Nadine Peters moved from Partner at Hogan Lovells and Verrill Dana to Counsel at HHS and PCORI to Chief Legal Officer at COTA Inc., a data startup founded by oncologists that aims to bring clarity to cancer treatment through the use of real data. Her experience advising regulators and clients on everything from medical device reimbursements to data protection protocols has given her a unique perspective on how policies can promote patient-centric, equitable, and value-driven innovation in healthcare. We sat down and received Nadine’s perspective on where the regulation of health data should and should go.
This interview has been edited for length and clarity.
How do you manage the regulatory burdens related to data protection and data sharing when fulfilling COTA’s mission?
Some of these things would be daunting if I weren’t 100% familiar with HIPAA and couldn’t tell you which subsection of the privacy rule says what. While in private practice, I also received informal guidance from regulators to help me keep my finger on the pulse of how they think about these things and understand – and they will admit – it’s HIPAA There’s a lot that isn’t designed for what data – sharing looks like it does today and uses applications that weren’t considered then in terms of the way technology now allows you to link and identify data .
We are a business partner within the framework of HIPAA because we have provider and payer customers who entrust us with their data. We also license unidentified data to life science companies subject to FDA regulation and hope to use this data for regulatory filing.
To a great extent, we can rely on the safe haven, which is a unique way of using data as per the HIPAA privacy rule. For projects with a very small cohort, e.g. However, if you have a rare disease, for example, it is important to use the expert investigation method, where someone performs a risk identification analysis to determine which items of data need to be changed to make it difficult to identify an individual patient.
COTA attempts to conduct this analysis before we promise to fulfill a request for an outcome that contains data items that are traditionally not included in the unidentified Safe Harbor dataset, such as: B. a full treatment date versus deltas or the quarter in which someone was treated.
And while HIPAA is the standard in the US, healthcare attorneys also always observe data standards for genetic material – we can remove identifiers, but is the genetic material itself considered identifiable?
Beyond HIPAA, we take our regulatory responsibilities in the area of information security and data protection very seriously. We ensure that our contracts have the rights we need for an efficient analysis, but then only use the data for the purposes described in our business model. And we return and destroy all data upon identification.
What key points on the health policy agenda would you ask Biden to address if given the chance?
The first is to improve health care disparities by not only improving access to health care but also ensuring that the development of new therapies and treatments takes into account the different ethnic backgrounds that drive health outcomes contributes. It starts with something that COTA is involved in: making sure these people are involved in research and development.
With COVID, we have had discussions about the different effects on minority communities and who is involved in these vaccine clinical trials and the rhetoric surrounding the suspicion of medicine in minority communities.
Data has an answer to many of these problems.
What COTA has been able to show is that when you have real data access as a control arm or a non-placebo arm, it shows the standard of care in how to treat a particular person with cancer like multiple myeloma. This helps inform research in ways that gold standard randomized clinical trials (RCTs) cannot achieve, as there are barriers to entry beyond cultural distrust. For example, there are people who cannot travel to study locations because they are usually very centralized.
Real-world data not only helps diversify research in drug development, it also helps identify real differences in care. COTA has studied the incidence of multiple myeloma in black populations and the time to first line of therapy and the rate of stem cell transplants. The inequality, the time lag that is needed for someone not first diagnosed with multiple myeloma, the black versus white when treated, isn’t obvious unless you look over cohorts and people with the same tumor types and ask “When was the first time you were offered this care?”
I think that helps you see what this government is seeing: “Where is there structural racism? Where is there an opportunity to develop an anti-racist policy? “Without data, we cannot make a strong case for initiating new policies, so I feel really blessed to be in a company that is in the middle of this.
What I am aiming for is that there are some clear guidelines and standards in place to ensure that the regulatory data is consistent, that we can all play from the same game book and see what the FDA is relying on for safety and effectiveness decisions.
I also think the HHS Civil Rights Bureau should take a close look at data sharing and see where there is a way to improve the usability of data while protecting patient privacy.
A big, important goal of this is to make sure that patients understand the value of their data and that there is a way to use it without causing harm or risk to them.
People want to contribute. Often times, when they understand the value of their contribution, patients are genuinely willing to do so because they want to pay it forward and help develop treatments that could help someone else with their disease.
In light of this, I think there needs to be an awareness campaign about how research is done and what goes into drug approval. You see a lot of skepticism about vaccine safety, but if you really understand what it takes to get a drug approved, I think you need to have a little more faith in the system as the standards are pretty strict and a lot of time in Build up the amount of data required to demonstrate safety and effectiveness.
Can you talk about how better use of patient data is affecting health care costs?
At COTA, we want to improve the way oncology care is reimbursed by providing the analytical kits that payers need to better support value-based care and reimbursement practices for care.
While serving in the HHS Office for General Counsel in Medicare Coverage and Reimbursement, I advised the agency on what was appropriate and necessary based on evidence for new medical devices and new treatments, and what was appropriate for Medicare. Population should be covered. COTA has the ability to provide meaningful data on what is appropriate and necessary when it comes to value-based care in oncology.
What three books are on your Zoom bookshelf when you are interviewed by CNN?
So the first is The Codebreaker by Walter Isaacson. It’s about Jennifer Doudna who developed CRISPR genetic engineering – I think that was a major breakthrough in terms of delivering precision medicine. Then Black Man in a white coat from Damon Tweedy, a doctor who attended Duke Medical School, and his experience of navigating medicine, both as a doctor and a patient. Finally, Blue Ocean Strategy, which our CEO Michael Doyle recommended because it gave me perspective in an area where I need growth. I was a bio major and then studied law. I have never had management and business courses and had to think about these topics that way. Now that I’m in that area in this company, I’ve really gotten into that kind of thinking.