Healthcare Law

Episode 26: TLDR: A General Counsel’s Perspective on Digital Health

We are excited to announce a special series, TLDR. TLDR is focused on the digital health industry and the lawyers operating inside the companies innovating in the space, their work, the industry, and their experiences. In this episode of TLDR, my colleague Evan Hellman is joined by Michelle McGovern, General Counsel of Verana Health, to discuss issues associated with the current legal environment for telemedicine companies and the everyday hustle and bustle of a General Counsel.

Take it away Evan!

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Michelle McGovern is the General Counsel at Verana Health, which works with clinical databases in medicine to empower physicians and accelerate research for patients.

Michelle was previously the Deputy General Counsel at Redesign Health, a venture-backed incubator, during her tenure, built, launched, and scaled more than two dozen health care companies. Michelle also worked at Pfizer, where her roles included supporting clinical trials and pharmacovigilance, building sustainable markets for pharmaceutical products in the developing world, and serving as the North America Legal Lead for Upjohn, Pfizer’s legacy products and generics business.

Michelle completed Northwestern University’s accelerated journalism degree program, graduating in four years, magna cum laude, with a Bachelor’s of Science and Master’s of Science in Journalism, and received her JD, cum laude, from Northwestern University’s Pritzker School of Law. Michelle holds a Certified Information Privacy Manager credential from the International Association of Privacy Professionals, and she is the President of the Board of Directors of 826NYC, a charity that helps under-resourced youth build the skills to write their own paths forward, undefined by circumstance

Please note that the interview copy below is not verbatim. We do our best to provide you with a summary of what is covered during the show. Thank you for your consideration, and enjoy the show!

Evan Hellman

Thanks, Judy. Hi everyone. Evan Hellman here, senior Counsel at Foley and Lardner in our New York offices, and I’m joined today for the inaugural episode of TLDR, new podcast from the digital health team here at Foley. I’m here with Michelle McGovern, who is general counsel at Verana Health and a former colleague of mine and good friend. And we’re here to talk about just kind of general musings in the state of the digital health tech world, telemedicine, and what the experience has been of being a general counsel in that environment, where the industry is going, and the kind of interesting points that we see coming along the way. Hi Michelle.

Michelle McGovern

Hi Evan. Thank you for having me.

Evan Hellman

So jumping right in to our conversation, you’ve kind of run the gamut in terms of your experience in the legal profession. You’ve been at law firms, big law, you’ve been at major multinational corporations. You were at Pfizer and their subsidiary GreenStone, if I’m not mistaken?

Michelle McGovern

Yes, I was at Upjohn.

Evan Hellman

Upjohn, excuse me.

Michelle McGovern

Yes. But GreenStone was one of my clients, the generics business.

Evan Hellman

And then you’ve been in the health tech startup world for a number of years now, and you currently are general counsel at of Verana Health, which is a late stage company as well. And so my first question for you is, having had all your experiences and now being in the general council role, what do you find most gratifying about that role?

Michelle McGovern

What I love about the general council role is at the end of the day, the buck stops with you. So I guess the downside is, the buck stops with you, but you get to own every single one of your decisions and it’s really gratifying to be able to make that market assessment, take a look at what’s going on around you, and then advise your executives yourself. I think that’s what you’re leading up to when you’re building your career. You look at each step as, I’m learning something that I’m going to give to someone else later. And when you’re in the GC seat, you really get to do that in real time. It’s really fun.

Evan Hellman

And any of your experiences kind of prepared you for that as you’ve gone, and I know you’ve been at it for a while now, so this isn’t like a first rodeo for you. But along the way, in your various iterations of the legal profession, was there a formative experience that you said, okay, I know I can do this now?

Michelle McGovern

I think it’s a great question actually. I would say that I was at Redesign Health, which is a startup incubator during the COVID pandemic. So at the time there were roughly 12 operating companies. I was a deputy general counsel at Redesign, we were working in real time to how to address the pandemic, how to figure out how to deal with your workforces.

And being able to work with so many different companies, literally you don’t have the information that you need to make an informed decision because the entire world doesn’t have that much information. And you really learn to develop your judgment, trust yourself, and to sort of synthesize all of the things that you’ve been working on your entire career. Being able to lead companies through that time in such a high stress environment globally, really made me feel comfortable that I would be able to do that anywhere and for anyone.

Evan Hellman

I know that the teams here and everywhere, and in my experience in-house before coming back to private practice weathering the pandemic and COVID-19, and basically the see changes that we saw in the health care industry, particularly in digital health, both created a number of years where just the work environment and the regulatory environment was something that I don’t think we’ll probably ever see again in our lifetimes.

Michelle McGovern

I hope not.

Evan Hellman

I hope not. I hope not. So there was certainly that, but I do think that it was also very much to your point, like a trial by fire in the most explicit way, in that if you can handle your clients and the advice you’re giving through that experience, there’s pretty much nothing else you can’t do. So I certainly agree with that. On that note, coming off of we are ending the public health emergency as well, in terms of challenges that you come across functioning as a general counsel, as a top legal executive, is there anything that sticks out in your mind in terms of… We’ll frame it this way, if someone else came to you and said, I want to be a general counsel, what’s the one piece of advice that you would give would give to them if they’re looking to that role?

Michelle McGovern

I think that’s a great question. The thing about being a general counsel is you have to make sure that when somebody comes to you, you have to treat their problem as if it is the COVID-19 emergency for them. And I think that being a good GC is that you’re constantly in the back of your mind thinking about all the other confidential things that not every single person who comes to you knows about. But that when I get a question from somebody, whether it’s the most junior person on our clinical trials team or my CHRO who works on health care or who works on human resources, their problems are all the same. When I respond, it’s with the same level of seriousness, thoughtfulness, I take into account all of the externalities, no matter how big or small it actually is, but it’s your job as GC to make sure that people feel that they are being supported at every level and really to meet them where they are.

Evan Hellman

So the public health emergency is ending May 11th, life is getting back to normal. But what’s really interesting is I think if we look back pre-pandemic and in the digital health space, the environment on fundraising was very robust and there were lots of companies coming out. I think what’s also really interesting there in the digital health space is that the pandemic has also, in my view, certainly made the case for telemedicine and digital health companies to say, we can provide really good services that are appropriate and medically necessary and really are helping people. And I would imagine we may see an upswing in continued growth in this industry. Where do you see the future of digital health going? Is it going to be more direct to consumer? Is it going to be moving into utilizing value-based care and leveraging payer relationships now? Where do you think this is going to go?

Michelle McGovern

Well I have an answer. I want to hear what you think though, because you’re seeing this all day long.

Evan Hellman

There is currently a natural evolution to the industry and a number of years ago, it was in its more nascent stages and you had more direct consumer activity, more cash-based models. There were models and structures that were just feeling their way forward and saying, is this possible? Is there a viable market here? I think that’s been pretty much proven. And now I think that companies here are beginning to mature in a way that, I wouldn’t say that institutional providers have always, where they sit in terms of working with payers and different kinds of reimbursement models. But I think that generally we see that the market is increasingly, it’s expanding in that it’s now kind of saying, okay, we haven’t dipped our toe into insurance reimbursement. So there’s a huge beneficiary marketplace out there that is untapped right now by part of the industry, let’s see what we can do with that. So I think that there is something of that natural progression that’s going to occur. That’s my thought as the industry continues to evolve.

Michelle McGovern

No, I think that’s right. I think lowering the cost of care in general is going to be a trend because that’s what HMOs were back in the day. I think value-based care is not new and effectuating it is what’s going to be where we iterate, not a question of how are you getting good care for your money? It’s a question of what is the way we are best able to deliver better care for less money? So I’ve been, as you mentioned, I’ve been a health care lawyer for a very long time. So we’ve seen trends in preventing hospital readmissions or implementing care coordinators. All of the things that I think I was working on when I was a junior lawyer before tech was such a big player in the industry, you see tech enabling in ways that are just almost unprecedented. Being able to track and monitor and link up different provider groups and networks and link them to one individual person.

I think care coordination is fascinating in its ability to drive down costs, and tech just makes that easier and better. So I do think that we’re going to see tech used in ways that will make costs less for individuals. I think that’s going to be where tech really is a game changer. I’m also a massive user of health care services. I have three young children, for those who are listening. But every time one of my kids is, the first thing you do is you set up a video visit, somebody recommended an online pediatrician where they send you a scope and they can diagnose any ear infection online, which I think everyone should know about it.

Evan Hellman

Yeah, yeah, I’m taking notes.

Michelle McGovern

Yeah, yeah, I’ll send that one around later. But those are things that tech really, there’s a cost containment, but there’s a convenience model that I think tech is really bearing out, especially for younger generations. There are some people, sometimes myself included, I guess I’m the oldest millennial, I still love to go to a doctor. It’s part of the experience for me. But there are so many people for whom that is not even their base case. And that’s where I see I think trends are really going to be making the DTC, the direct-to-consumer experience, more seamless, more comfortable, and maybe creating that hybrid model where your provider or someone you get to stay with your whole life, even if you’ve never met them live.

Evan Hellman

One trend that we are also seeing a little bit more as well is taking that tech, taking that innovation, but having it in some ways return to more established models and having a click and mortar model where you have that [inaudible 00:11:10]… I did not come up with that.

Michelle McGovern

I’m going to pretend that I did that.

Evan Hellman:

But basically to say that, you might have that first online initial visit with a provider, maybe even going as so far as having that peripheral kind of device or something like that where someone allows you to scope something at home, which would be really interesting. But then eventually, you do that first tron shows kind of interaction. But then do you then go back into the office for an in-person visit for more involved workup that may be occurring, but it’s to enhance the tech that’s there. But until something can be completely virtual and really be able to lay hands on, there’s always going to be that kind of need to go in and see people.

Michelle McGovern

Well, I think what tech allows providers and practitioners to do is really meet people where they are. And I think that that’s what really unique about it. It does bring the level of care that you can intake at the time to you, whether you go from there and establish a face-to-face relationship is really up to you. But I think tech lowers the barrier to entry, I think, to health care for so many people. And I think that’s what’s really exciting about working in health tech. You get to be part of that first entry point. So I think most people become health care… I work in health care services.

I consider health care law, health care services, and being part of what brings health care to the masses is really important to me. That’s why I get out of bed every morning. I get to help people have a better experience every single day when they get health care. And for me, being able to bring point of care to your home, that’s a huge, huge boon I’d say. And something that I don’t think I even dreamed of when I started practicing and in the stone-age. I started practicing in the stone-age. I think I had a Blackberry. A Blackberry kids, is a tiny little… I’m kidding.

Evan Hellman

So yes, I think to your point, allowing tech to meet people more so where they are and to enhance the experiences. In terms of, we were actually talking about it earlier today with the overlay of you’re in the health care space, one of the most highly regulated industries out there as the top legal executive individual at your current company or at any other company or just in the space in terms of your, what you’re seeing in terms of the need to how you counsel people. And when they come up with this moonshot idea that they really believe in and they want, what’s the conversation? I think that for most general counsels coming back and saying, no immediately is a death knell. You’re not going to survive very long if that’s your approach. Talk a little bit about, if you could, your style in terms of being solution oriented or how you work through a problem with somebody. Again, take the example of a fairly senior person comes to you with maybe what you would think of as something of a moonshot or this isn’t going to work. How do you talk to them about it?

Michelle McGovern

So a lot of times when someone comes to me with a crazy idea or a moonshot idea, I have to remember that I am working every day in a company that dared to think that big. And you have to understand that, well, the laws that regulate these industries, they’re extraordinarily important. I’ve worked in this space my entire life. It’s important to make sure that everybody’s privacy is protected. It’s important to make sure that we are using government funding to the extent of things Medicare or Medicaid covered. We have to make sure that we’re being responsible with government funding, but we also have to think about the power of innovation and the possibility that innovation has to bring down costs of care, to bring treatments to people. And when somebody comes to you with a moonshot, I think, okay, so the laws that exist maybe didn’t exactly consider this hypothetical, how do we apply that anyway?

You can’t wait until the law catches up to your business, not if you’re in digital health. And you have to be willing to say not no, because this hasn’t been contemplated, but let’s think about how this regulatory environment applies to this fact pattern, even if this fact pattern didn’t exist. And I think that I find that very exciting. But I also think that, and I’ve been in the digital health industry now for a number of years. People I think often have a view of large company lawyers. I was at Pfizer, as you said, for a number of years. Pfizer isn’t a company that thinks small either. And I think that there is this sort of false assumption that lawyers at big companies, whether it’s health care companies or hospitals, health systems or pharmaceutical companies, are risk averse or slow. Pfizer brought a vaccine to market in a year.

That’s incredible. It’s unprecedented. And I think that the skillset that you learn in health tech and in digital health really serves you no matter where you are. And it’s really not a question of, okay, how do you look at things through a health tech lens? But as lawyers, are we prepared to meet the challenges that our businesses present to us? And are we going to be nimble enough to keep pace? Just because we’re rooted in law doesn’t mean we have to be 20 years back. And I think that there is this, HIPAA is not the newest regulatory scheme, but it’s something that we have to continue to reinterpret to apply it to new fact patterns every single day. Our job to make sure that we’re staying current and not that we’re saying no because something wasn’t contemplated.

Evan Hellman

Yeah. One topic you alluded to earlier, which I think is important as well, again, in-house, because as you said, the health tech industry moves incredibly quickly. Client demands are quite, just the pace is to be reckoned with for sure. But that’s also partly what’s really exciting. And there’s never a boring day and questions come fast and furious. You know, do mention you’ve got young children, you’ve got three young kids. And what’s that experience been like? I remember when you were having your twins, you were still in-house at Redesign and you were going from one to three very quickly, obviously, and I’ve got two young girls myself, and so obviously everyone in any industry, any business, it’s a constant balancing act.

But I think it’s also really interesting when you are not just filling a high level executive role as a general counsel, but you’re also setting an example for younger employees, whether they’re in legal or not. When I had a staff of lawyers in my shop, I do remember that most of the lawyers did have kids, and it was a really nice environment in that way because we all knew we were kind of in the same boat in some ways. How have you personally dealt with that? And then to the extent that you’ve got young parents out there as well with meeting the demands of everything, because it doesn’t mean that things slow down, everything keeps going.

Michelle McGovern

No, so I have a seven-year-old son, Gabriel, and I have twin daughters, Fiona and Violet, they’re almost three. So they were actually born in May of 2020. So just for everyone to think about that, I was in the middle of really advising a number of baby health care companies, early stage pre-Series A seed level health care companies. And I was very close to being the mother of three children, two of whom were going to be born in May of 2020. So part of what’s really great about kids is it gives you purpose and keeps you grounded, and it reminds you that you’re working not just for yourself or for the companies that you’re advising, but you’re working for all of these people who are going to benefit from the technologies and the ideas that you’re helping to foster as a lawyer. So I do think kids give me, and I hope they give you and other parents a sense of, why am I doing this?

Otherwise, I would just go… I don’t know what I would do. But health care to me always feels very pressing when I think about my children. It’s really hard. It’s really hard to be a working parent. I wish I had a really great secret.

Evan Hellman

But you’re going to solve this right now.

Michelle McGovern

It would be remiss not to mention my husband. I do think having a partner who is willing to, or happy to, maybe the better way to say it, share the burden of pickups and incredibly esoteric holidays, which we get off now. So some of it’s just really creative juggling with helpful people, but I also think that as you become more senior, it is your job honestly, to show not just your team, but the people around you that it’s okay to be a parent.

I think it’s okay to say, although if you saw me, I look very young, but I’m a middle-aged woman, and I think that the years that mothers in particular, I can only speak for myself as a mother, but I will expand it a little bit. The years that mothers are parenting young children often are really critical years in your career as well. I am really lucky, I had an extraordinary, I still have an extraordinary mentor. We no longer work in the same place, but at Pfizer, my mentor just made sure to pull me up every single day and really help me succeed as a mother at the time of a very young child in a new role and taking on massive responsibility. And I think that supporting parents during this time, allowing them to stretch themselves as much as they want, but also giving them space to parent as well.

The dividends that pays off in people’s later careers is, I think it’s hard to calculate. So part of what I try to do every day is make sure that I am allowing the parents on my team to grow and to learn and to do whatever they want to do, and not to hold them back because I think that’s what they need, but also to be really supportive when they have a daytime commitment that they absolutely cannot cancel. The other thing that I think is important as a parent is to remember that children are not the only thing that matter to people. And I also tell members of my team who aren’t parents that their yoga class is important, their darts game is important, their pet veterinarian appointment is important, their parents are important, their friends are important. So I also think being a parent has sort of expanded my compassion in the workplace, and it’s really important for us to back each other up no matter what our evening commitments are.

So I think that that’s sort of the challenge to everybody is, yes, my kids cannot walk themselves home from daycare, but that doesn’t mean that I should always get the priority in the evening, and that if somebody else has an evening commitment, they should have that honored as well, even if that’s not about a kid. Again, I’ve been lucky in that my executive team at Verana and the folks I worked with all of my career have been very supportive of my stance on people’s private lives, but happy people are happy employees, and I think that really does create a really special workplace alchemy that that’s part of the culture I want to build as a GC.

Evan Hellman

Yeah, no, I think that being in the GC role has tremendous amount of benefits, and there are obviously stressors like many other jobs as well, but certainly being able to lead a team and a department, but also, you are coming at it as a trusted counselor and advisor. And so what’s interesting, and the reason why I partly asked that question about parenting in your personal life a little bit is more because people will look to you for issues that you didn’t expect to walk in the door and deal with them. You’re not looking at a regulation every day, you’re not reading a statute, a lot of it can be soft questions, and how do I approach? I remember having discussions with other executives on the team to say, how do I approach this conversation with a more junior staff member? Because you are seen as not just a legal professional, but a true counselor in many ways, somebody to confide in and to have that role. So taking that holistic approach is important to the job for sure.

Michelle McGovern

Well, what was it like for you, you were also a parent of young children doing the COVID-19 pandemic in a GC role. How did you do it?

Evan Hellman

I think that also having a partner who essentially saved me basically, my wife. It just simply put, was getting comfortable with the impossible task and that it was not going to work out the way you wanted it to and to be okay with that. And I think one thing, just as I reflect on that experience and going forward on things now, it’s just trying to be as hyper focused and present when you need to be in the sense that when you’re with your family and your personal life or at your vet visit or at your yoga class, or with friends, being present, being in the moment trying to commit to that. And then when you’re sitting in front of your desk and you’re working and you’re doing climate matters and you’re answering questions, just being as hyper-focused on that as you possibly can to just make sure you’re as efficient and get through everything and the balance generally will come, I’ve found.

I think part of the danger is when you are trying to do a little bit of this, trying to do a little bit of that, and then nothing gets done fully, is the danger zone. That’s probably what I saw and as I reflected on it, but also I think it’s just generally a function of being okay with recognizing that there’s going to be some give and take on a situation. Much like giving advice, in the sense that if you have a question that gets posed to you by your clients, it’s recognizing that A, sometimes there’s obviously very much not a clear cut answer. That’s pretty table stakes on certain issues and getting comfortable with that and trying to advise accordingly.

You mentioned that when laws haven’t caught up to certain situations that we’re dealing with, but getting comfortable with that, but also just allowing yourself to be flexible and making the logical analysis and being confident in that. I think one thing that can be really, not harmful, but doesn’t help move the ball forward with lots of stakeholders is when you don’t feel confident in what you’re doing. And so there’s always potentially a ability to revisit or to kind of do some further analysis, but generally the analysis is logical, it’s measured and you’re confident about it. That definitely impacts how you give advice.

Michelle McGovern

As you were saying this, I was thinking, I rarely say no. It’s always easy to say no at work because it’s the least risky. I’m often trying to find the path to a yes for a client and to help them sort operationally how they’re going to get to their goals. And I think my husband would say that I also don’t say no enough at home. So maybe it’s not a question of how do I balance the two, but really what am I bringing from work right back home? There was a donut this morning that was absolutely unauthorized, but it was leftover from Easter and we’re just going to roll with it. So I do think that drawing the boundaries between work at home can be important when you’re really comfortable helping advise people and helping them meet their goals. Sometimes you do need to bring home a little bit more rigor with the no’s than maybe you show up with at work. There’s not always a path to a donut. But at home sometimes there’s a path to a donut.

Evan Hellman

So yes. No, agreed. Well, Michelle, thank you so much for joining me on the inaugural episode of TLDR. It was wonderful to talk with you and see you as always. And I think really interesting insights on the GC role, your experience, where you think the health tech industry is going. Again, thank you very much for coming in and joining me on the episode.

Michelle McGovern

Thank you for having me, Evan, and thank you very much to Foley for all of your expert advice and counsel.

Evan Hellman

Thank you. And now back to you Judy.

 

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