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# More Clarification Sought in Electronic Records Guidance
- URL: https://www.fdaweb.com/more-clarification-sought-in-electronic-records-guidance/
- Published: 2016-07-28T12:00:00.000Z
- Updated: 2026-09-14T21:18:48.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5136337

AdvaMed says that there are significant barriers to implementing the types of systems described in an FDA draft guidance on using electronic health record (EHR) data in clinical investigations, including lack of interoperability of the systems between healthcare systems. “Some systems are not designed to communicate with other systems,” the association says in a comment [letter](https://www.regulations.gov/document?D=FDA-2016-D-1224-0015&ref=fdaweb.com), “and some systems, while designed to communicate, only communicate with a limited number of other systems or are not compatible with other systems in the facility. In addition, there are significant privacy and security concerns, both real and perceived, that prevent the open sharing of data even when it may be in the best interest of the patient or public health, and even when such sharing may be allowable under current laws.”

The letter includes a request for additional clarification on specific technical issues and also includes line-by-line specific comments.

Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://www.regulations.gov/document?D=FDA-2016-D-1224-0026&ref=fdaweb.com) the draft “is a significant first step in building efficiencies in data collection and avoiding transcription errors.” Although it’s not included in this document, PhRMA says FDA should consider providing additional draft guidance on the inclusion of electronic health record data in support of fulfilling postmarketing requirements and the approval of additional indications.

“When new processes are introduced for the conduct of clinical investigations,” the letter says, “it is important for sponsors to receive consistent information from, and have timely and frequent discussions with, the agency. Having early and frequent discussions regarding the use of EHR data will give the agency confidence that EHR data are being used appropriately and effectively in clinical investigations and will give sponsors clarity as to how the agency will be validating the EHR source data.”

The Association of Clinical Research Professionals [says](https://www.regulations.gov/document?D=FDA-2016-D-1224-0011&ref=fdaweb.com) it appreciates FDA development of the guidance because there is a need for clarity on the agency’s expectations when EHRs are used as a source of clinical investigation data.

Also glad to see the guidance was the Association of Clinical Research Organizations, which [says](https://www.regulations.gov/document?D=FDA-2016-D-1224-0006&ref=fdaweb.com) the document “highlights the potential technical issues (which are significant) with exchange of information between the EHR and EDC (electronic data capture) systems. This is, no doubt, compounded by the multiplicity of EHR systems, and security, access and control issues that need to be appropriately managed.” The association also recommends that the final guidance include a sentence or two to clarify if the EHR guidance has any impact on the HHS certification for systems.

Finally, the Biotechnology Innovation Organization [says](https://www.regulations.gov/document?D=FDA-2016-D-1224-0028&ref=fdaweb.com) that in general, the draft is “helpful and well-constructed, providing useful information to assist sponsors in incorporating and integrating EHR data into FDA-regulated clinical investigations.” It asks for additional clarification on sponsor responsibilities and how FDA intends to uphold EHR data standards through on-site inspections and audits. It says the guidance also should acknowledge the responsibilities of the principal investigator and the associated organization or institution, making clear distinctions between the sponsor and the investigator. Clarity is also needed, the letter says, on a sponsor’s responsibility regarding extracted data.