The Federal Drug Administration is in the process of expediting the approval process for digital health devices. Two important milestones were the release of the Digital Health Action Plan and the “Software Precertification (PreCert) Pilot Program,” which is a key element of the overall initiative.
The goal is to transition approaches traditionally used for hardware-based medical devices into a software landscape that features “faster and iterative design, development, and validation.” The key, however, is to do so without taking shortcuts on quality assurance. “Streamlining processes that have built-in quality assurance processes can provide a great accelerant…to the acceptance of new technologies,” according to Antwanye Ford, the president and CEO of IT management and consulting firm Enlightened. “It is the QA portion of this process that will lead to greater acceptance of new technologies.”
The question of FDA approval raises the issue of how digital health tools are used and managed in the workplace. To some extent, the same common sense rules apply. The workplace, however, has additional concerns related to worker safety – and liability that can stem from that –effectiveness, security and cost/value issues that would be irrelevant for consumers.
Managing apps and online tools in the workplace is a big challenge, but one with a big upside: A healthier and happier workforce.
The FDA Takes Over
U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb announced earlier this year that the agency is moving on an expedited review of digital health devices. Gottlieb pointed to estimates that 165,000 health-related apps would be downloaded 1.7 billion times by iOS or Android users by this year.
That’s a lot of downloads. Gottlieb took great care to point out why such devices are good. It is the FDA’s responsibility to ensure that they are safe and effective as well. The interim goal announced was a pilot program to assess how best the FDA can fill this role.
A Big Step for Vendors, Too
The FDA move to make the process more efficient is important for vendors as well. 9to5Mac referred to an interview with Apple CEO Tim Cook in 2015. The problem was the nature of the stodgy FDA approval process. Cook said that he wouldn’t put the Apple Watch through the existing process because it slows down release.
The idea is that apps can be developed very quickly. They likely would be delayed if they wanted approval for an onboard health care device. This would keep the app off the device, no matter how potentially lucrative the health care is. Cook’s alternative is to put the app through the FDA process, but on an alternative device. The implication is that once approved, their use on the Apple Watch, which would be on the market, would be smooth.
Security. Of course.
The idea of expediting apps makes sense. One thing that must not be compromised, however, is the level of security that these apps and digital tools maintain. The key is to ensure security from day one. Indeed, this need is even greater in the workplace. Organizations have enough security concerns without worrying about cracked corporate wellness and health programs.
“Innovation is part of what makes America great,” said Antwanye Ford, the president and CEO of IT management and consulting firm Enlightened. “Innovation should be encouraged and stimulated by programs such as this. However, technical innovation without a cybersecurity quality assurance makes us a weaker, naïve, and more vulnerable country. We must never fast-track cybersecurity quality assurance.”
More New Tools from the FDA
In addition to the Medical Innovation Action Plan, the FDA also announced the Pre-Cert for Software Pilot Program and the Digital Health Innovation Plan. The goal is to tell consumers and the digital health industry how “we will establish clear and consistent expectations for the products the FDA regulates.”
The FDA plan is to understand the unique properties of digital health products and the marketplace in which they exist. In other words, the FDA says that it recognizes the way in which products were regulated in the past no longer is effective and that a more fluid and agile process is necessary. That is, of course, easy to say. It will be interesting to see how successful the FDA turns out to be.
The FDA Program Raises Questions
A big question is whether the new FDA rules have teeth. Dr. Glenn Cohen, posting at The Health Affairs Blog, writes that the plan “raises as many questions as it answers.”
The FDA plan, he writes, does not include the ability to implement a regulatory framework for software, something that had been in an earlier House version. He also writes that it is possible that the plan will do nothing to help people assess the marketing claims of digital health products. There are also questions about the efficacy of any certification tied to the FDA program.
Businesses Can Take Ownership
The government in general and the FDA in particular spend a tremendous amount of time testing drugs and procedures for safety and effectiveness. There is no reason that the same rigor shouldn’t be applied to apps. That is what the FDA is attempting to do.
Companies can do so as well. At iMedApps, Dr. Brian Chau describes a study of workers in South Korea that was highlighted in the Archives of Physical Medicine & Rehabilitation. The study looked at whether “a mobile app could provide an effective, non-pharmacologic option for neck pain management.”
The article describes the process that was used by the researchers. At the end of the post, Chau offers his own takeaways. The effectiveness of this program is important. At a higher level is the realization that there is a lot organizations can do to ensure health care app safety and effectiveness.
Many Areas Covered by FDA — But Not All
A very good summary of where the FDA seems to be going with its rules was posted by Diane Romza-Kutz at website of the Chicago law firm of Thompson Coburn LLP. She writes that the plan likely will cover wireless devices, mobile applications, telemedicine, interoperability and “when software is a medical device.”
The plan likely will identify low-risk technologies that will not need to be approved. These, she writes, are outside of the agency’s regulatory authority or are thought to simply not merit review or pre-market approval.
Respecting Limits
Handling of personal information is a huge issue with any app. When the app is used in the workplace, a whole host of additional security and personal information issues almost certainly present themselves.
The questions are serious: If an employee is thought to be depressed, should supervisors be alerted and he or she be watched more carefully? How should the organization handle an employee if the app shows that he or she potentially carries a contagious disease? Should permission to share data with authorities be a condition of employment? If a company gathers data indicating that a patient is on the precipice of a health crisis and he or she indeed does have a heart attack, stroke or other crisis, could the company be sued because it didn’t say anything?
Call in the Experts
A good way to manage health care apps in the workplace is to go with an organization with a deep ecosystem. It’s one thing to download something from an online marketplace. It’s another to find tools that are structured, tested, secure, and in other ways proven out in the real world to be safe and effective.
Earlier this year in Singapore, CXA Group, Philips and unidentified Fortune 500 companies piloted an integrated workplace health solution. The digital platform is supported by Singapore-based EDBI. The end-to-end platform is aimed at managing chronic illnesses while controlling the rise in health care costs.
Choose Carefully
It is possible for an organization to spread itself too thin. Offering too many programs, according to realbusiness.com, may devalue these programs and be too much to handle. The site says wellness packages – that include but are not limited to online health apps – should be targeted carefully.
For instance, the means of disseminating information about them should fit the audience. Older workers, for instance, may be more apt to respond to an actual pamphlet describing the program than to an electronic message. The keys are that one size does not fit all and each initiative must be well thought out.
Carl Weinschenk covers telecom for IT Business Edge. He writes about wireless technology, disaster recovery/business continuity, cellular services, the Internet of Things, machine-to-machine communications and other emerging technologies and platforms. He also covers net neutrality and related regulatory issues. Weinschenk has written about the phone companies, cable operators and related companies for decades and is senior editor of Broadband Technology Report. He can be reached at cweinsch@optonline.net and via twitter at @DailyMusicBrk.
