The Food and Drug Administration has issued a draft guidance stating that in order to see the highest success, clinical trial leaders must use electronic health records (EHR) that promote health data interoperability. In the draft guidance entitled Use of Electronic Health Record Data in Clinical Investigations, the FDA indicated that health data interoperability may be the key to enhancing clinical trials.
Obviously ensuring the clinical trial data is accurate and of the highest quality is something extremely important to the FDA as they use this data as part of its assessment for medications, treatments and drugs. The adoption of EHRs in healthcare and their potential reach are reasons the FDA believes they can help ensure the quality of clinical data.
The draft guidance, when finalized will represent the current thinking of the FDA and it provides recommendations on:
- Deciding whether and how to use EHRs as a source of data in clinical investigations
- Using EHRs that are interoperable with electronic systems supporting clinical investigations
- Ensuring the quality and the integrity of EHR data that are collected and used as electronic source datain clinical investigations
The FDA goes on to state that “EHRs may have the potential to provide clinical investigators and study personnel access to real-time and longitudinal health care data for review and can facilitate post-trial follow-up on patients to assess long-term safety and efficacy of medical products. There are also opportunities for long-term follow-up of large numbers of patients in studies where primary endpoints are rare, such as in prophylaxis studies,”
Clinical trial success heavily depends upon interoperable technology, and that includes interoperability between multiple EHRs to support better data transfer.
This is the second draft guidance issued by the FDA this year, in January they issued , Postmarket Management of Cybersecurity in Medical Devices, a draft guide on interoperability of medical devices.
The focus on interoperability in healthcare is a welcoming sight, but there is a lot of work that needs to be done in regards to defining interoperability and creating standards. It will be interesting to watch this all unfold.
