Most in-house attorneys start their careers elsewhere and then end up on the corporate side.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Not Maggie Huston, who is an associate general counsel for Tempus, the precision medicine startup based in Chicago. Huston has spent her entire career in-house at healthtech companies, thereby witnessing the industry’s transformation over her 10-year career. That includes a stint as corporate counsel for Epic during the national implementation of meaningful use.
In a wide-ranging conversation, Huston addressed many topics including how Tempus quickly reacted to Covid-19 by introducing a test, and how a better balance between risk and reward can help to bring novel products more quickly into the marketplace.
This Q&A has been edited for length and clarity.
What is the most crucial issue facing health and life sciences lawyers, today, and how would you go about addressing it?
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
I feel very strongly that we need to find ways to bring new innovations into patient care as quickly as possible. The long lag we’ve historically seen between when we have good evidence for some sort of improved way for treating patients and when that innovation sees widespread adoption is just not acceptable.
Of course, we have to be careful, because bringing new technology into practice can pose real risks to patients, and we have to make sure we have got solid evidence of safety and effectiveness, but there can also be such a huge cost to delay. There are a lot of important factors we need to balance in healthcare. From a practical standpoint, we have to divide issues between those that need to be fully addressed before a product enters the market — what evidence and data do I need? What guardrails do I need to put into place so that the product can be used safely and without legal issues? — and those that can be addressed through post-market monitoring and iterative improvements.
Healthcare software is a great example of this issue from a policy perspective. At the Food and Drug Administration (FDA), there is a strong recognition that many of the traditional rules for regulating medical devices don’t make a lot of sense for today’s digital health tools. Compared to traditional medical devices, software iterates much more quickly, is tested differently, and generally has a different product life cycle. This is particularly true for artificial intelligence and machine learning software. We need to come up with different ways to regulate these products that provide similar assurance of safety and effectiveness but make more sense for that sort of technology and don’t unnecessarily delay them from being brought to market.
FDA is working on this issue — they’ve established a new Digital Health Center of Excellence, they’ve published a white paper on a potential framework for regulating AI/ML medical device software, and they’ve been running a digital health software pre-cert program to test out new ways of evaluating software. But we are still waiting on a final framework in this space and Congress may provide FDA with new authorities in this area. Hopefully, we’ll end up with a regulatory process that provides developers with more certainty, but also takes a risk-based approach that allows safe products to quickly enter the market.
What policy issues are you tracking?
I’m very interested to see how the new Office of the National Coordinator for Health Information Technology (ONC) information-blocking rule plays out. It was a long rulemaking process, but the final rule is quickly becoming a reality.
It is being rolled out in a phased approach, but some initial provisions go into effect April 5, and then additional work will happen through 2022. The healthcare industry will have to adapt, and it’s going to be a big change for providers in particular, who will have to get comfortable sharing more information with patients than some of them have historically.
At Tempus we are very philosophically aligned with the idea that patients and doctors should have access to their data, including things like lab reports that we generate, and be able to use it however they see fit. It will also be great to see more standardization around data exchange specifications, to help data move around more easily between different healthcare systems, such as between Electronic Health Record (EHR) companies and labs. It is a complicated project, but standardization will benefit everyone in the long term.
We also look forward to clarity from FDA on how we can incorporate real-world data and evidence into different regulatory processes to make sure we’re fully taking advantage of that resource. They’ve been working on it for a long time; it’s just hard. Real-world data is messy and has errors, so it’s a balancing act to make sure you use it in a responsible way.
In the precision medicine space, there are cases with rare cancer subtypes, for example, where finding a patient is like looking for a needle in a haystack. There’s a huge amount of potential to use real-world data to accelerate the development and approval process for targeted therapies that could really help people, so it will be great to see this policy area develop.
What legal industry trends have had the most positive impact on your practice since you started your career in-house?
I’ve spent my entire legal career — coming up on 10 years — working in-house for healthcare technology companies, so I’ve felt much more impacted by healthcare trends than legal industry trends. I was fortunate to be working for an EHR company during the height of meaningful use, when hospitals and clinics were rapidly moving to more sophisticated Health Information Technology (HIT).
Now, at Tempus, I feel like I have a front seat to watch precision medicine finally become a reality for patients. The number of targeted therapies that have become available for cancer patients and the impact of those therapies has been amazing to watch. I’m so thankful that I get to play a supporting role in this change through my work with our clinical sequencing lab and life sciences business.
What Covid-19-related change do you think will most impact health and life sciences legal practice, moving forward?
The past year has taught me a lot about the importance of being flexible and reacting with urgency to the circumstances around you. At the beginning of the pandemic, Tempus was mostly focused on next-generation sequencing in oncology, and we weren’t really doing anything in infectious disease. It would have been easy to decide that we had our hands full with our existing work and with the business continuity issues everyone was dealing with at the time.
Instead, we launched Covid PCR testing in our lab, and by the end of 2020 we had run over a million Covid tests. It meant a lot of fast decision-making in a difficult environment, where requirements were changing rapidly and there was a lot of uncertainty about the future, but I’m so proud of Tempus’ public health contribution during the pandemic. I hope I can continue to apply that sense of urgency and flexibility to my work beyond the pandemic.
It’s really easy for in-house lawyers to just be issue-spotters. Covid presented a lot of situations where we needed to look at a problem and say “there is no knowable answer to this right now, so we just have to make the best decision we can and go with it.”
In retrospect, a higher degree of certainty about the regulatory environment (or a crystal ball!) would have been fantastic, but everyone was doing their best under very difficult circumstances.
What do you wish you knew before you became an in-house healthcare lawyer
To succeed in this area, you need to have solid subject-matter expertise – it’s important to know HIPAA inside and out, understand the healthcare anti-corruption rules, etc. But it’s even more important that you develop the ability to exercise really good judgment and make decisions in an environment of uncertainty where you are balancing important considerations that pull you in different directions.
I’ve often seen the technology get ahead of the black letter law and in those situations, you have to be able to make decisions from a set of non-ideal options and do your best to find the right answer. It’s something that comes with experience.
I would go back and tell my younger self to worry less about always knowing the right answer and to spend more time talking to the smart people around me to understand how they solve hard problems and make decisions based on imperfect information.
What non-legal news sources do you rely on to understand the health and life sciences landscape?
GenomeWeb is a great source of industry news in the precision medicine space. Also, having spent many years in HIT, I still read HIStalk every week. It’s a great source of news about healthcare technology, particularly related to its practical use in hospitals and clinics.
If you could snap your fingers and have the general public understand one thing about health and life sciences, what would it be?
I’d want them to understand that healthcare issues are really hard. That’s not an excuse for all of the problems we experience when we interact with the healthcare system and the existing technology it uses, but it’s important to appreciate that healthcare is a much more complicated and high-risk environment than many of the other areas where we use technology.
That makes it extra important that we’re urgently looking for creative solutions to improve things, while also making sure new technology is incorporated in a responsible way. In my opinion, healthcare law is one of the hardest areas of practice because you’re dealing with human lives, and have a tremendous amount of responsibility to get it right.
What three titles would be on your Zoom bookshelf if you were interviewed by CNN?
I’m currently reading “The Doctors Blackwell,” about the first female MDs in the United States. I also recently finished “Rosalind Franklin: The Dark Lady of DNA,” which I really enjoyed. So there is a “women in science” theme for my bookshelf. I try to alternate between fiction and non-fiction, so my third book would be “A Children’s Bible,” by Lydia Millet, which was excellent, but perhaps a little too on point for 2020.
What would you have been if you weren’t a lawyer?
I wish I’d taken more science classes in college – maybe I would have gone in that direction, or to medical school. But in my current position, I get to spend a lot of time with brilliant scientists and doctors and support their work, so that’s a pretty good consolation prize!
