New FDA Digital Health Guidance

The Food and Drug Administration (FDA) has released new guidance related to digital health technologies for remote data acquisition.

We can help your practice get up to date and prepared to minimize breach risks from third-party vendors. Subscribe to stay current and up to date on important matters that will impact your practice.  (To subscribe to our blog ).

The FDA draft report is currently open for public comments and offers recommendations about using digital health hardware to gather information from remote trial participants.

The FDA stated that digital health technology allows for frequent data collection, but stakeholders should ensure their technology is fit for its intended purpose.

Digital health technologies may be used to gather health-related information from study participants and transmit information to authorized parties. This will occur to help evaluate the safety and effectiveness of medical products.

Data that can be collected this way includes ambulation, sleep, performance of tasks, the participants location, and more. It also allows direct collection of information for participants who cannot report their experiences due to age or cognitive impairment.

The tools the FDA is referring to include sensor hardware and software applications.

The FDA’s guidance outlined considerations for study sponsors, including:

  • Technology selection
  • Verification and usability of the technology
  • Data collection tools
  • technology risks
  • Record protection and retention

Public comments are due by March 22, 2022.

We publish vital information on health law topics and news every Wednesday and Friday. To get this important information delivered directly to your mail box, 

Do you need help with updating your Business Associate Agreement or negotiating contracts with third-party vendors?  We can help. Contact Rickard & Associates today!

Related Posts

Categories

Recent Posts

What is the Biggest Threat to Healthcare?
January 30, 2024
How Can I Simplify Estate Planning?
January 11, 2024
I Have a Trust. Now What?
December 7, 2023
Breaking: Corewell Health Breach
December 5, 2023
Should I Add My Child to My Bank Account?
November 30, 2023

Subscribe

Subscribe to Our Newsletter

Subscribe and get your FREE copy of Easy Guide to HIPAA Risk Assessments

An essential tool for all healthcare providers, Easy Guide to HIPAA Risk Assessments breaks down the requirements of HIPAA so you can successfully complete your required risk assessment. (an $8.99 value)

Thank you for subscribing to the Rickard & Associates healthcare blog. You'll receive a confirmation email shortly. After verifying your subscription request, you'll be sent to the "Easy Guide to HIPAA Risk Assessments" download page.