Home Health Care Using data for anti-racist medical research: An interview with COTA’s chief legal...

Using data for anti-racist medical research: An interview with COTA’s chief legal officer

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Nadine Peters has gone from Partner at Hogan Lovells and Verrill Dana to Counsel at HHS and PCORI to chief legal officer at COTA Inc., an oncologist-founded data startup seeking to bring clarity to cancer care by leveraging real-world data. Her experience counseling regulators and clients on everything from medical device reimbursement to data privacy protocols has given her a unique lens on how policy can nurture patient-centered, equitable and value-driven healthcare innovation. We sat down and got Nadine’s perspective on where health data regulation is — and should be — headed.

This interview has been edited for length and clarity.

How do you navigate the regulatory burdens surrounding privacy and data-sharing as you fulfill COTA’s mission?

Some of those things would be daunting if I wasn’t 100% conversant in HIPAA and couldn’t tell you what subsection of the Privacy Rule says what. While I was in private practice, I also got informal guidance from regulators that helped me get my finger on the pulse of how they think about these things, understanding — and they will admit — that there’s much in HIPAA that was not drafted for what data-sharing looks like now and uses that weren’t contemplated then in terms of ways technology now allows you to link and identify data.

We are a business associate under HIPAA, given that we have provider and payer customers that entrust us with their data. Also, we license de-identified data to life sciences companies who are subject to FDA regulation and are hoping to utilize that data in regulatory submission.

To a large extent, we can rely on the safe harbor, which is a clear way of using data as specified in the HIPAA Privacy Rule, but for projects where you have a very small cohort, such as for a rare disease, it’s important to use the expert determination method, where you have someone do a risk identification analysis to determine what data elements we need to consider changing to make it harder to identify an individual patient.

COTA looks to perform this analysis before we promise to fulfill a request for a deliverable that includes data elements that are not traditionally in the safe harbor de-identified data set, like a full date of treatment as opposed to deltas or the quarter in which someone was treated.

And while HIPAA is the standard in the US, healthcare lawyers are also always watching data standards for genetic material — we can remove identifiers but is the genetic material itself considered identifiable?

Beyond HIPAA, we take our regulatory responsibilities very seriously, both from an information security and data privacy side. We ensure our contracts have the rights that we need to do analyses efficiently but then are not using the data for anything other than what is outlined in our business model. And we return and destroy all data upon de-identification.

What top health policy agenda items would you ask Biden to address, if you had the chance?

The first one is to improve disparities in health care by not only improving access to care, but ensuring that new therapies and treatments being developed take into account the different genetic makeup across ethnicities that contribute to health outcomes. That starts with something COTA is involved in: ensuring that those people are included in research and development.

With COVID, we’ve had discussions of the disparate impact on minority communities, and who’s involved in those clinical trials for vaccines and the rhetoric around distrust of medicine in minority communities.

Data has an answer to a lot of these issues.

What COTA has been able to show is that when you have access to real-world data as the control arm or non-placebo arm, it shows standard of care of how a particular person with cancer, like multiple myeloma, is being treated. That helps inform research in a way that you can’t get with gold-standard randomized clinical trials (RCTs) because there are barriers to access beyond cultural distrust; for example there are people who can’t travel to study sites because they’re usually very centralized.

In addition to helping diversify research in drug development, real-world data helps to identify real disparities in care. COTA has looked at incidence of multiple myeloma in Black populations and time to first line of therapy and the rate of stem cell transplants. The disparity, that time lag it takes for someone who’s not first diagnosed with multiple myeloma, who’s Black versus white, in terms of when they get treatment, isn’t apparent unless you look across cohorts and people who have the same tumor types and ask “when were they first offered this care?”

I think that helps you identify what this administration is looking at, which is “where is there structural racism? Where is there the opportunity to develop anti-racist policy?” Without data, we cannot make a strong argument for initiating new policies and so I feel really blessed to be at a company that is right in the middle of this.

What I am striving for is that there be some clear guidance and standards for ensuring that there’s consistency across regulatory data, that we are all playing from the same playbook and can see what FDA is relying on for purposes of safety and effectiveness decisions.

I also think the HHS Office for Civil Rights should take a hard look at data sharing and see where there’s a way to improve usability of data while still protecting patient privacy.

A big, important objective under that is to make sure patients understand the value in their data, and that there is a way to use it without creating any harm or risk to them.

People want to contribute. If they understand the value of their contribution, a lot of times patients are really willing to do that because they want to pay it forward and help develop treatments that could help someone else who has their condition.

Given that, I think there needs to be an education campaign around how research is done and what goes into a drug approval. You see a lot of skepticism around vaccine safety, but if you really understand what is required to get a drug approved, I think you have to have a little more confidence in the system because the standards are quite rigorous and it takes a lot of time to build up the amount of data that’s needed to demonstrate safety and efficacy.

Can you speak to how better use of patient data impacts the cost of healthcare?

At COTA, we seek to improve the way oncology care is reimbursed by providing the analytic sets payers need to better support value-based care and care reimbursement methodologies.

When I served at HHS Office of General Counsel in the Medicare Coverage and Reimbursement Division, I advised the agency on what was reasonable and necessary based on evidence of new medical devices and new treatments and what should be covered for the Medicare population. COTA has the opportunity to provide meaningful data for what is reasonable and necessary as value-based care comes to oncology.

What three books are on your Zoom bookshelf if you’re being interviewed by CNN?

So the first is The Codebreaker by Walter Isaacson. It’s about Jennifer Doudna who developed the CRISPR Gene technology — I think that has been such a seminal breakthrough in terms of how we deliver precision medicine. Then Black Man in a White Coat by Damon Tweedy, a doctor who went to Duke Medical School, and his experience with navigating race in medicine, both as a doctor and patient. Finally, Blue Ocean Strategy, which our CEO Michael Doyle recommended, because it gave me perspective into an area where I need growth. I was a bio major and then went to law school, I’ve never had the management and business kind of courses and had to think about those issues in that way and now being in this company in this space, I’ve really gotten interested in this sort of thinking.

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