By Komathi Stem, founder and CEO of monARC Bionetworks.
The FDA released guidance last year noting that electronic health records (EHRs) have the potential to improve clinical trials, leading to greater safety and efficacy. But tapping that potential, according to the agency, requires interoperability — the ability of two or more products, technologies or systems to 1) exchange information, and 2) to use the information that has been exchanged without special effort on the part of the user.
The healthcare industry, driven by meaningful-use requirements, is focused on wider efforts to promote interoperability. Many of them emphasize technology, including advances such as Fast Healthcare Interoperability Resources (FHIR) tools and Substitutable Medical Applications, Reusable Technologies (SMART) standards. But while the technology is crucial, it is equally as important to recognize the group of stakeholders who could play a critical role in making systems more interoperable, and thus improve the clinical trials process:
The patients themselves.
Interoperability has the potential to help increase care coordination, improve safety, support patients in making the most informed healthcare decisions, reduce costs, and help public health and health promotion efforts. In addition, interoperability can have a role in drug development, as the 21st Century Cures Act mandates that the FDA include Real-World Data (RWD) — data gathered during routine clinical care – in regulatory decision making. This RWD can be in part derived from the EHR-generated data, standardized and shared through the interoperability process.
The growing availability of information (digital health data is increasing by 48 percent each year) creates the potential for better patient care, including improved clinical trials. Unfortunately, despite strides made in interoperability, data in medical records are still too often packaged in ways (i.e., handwritten notes and medical device feeds) that are hard to share or standardized.