We are very excited to see that the FDA has just released a draft guidance that consists of non-binding recommendations regarding the Use of Electronic Health Record (EHR) Data in Clinical Investigations. EHR may include patient specific data such as medical history, prior and current diagnoses, treatment plans, immunization records, pharmacy records, and various medical test or lab results.
The guidance document provided recommendations on:
- 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 data in clinical investigations, and
- ensuring the use of EHR data meets FDA inspection, recordkeeping and record retention requirements.
Although this description does not establish legally enforceable responsibilities, it indicates that the organizations are preparing for an increase in the usage of EHRs and electronic systems supporting clinical investigations. The guidance document has highlighted some of the potential uses and benefits of integrating EHR into clinical investigations, including “access to real-time and longitudinal health care data for review” and the facilitation of “post-trial follow-up on patients to assess long-term safety and efficacy of medical products.”
The concept of full interoperability between EHR and Electronic Data Capture (EDC) systems is discussed and promoted as having the potential to “reduce errors in data transcription and provide data that is more accurate and complete allowing for improvement in the quality of clinical investigations and the interpretation of data.” The general assessment is that EHRs have the ability to improve multiple facets of the scientific medical process, including improvement in patient safety, data accuracy, and overall clinical trial efficiency.
While EHR systems, in general, are not considered FDA-regulated entities, when utilized as a data source for clinical trials, they should be ready for FDA on-site inspections and audits. The document makes note that EHR data should be “attributable, legible, contemporaneous, original, and accurate” following ALCOApolicy. The guide also provided best practices policy recommendations in regards to use of ONC-Certified health information technology, use of EHRs not certified by ONC, use of EHRs in clinical investigations, data modifications, audit trails, informed consent, privacy and security of data, and inspection, record-keeping, and record retention requirements.
In summary, FDA has provided much needed guidance on the use of EHR in prospective clinical investigations for human drugs, biological products, medical device and combo products for sponsors, clinical investigators and CRO’s. We see great opportunities at the convergence of EHR and EDC systems and the expanded use of rich EHR data in clinical trials to accomplish goals that are otherwise not possible.
For complete details, please read the guidance.
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