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FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements.

With the increased use and availability of remote monitoring and wearable devices, device manufacturers are collecting an extensive amount of patient-specific information. Patient-specific data collected from such devices may include, for example, data on pulse oximetry, heart electrical activity, blood pressure, and blood glucose readings, as well as information on device usage, alarms, and other outputs. This information is used by patients’ physicians to help them develop an adequate patient treatment history and treatment profile, and to improve the device use experience. Privacy requirements, however, have triggered concerns about whether device manufacturers may disseminate patient-specific information to the affected patients themselves. In response to these concerns, on June 10, the US Food and Drug Administration (FDA) issued a draft guidance providing recommendations to device manufacturers on sharing of patient-specific data derived from medical devices with patients.[1]

Federal Law on Dissemination of Patient-Specific Information

The enactment of the Health Insurance Portability and Accountability Act (HIPAA) has raised public awareness about patient privacy concerns. However, this increased sensitivity has in some cases led to a misunderstanding of the privacy requirements. Although HIPAA requirements are intended to prevent device manufacturers from sharing a patient’s private health information with covered entities (e.g., health plans, certain healthcare providers), they are not intended to prevent manufacturers from sharing a patient’s data with the affected patient. Indeed, many healthcare experts believe that providing patients with their personal health data will empower them to become more engaged in improving their own health.

The Federal Food, Drug, and Cosmetic Act (FFDCA) generally does not require that manufacturers share patient-specific information with the patient. Device manufacturers, however, are permitted to share patient-specific information from a legally marketed device with a patient—at the patient’s request—without obtaining any additional premarket review, provided that it is consistent with the intended use of the device. In many cases, this information is readily accessible by the patient already, either directly (e.g., via a display on a wearable or remote monitoring device) or through the patient’s healthcare provider.

Content and Context for Patient-Specific Information

In the draft guidance, FDA recommends that, in sharing patient-specific information, device manufacturers should exercise care to ensure that information provided to patients is easy to understand and will not be misinterpreted. Specifically, FDA recommends that manufacturers take the following precautionary steps:

  • Consider the intended audience.

  • Ensure that the patient-specific information is comprehensive and contemporary.

  • Provide relevant context to avoid misinterpretation (e.g., information regarding how a physiological parameter is measured).

  • Advise patients who they can contact for follow-up information.

Comment Period

Comments on the draft guidance should be submitted to Docket No. FDA–2016–D–1264 by the due date of August 9, 2016, in order to be considered before the final guidance is prepared.

[1] FDA, Dissemination of Patient-Specific Information from Devices by Device Manufacturers – Draft Guidance for Industry and Food and Drug Administration Staff (June 10, 2016).

Copyright © 2023 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume VI, Number 167

About this Author

Elizabeth Bierman, Regulatory and compliance lawyer, Morgan Lewis
Senior Counsel

M. Elizabeth Bierman represents US and international companies in US Food and Drug Administration (FDA) and state regulatory matters that impact the development, manufacturing, and marketing of their products. Beth has more 25 years of experience representing companies that produce a range of products regulated by the FDA, including medical devices, digital health products and mobile medical applications, tissue products, combination products, pharmaceuticals, medical foods, and infant formulas. She also provides guidance on related jurisdictional issues and regulatory...

Michele L. Buenafe, Morgan Lewis, Regulatory and Compliance Attorney

Michele L. Buenafe advises clients on regulatory, compliance, and enforcement issues related to the development, manufacturing, marketing, labeling, and advertising of medical devices, human tissue products, pharmaceuticals, controlled substances, listed chemicals, and combination products. She also advises clients on emerging legal issues relating to digital health platforms such as mobile medical apps, clinical decision support software, telemedicine systems, wearable devices, and other health information technology. Michele also serves as a co-leader for the firm’s...