FDA’s Digital Health Innovation Action Plan Targets Software – Not Hardware – For Regulatory Approval

A few weeks ago I posted an article that spoke to the value connected medicine dispensing could bring to healthcare.

What I neglected to mention is the plethora of HIPAA hurdles that the healthcare industry faces when it begins collecting patient-specific healthcare data on mobile devices such as phones, tablets or wearables.

Thankfully there may be a solution on the horizon that significantly circumvents this challenge.

In the past, if a client were to build an app that collected patient-specific medical data, the entire phone would then be considered a “medical device.” The challenge with this lies in the relative inability of a healthcare company to effectively to manage HIPAA compliance on a device they rarely have contact with.

However, the FDA’s new Digital Health Innovation Action Plan is looking at ways to view the software as the components of a tech solution that needs to be regulated. This effectively paves the way for healthcare companies and the companies to more deeply integrate mobile technology with healthcare.

As part of the plan, the FDA is seeking 9 that meet the following criteria for its pilot initiative;

  • Business is developing or planning to develop tools that meet the FDA’s definition of a device — one intended to be used to diagnose, cure, mitigate, treat, or prevent a disease;
  • Company has an existing track record in developing, testing, and maintaining software products use key performance indicators for quality control;
  • Must agree to provide access to performance measures during the pilot
  • Collect real-world post-market performance data and provide it to the FDA;
  • Availability for consultations and site visits from FDA officials
  • Provide quality management system information

So who did the FDA deem worthy this past week from the pool of over 100 applicants?

  • Apple
  • Fitbit
  • Verily (the health unit of Google parent Alphabet)
  • Samsung
  • Roche
  • Johnson & Johnson
  • Pear Therapeutics
  • Tidepool
  • Phosphorus.

“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices,” FDA Commissioner Scott Gottlieb said in a statement. “These pilot participants will help the agency shape a better and agiler approach toward digital health technology that focuses on the software developer rather than an individual product.”

The end goal of the program is to develop a regulatory framework for software as a medical device so that companies with established, tried and tested quality assurance protocols would be able to update their products faster.

Why It’s Hot:

in the past, mobile devices such as wearables, phone or tablets that collected patient data weren’t HIPAA compliant. This new FDA initiative opens up the potential to build technology that makes these devices HIPAA compliant opening up vast new opportunities for the healthcare industry.