Digital Health: Regulatory, Compliance, and Legal Challenges

At this month's AMPLEXOR Life Sciences’ “Be The Expert” conference in Dubrovnik, Croatia, Ilyssa Levins, president and founder of the Center for Communication Compliance, talked about some of the regulatory, compliance and legal challenges posed by the digital health revolution. Pharm Exec caught up with Ilyssa for her views on how pharma companies’ regulatory affairs departments are adapting to this new era.

PharmExec: What are the key regulatory, compliance and legal challenges that the digital health revolution has created?

Ilyssa Levins: There are several – beginning with the fact that regulatory authorities must accept the use of new technologies to capture real-world evidence (RWE), in addition to the use of patient reported outcomes (PROs) as surrogate endpoints, either for clinical efficacy or for quality of life. For example, can a company make an efficacy claim for pain if a digital device confirms that an arthritis patient has moved more during the day?

Then there is the use of unauthorized patient data which could give rise to increased privacy-based litigation, or there could be a failure to adequately capture and report adverse events in timely manner. Digital data collection directly from patients could reduce the learned-intermediary defense in product liability cases, while interoperability and functionality of healthtech can pose technical challenges. 

In your view, how successfully are pharma companies’ regulatory affairs departments adapting to this new era for product development?

Quality data is at the heart of an efficient and robust regulatory strategy for digitally developed products which makes digital innovation a natural fit for RA professionals responsible for regulatory information management. Regulatory departments will need to evaluate the implications of data collected for labeling and claims through healthtech modalities, review the proposed endpoints based on RWE and help make the case for claims based on these new types of data.

For those that may be lagging behind, what do they need to do to ensure successful participation in the digital health revolution?

Even if a life sciences organization is still developing its digital strategy, there is one foundational step for nurturing digital innovation: invest in building high performing, agile cross-functional teams and start knocking down internal silos. The development andd launch of truly patient relevant products requires collaboration which is why the c-suite must prioritize a new metric for success: return on collaboration (ROI). 

Where in the spectrum of healthcare provision do you see digital innovation having the greatest potential to make an impact?

Drug development may reap the greatest benefits at this stage of the digital revolution.  Digital tools enable the development of patient relevant products based on PROs and other non-traditional data. Life Sciences should begin early to integrate digital and behavioral tools into clinical design so resulting and potentially differentiating data are included in the regulatory submission. Of course, optimal pre-commercialization steps are foundational for successful commercialization.

Do you think regulators in the US and Europe are up to speed with the advances being made in digital health? Are they doing enough to facilitate the industry’s optimization of new technologies?

No matter what part of the world, regulatory science and digital development are not always aligned and innovation will always outpace policy. With that said, the U.S. FDA’s Digital Innnovation Action Plan is designed to help encourage digital health innovation by redesigning and bringing clarity to FDA policies and processes. FDA commissioner Scott Gottlieb says he’s focused on fostering innovation at the intersection of medicine and digital health technology. That fact, coupled with the Agency’s patient-focused drug development program (integrating the “patient voice”), fosters a ripe environment for digital innovation. In addition, the 21st Century Cures Act enacted by the U.S. Congress creates a window of opportunity to develop rigorous evidence-based standards that allow reliance on data developed in less traditional forms, most notably patient-experience data.