Managing Pharmacovigilance in Digital Health Initiatives

RAPS.org

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article for the Regulatory Affairs Professionals Society, titled “Managing Pharmacovigilance in Digital Health Initiatives.” The article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives.

Following is an excerpt:

The pharmaceutical industry, most would agree, has been slow to embrace the use of digital technologies, such as the cloud and mobile devices, in delivering healthcare. As with social media, pharmaceutical company involvement in digital health presents many difficult questions, making executives uneasy. Among those questions is which adverse event reporting obligations companies would assume by pursuing digital health strategies. This article analyzes those reporting obligations and, more importantly, identifies ways to reduce regulatory risk and cost associated with digital health initiatives.

More specifically, this article focuses on issues of legal responsibility. Some interesting debates are going on at pharmaceutical companies: lawyers who want to minimize legal responsibilities are arguing with physicians and other scientists who want to aggressively mine any or all data to learn how to improve patient care. At the heart of the debate are ethical and business issues beyond the scope of this article.

See below to download the full article in PDF format or visit RAPS.org (membership required).

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