FDA Issues Report on Devices

FDA https://www.fda.gov released the report “Report on Non-Device Software Functions: Impact to Health and Best Practices-December 2018” describing the benefits and risks of digital health tools that are not regulated by the FDA as medical devices.

FDA Commissioner Scott Gottlieb MD explained, “While we’ve been working to streamline the agency’s oversight of digital health products, we also know that there are many digital products consumers are using for their general wellness or to track their health information that aren’t regulated as devices by the FDA. Also, the healthcare system is also increasingly relying on digital tools like EHRs to advance patient care.

The report discusses how these products fit into the digital health landscape and how they may or may not impact patient health. FDA’s report analyzes the potential benefits and risks of software products that fall in this category, such as e-prescribing software or mindfulness apps.

Although FDA believes that the benefits of these products generally outweigh the risks to patients, FDA still encourages consumers and healthcare providers to stay informed on the benefits and risk of any of the digital health products.

Section C under Summary Findings specifically describes how Electronic Patient Records impact patient safety. A retrospective study observed an overall decline of 27 percent in reported patient safety events associated with the use of EMRs.

Another retrospective study analyzed patient safety reports for potential risks associated with EHRs in the Pennsylvania Patient Safety Authority database. Of the 1,735 million reported events evaluated, 0.03 percent stated that EHR usability issues contributed to patient harm. However, the authors of the study noted that a causal effect could not be identified due to limited information in the patient safety reports.

An adverse event related to EHRs was reported to FDA. The report stated that an EHR included erroneous information which led to incorrect care and resulted in the patient’s death. However, a causal relationship between the EHR issue and the limited information provided in the adverse event report could not be determined.

Another study evaluated patients’ electronic sharing of personal health records with their providers. Results indicated that providers reported confidence in the accuracy of the information and improved their ability to have an accurate medication list which helped them make medication treatment decisions.

Outside experts suggest that patient education information and care plan details should be included in the patient’s EHR portal since medical terminology is not always understandable to everyone. It was also suggested that in order to mitigate issues with terminology, targeted education could be used to improve patient comprehension of EHR notes.

As to the software design, experts suggest that when developing this type of software, developers may not have the clinical understanding to address all safety elements of the software design as well as any changes to the design. Experts suggest that all stakeholders that touch EHRs be engaged in the development, verification, and validation activities.

It is suggested that to maximize a patient’s understanding of their health data, pictures and graphs should be used to explain data using lay terminology whenever possible, while building targeted education into EHR notes.

Go to https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM628128.pdf to view the report.

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