Drug and device research could benefit indirectly from the Trump administration’s plan to remove barriers to health data sharing that make it harder for patients to access their own electronic health records.
Two major health information technology proposed rules recently issued by the Department of Health and Human Services agencies aim to eliminate hurdles that currently prevent health data sharing between plans and providers as well as to spur ways to let patients access their health information via mobile devices.
The proposed rules focus on payers, information technology vendors, and providers. But they could complement Food and Drug Administration and National Institutes of Health initiatives that are high priorities for drug and device companies and researchers. Specifically, the FDA’s plan to use data sources from everyday life to help make drug and device approval decisions and the NIH’s initiative to promote targeted treatments known as precision medicine would benefit from the proposals.
“Both rules have the potential to have a positive impact on the ability to obtain data for research,” Deven McGraw, who’s the chief regulatory office for digital medical records platform Ciitizen, told Bloomberg Law.
“There’s absolutely nothing in either one of these rules that deals specifically with research,” she said. But what both rules do instead is to make it easier to share data.
Easing the flow of data among providers, insurers, and others means patients can more easily access their medical data and have a more complete record of their health. Those patients in turn might be eager to contribute that information to research, McGraw said.
Health IT rules
The HHS released the two rules Feb. 11, in concert with the Healthcare Information and Management Systems Society’s annual conference. The first proposed rule aims to stop information blocking, which is when a health-care provider or IT vendor interferes with the exchange of health information. This problem is well-recognized by the HHS Office of the National Coordinator for Health Information Technology, which issued the rule, and by lawmakers who required the regulation in the 21st Century Cures law (Pub. L. 114-255), designed to promote faster drug and device development.
The second proposal from the Centers for Medicare & Medicaid Services would require all Medicare and Medicaid managed care plans to create app-based systems that allow patients to access their records. It’s a push to get more health data into the hands of patients while increasing interoperability, or the ability of different electronic health systems to communicate and exchange data.
“Even though this is all coming out of ONC and CMS right now, I feel like it’s going to have a positive, downstream effect for NIH programs like All of Us and FDA and their real-world evidence programs,” Bray Patrick-Lake told Bloomberg Law. All of Us is the NIH’s precision medicine initiative. Patrick-Lake was a co-chair of an NIH advisory panel to establish All of Us.
Opportunity and Consternation
From EHRs to whole genome sequencing to insurance claims and wearables like the Apple smartwatch and FitBit, an explosive amount of health data are being generated.
“Clinical data has been and continues to be this source of incredible opportunity,” Jeff Smith, vice president of public policy for the American Medical Informatics Association, told Bloomberg Law. “The sheer volume of data that is going to be made available for a whole bunch of other purposes could be a boon to real-world evidence and real-world data without question.”
Clinical data also have been a source of consternation because they aren’t adequately standardized or available to support health-care decisions, Smith said.
Patrick-Lake has experienced this fragmentation first hand, both in work as the director of stakeholder engagement at the Duke Clinical Research Institute and in her personal life. After an immense effort to create a complete health record for herself, Patrick-Lake is still navigating six different patient portals, multiple binders, and stacks of discs. “I can’t do anything with it,” she said.
Aggregating patients’ health information is a critical first step in giving them a complete picture of their health, and they can then decide if and how they want to share it. This is especially important in the push toward precision medicine, which the NIH defines as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” The Cures law authorized almost $1.5 billion for the NIH to advance precision medicine.
“If we’re going to start preventing disease, we have to start looking at people’s health earlier, before an event occurs,” Patrick-Lake said. “And that has been a huge challenge because” patients’ health records are so fragmented.
The ONC and CMS proposed rules’ goal of making health data interoperable will help fill in those information gaps so disparate sources can be integrated.
Filling those data gaps will be critical for the FDA as it turns to real-world evidence because a more complete data set will lead to stronger evidence upon which the agency can make regulatory decisions.
“It just enhances the ability that the data will be available, and that it will be relevant and accurate,” McGraw said.
The FDA told Bloomberg Law in a statement, “Interoperability would help in utilizing and evaluating medical products in both pre- and post-market settings.”