Blog — Clinical Pathways

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digital health

Digital Health Information: Applicable to HIPAA Breach Notification? Policy Statement Clarifies

02/08/2022

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Recently, many guidance documents and draft guidance documents regarding digital health information have been released. This is in response to the increase in numbers of devices used in the course of a clinical trial, including wearable devices, ePRO, eCOA, software such as apps, home monitors, etc. These devices collect health information and store or transmit it outside of the collection site. Such vendors need to be aware of how they are classified to ensure compliance with applicable regulations. If they are not directly considered a medical device, the device manufacturers and app developers may be considered vendors of personal health records (PHR) and would then need to comply with the Federal Trade Commission’s (FTC) Breach Notification Rule. The FTC released a Policy Statement to clarify the scope of this Rule.

Remote Data Collection in Clinical Trials Draft Guidance

01/25/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” for public comment in December 2021. The draft guidance provides best practices for how digital health technologies (DHT) can be used to collect and support endpoint data and what information is needed in an investigational new drug application (IND) or an investigational device exemption (IDE) application that uses DHT. DHT is a “system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses.”

Device Software Functions Draft Guidance: Comment Now!

01/04/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Content of Premarket Submissions for Device Software Functions.” The draft guidance clarifies documentation that is needed for a premarket submission for device software functions. The 21st Century Cures Act excluded certain software functions from the definition of device (see the guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”). The draft guidance addresses these changes as well as the evolution of digital health and the recent FDA recognized consensus standards for software, which are standards that the FDA determines can support clearance or approval of a device.