Digital medicine is expected to play a major role in the future of healthcare, but stakeholders still need to iron out the wrinkles. This is the state of digital medicine regulation today and where it could go from here. 

It's exciting to think of a future where digital medicine powers faster, more accurate, and more effective diagnosis and treatment for all that ails us. Yet innovation isn't all that's required to reach that ultimate goal. Smart, transparent, and highly applicable regulation will ensure these inventions are safe and effective.

A white paper, "The Digital Medicine Crystal Ball: Unlocking the Future of Real-Time, Precise, Effective Healthcare," published recently by EBD Group in collaboration with Hogan Lovells and Evidation Health, separates digital medicine from the broader digital health. Digital medicine is "more narrowly focused on the rigorous clinical validation and health system disruption by products and technologies." That means regulation is a key part of the landscape for digital medicine.

Impatience with FDA is not new, but the emerging area of digital medicine appears to be one where there is more uncertainty than usual around regulatory requirements.

FDA has offered guidance in some corners of the space, such as general wellness and mobile medical apps. Still, industry is clearly looking for more. The Clinical Decision Support Coalition recently submitted a citizen petition asking FDA to address specific questions on the regulation of digital health pharmaceutical products--the group termed this "case study guidance." (Read more on this here.)

Discussing FDA's current approach, Yarmela Pavlovic, partner at Hogan Lovells in San Francisco, told MD+DI, "I think that [FDA] wants to be collaborative, but I also think that they feel like they need to put the time into learning about new technologies and figuring out how best to approach the review."

The novelty of digital medicine technology is part of the reason for regulatory uncertainty. As noted in the white paper, instituting a regulatory framework "has been exceptionally difficult in recent years due to the speed at which technology has advanced, and the differences in diseases and treatments."

Pavlovic explained, "I think there are certain technologies where the requirements are already well understood and the fact that you repackage them in a new way . . . might raise some new kinds of things that need to be evaluated, but for the most part the core elements of that review are going to be very similar." She continued, "But if what you're doing is pretty unique or you are replacing what a physician would have done . . . that raises more complexity that the agency then has to think through."

Innovation in the field keeps moving forward despite the lack of a clear policy. "The problem is, you don't want a knee-jerk response from regulators, but at the same time, the technology continues to evolve . . . What was state of the art six years ago is not state of the art today," Pavlovic said.

What is cutting edge is also being driven forward by partnerships in digital medicine. This dynamic is emphasized in the white paper, which cites a Telstra-sponsored report that found "38% of healthcare firms have more than five digital partners; 59% are also involved in networks, clusters, and/or ecosystems." Other experts have also said they expect to see more partnerships in the space.

There isn't any inherent regulatory risk in building a partnership to advance digital medicine. Pavlovic pointed out that "[Partnerships] mean you can have the 'dream team' for a specific medical problem." Still, all parties do need to consider how and by whom any regulatory considerations will be addressed.

Given the complexity and wide range of digital medicine technologies being developed, what could future FDA regulation look like? Despite the variety of application, there are some similarities between digital medicine offerings that may help streamline future regulation. One such similarity discussed in the white paper is the use of data analytics by many of these technologies.

"There are common elements that digital medicine products present and the goal is for FDA to be consistent about the handling of those common elements across the agency, across product types," Pavlovic said. 

Also, as the digital medicine arena matures, FDA reviewers may grow accustomed to the particular requirements of the category. "I think we'll continue to see the reviewers at FDA get increasingly comfortable with the types of information they see as part of the review of a digital medicine product," Pavlovic noted.

One thing is clear--more input from FDA is a must. 

Pavlovic said, "My hope is that we will see more clarity from FDA, that they'll continue to move forward defining the scope of what they think is important to regulate."

[Image courtesy of JK1991/FREEDIGITALPHOTOS.NET]