Peter, do you want to introduce yourself to us?

Peter: Sure. Yeah. I'm an assistant professor of philosophy at Villanova University and my interests are really in clinical ethics, less on the research side, more on the decision-making, patient/physician/family interactions. I did my post-doc a few years ago in clinical ethics, so it's a pretty specific field in that sense. Generally I work in bioethics, some philosophy of medicine, which are questions of what counts as a disease, what counts as a disorder, et cetera. Yeah, so looking forward to being on your show.

Darshan: Thank you. So, let's start with the basics. If I am a patient and I agree to participate in a clinical trial and then I pass away, first of all, does my consent carry over?

Peter: Also to lay the groundwork, let's keep it all within an ethical framework because laws reflect different things in different places.

Darshan: Fair enough.

Peter: A good parallel is organ procurement because organ procurement of vital organs takes place after death. When we talk about whether or not we can take organs from someone or do things to someone after death, we're talking about a whole different set of what's at stake ethically from prior to death. Before somebody dies, one of the things that we're concerned about is their wellbeing, how this impacts how well their life goes. So that's how you get all these really fundamental ethical principles like do no harm. That's a claim about how we should treat patients and how we should maximize their wellbeing or at least promote their wellbeing without causing undue harm to them, which is essentially a drop off of wellbeing.

So that's a really fundamental way of approaching how we treat people and people can say, "Yeah, you can risk harming me as long as I consent." The typical consent framework is "I realize you're going to do something to me and my body, and I'm going to waive my typical right against someone doing that and now they're permitted to do it." So the interesting thing about after death is it raises a ton of philosophical questions about what does it mean to wrong someone after death? And even more problematically, what would it mean to harm someone after death? There's a lot of good, classic examples about this.

For example, if say, Darshan, you put together a really nice trust for future generations and you're like, "I want my grandkids to inherit X, Y, and Z or my kids." And so then you die and then your trust gets activated or executed, whatever you want to say, and we've totally misused and abused your trust. We don't use it in the way it was... And we slander your name, all these things.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have a very special guest. We have Donna Tobin, and Donna is someone I've known for several years, and she is what I refer to as the trademark lawyer extraordinaire. She has been someone I have reached out to for complex trademark type questions. She's going to talk to us a little bit about trademarking, because we've got a lot of questions that have been asked about, "Well, do I need to file for a trademark? How early should I file," et cetera. So, Donna, do you want to introduce yourself before we go on?

Donna: Sure. Thank you so much. Thank you for those really nice words. I have been practicing trademark litigation and prosecution, and prosecution means actually getting a trademark registered in the trademark office. I've been litigating them and prosecuting them for over 35 years. Hard to say without choking, but anyway, yeah, I've mostly practiced in the trademark arena my entire career, and a lot has changed, which I think will come up.

Darshan: I'm sure.

Donna: Yeah.

Darshan: So, where are you now, Donna? Are you on your own, or...

Donna: I am at a law firm that's based in Philadelphia, called Royer Cooper Cohen Braunfeld, mostly corporate M&A lawyers, and a year ago I brought a trademark group to them, because that's a practice that fits right in with what they're doing. A lot of their clients, once they have businesses that are up and running, one of the next things that you should think about is your brand, your trademark, and protecting that and enforcing it, and making sure that you're not stepping on anyone else's brand.

So, it's been great. It's a year old. Half of it was established in a pandemic. I hired trademark associates, two of which I haven't met in person yet, because they started the day we shut down. So, it's been interesting, but it's been great, and there was a little bit of a lull in March. People really were, for obvious reasons, taking a step back, but now people are thinking about their trademarks and their brands again, and it's kind of business as usual, which is good.

Darshan: So, that raises the really basic question, Donna. If a corporate group brings in a trademark group to help them, it sounds like they think that, and I know this from experience itself, there is significant crossover and the timing is right for those two groups to be working together.

So, this is a question I get asked all the time. "I have a great idea for a business. Should I first go after my trademark?" When do you think is the right time to apply for a trademark?

Donna: That's a great question, and I want to answer it by not answering that question first. I think it's important to just start out with, what's a trademark, what's a patent, what's a copyright, because often those things are all developed around the same time.

So, if you have a great idea for a business, let's say you're developing a new drug. There could be patents on the compounds, or on the method of manufacture. There could be copyrights on your text, your brochures, your graphic design. So, inventions are covered by patents, and then graphics, text, works of authorship, are protected by copyright.

Then there's trademarks, and either they all sort of happen at the same time, or the patentable invention comes first, and then, what are we going to call this thing, and that's the brand. A slogan, a logo, a name, a color, or even a smell or a sound, can function as trademarks.

Something that associates you as the source of a service or pr...

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks or the show's website at darshantalks.com.

Darshan: Hey everyone, welcome to DarshanTalks. We have Shannon Hartsfield with us and Shannon is a privacy attorney, but I wanted to let Shannon talk a little bit more about herself before we delve into some really interesting discussions around privacy and digital health and more. Shannon, could you tell us a little bit more about yourself?

Shannon: I'm Shannon Hartsfield. I'm a partner with Holland and Knight. I am based in Florida. I'm board certified in health law by the Florida bar. I've been practicing for about 25 years and I'm a co-author of a book that just came out in January, published by the American Bar Association called, HIPAA: A Practical Guide to the Privacy and Security of Health Data. Co-authored with June Sullivan who practices in Massachusetts. I'm excited to talk to you today.

Darshan: That's awesome. First of all, this may be the first time someone's actually plugged a book here so I love it.

Shannon: Have to get that in.

Darshan: That's awesome. I ended up writing a book as well for the ABA and I loved the process of it. I'm glad you've rewritten several. You've written this one for sure. And I got to make sure I get a copy and read into it and we'll probably have you back after I finish reading and I have questions. But here's a sort of jump off point for you because you can tell us a little bit more about HIPAA. When I go onto Twitter, when I talk to people, everyone's talking about how digital health is the new, well, it's really where everything's going. Whether you're talking about telemedicine, you're talking about FDA regulated apps, digital health becomes really critical. But then everyone says that HIPAA prevents us from really doing much. In your experience, is HIPPA everything that stops progress? What is your take on it?

Shannon: Actually, I think it's very rare that HIPPA is an impediment to anything that legitimate actors need to do with health data, with respect to treatment, payment and healthcare operations. As you probably know, HIPAA doesn't even require a patient's authorization in order for a covered entity, which are most healthcare providers and plans, to use and disclose protected health information or PHI for those purposes, treatment payment, healthcare operations. Now in the digital health era, it's interesting because people think that HIPAA applies to all health data. They kind of use the word HIPAA like we use the word Kleenex when we're talking about tissue. It's become sort of a generic moniker for all health data. But the reality is that a lot of times in the digital health world, HIPAA may not apply at all. For example, the health data that you collect on your personal devices or that you share with certain websites and things like that, may not be protected under HIPAA.

Now where we sometimes do see what I would call potential roadblocks in terms of sharing data, typically arises in state laws. State laws that were drafted long before digital health was contemplated in some cases, and those state laws are pretty short and sweet and say, "You can't share health information without the patient's authorization." Or, "You can only share it for treatment." Or something like that. And so these old state laws that don't fit really well with what we have today. On the other hand, HIPAA, the drafters of HIPPA thought long and hard about a lot of the common situations where we might need to disclose health data for public health, for example and all sorts of other types of uses. In the digital health era, one of the first questions you have to answer is does HIPAA eve...