Our colleague Bethany Hills recently discussed the Food and Drug Administration’s Digital Health Innovation Plan, which sets forth the agency’s new approach to regulating digital health. Her discussion appears in a FierceHealthcare article published earlier this week entitled “9 Companies Will Play a Huge Role in Shaping the FDA’s Novel Approach to Digital Health.” The full article can be found here. Stay tuned for additional coverage related to the agency’s evolving digital health strategy.

Join us next Wednesday, February 15 from 1pm – 2pm Eastern for the final installment of our three-part webinar series on the 21st Century Cures Act (the “Cures Act”).  Part III of the series will focus on the Cures Act’s impact on the FDA and will have some great takeaways for anyone who interacts with the FDA or has an interest in the Cures Act.

In this presentation, our colleagues Bethany Hills and Joanne Hawana will discuss the following FDA-related provisions of the Cures Act and take a deep dive into the practical implications and implementation processes for each of:

  • Regenerative Medicine
  • Medical software/digital health
  • FDA restructuring/structural improvements
  • Health care economic info and off-label communications
  • Data source changes – patient experience, RWE and summary data

Click HERE to register!

Written by:  Stephanie D. Willis

The mobile app and wearables market in health care is booming, most recently evidenced by Apple’s entry into the market with its widely-anticipated “HealthKit,” a purportedly secure platform that allows mHealth apps to share user’s health and fitness data with the new Health app and with each other.  But mobile apps, particularly those used by health care organizations, can allow unauthorized access to patients’ Protected Health Information if not evaluated for security and privacy risks.   For guidance on how to address these risks,  click here to see our post at Privacy & Security Matters on the draft Technical Considerations for Vetting 3rd Party Mobile Applications (the Vetting Report) issued by National Institute of Standards and Technology (NIST) in August 2014.

NIST is seeking comments on the Vetting Report until September 18th, so there is still time for organizations contemplating a third party mobile app vetting process to inform NIST of any gaps that remain to be addressed in the Vetting Report.  Regardless, all organizations, especially those in the health care industry, that want to use mobile app technologies in their operations should use the Vetting Report and NIST’s other guidance publications, in conjunction with the advice of experienced health care privacy counsel, to develop their own privacy and security evaluation processes to help weed out the mobile apps that may create risks of security incidents and breaches.

Written by:  Stephanie D. Willis

The HHS Office of the National Coordinator (ONC) released its report “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure” (the “Vision Plan”) last week to help refocus stakeholders on HHS’s goals for the use of health IT in the U.S. health care system.  Although the goals are largely aspirational, the Vision Plan nevertheless articulates the ONC’s expectations of the IT capabilities that patients, providers, and other health care stakeholders should be able to leverage to improve health care quality and lower costs by 2024.

The ONC’s approach to the next decade of health IT advancement follows a three-phase approach, using the three-, six-, and ten-year marks as milestones for achieving broadly-defined goals.  To better understand the ONC’s milestones for health IT infrastructure development and usage, it is helpful to visualize the phases as one would envision building a house from the ground up. Continue Reading The ONC’s Health IT Vision Plan: A Building Under Construction