AMPLEXOR in PharmExec.com
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.