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Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals

On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals.  Here are some key takeaways from that webinar:

  • Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company or a digital health company.  For pharmaceuticals, you have to understand that there’s more risk tolerance in the technology space.  For digital health companies, you have to understand healthcare regulation and appreciate all the regulations pharmaceutical companies are dealing with on a regular basis.”

  • Grant Castle from Covington’s London office described how “it’s tempting to think once you’ve understood the regulations, you can enter the market with a digital health product, but in many respects, that’s the start of the challenge.  Systems for pricing and reimbursement of digital health offerings have yet to evolve fully.  It can also be challenging for a pharmaceutical company to offer digital health products where regulations might prohibit pharmaceutical companies from providing incentives to healthcare professionals for its products.  Such issues mean that you need to think strategically.” Sarah Cowlishawadded that digital technologies are being used in drug development, particularly to help collect real world evidence.  Companies thinking about digital health in drug development need to consider other challenges such as data reliability, consent, and operability with other platforms.

  • Christina Kuhn described how different centers within FDA might decide whether a digital health solution is regulated as a device and whether a digital health solution would affect a pharma company’s responsibilities for a drug. Wade Ackerman noted that “companies approaching FDA should think carefully about how to present FDA with the information it needs to understand and assess the digital health innovation.  How companies approach the agency will depend on the particular digital health technology, including how it relates to a pharmaceutical product.”

© 2018 Covington & Burling LLP

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About this Author

grant castle, covington burling, sciences law, medical device attorne
Partner

Grant Castle is a partner in Covington & Burling's London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.

His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.  He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products.  He has developed...

44-20-7067-2006
Sarah Cowlishaw life sciences regulatory solicitor, Covington Burling, law firm
Associate

Sarah Cowlishaw is an associate in the London Life Sciences group who joined the firm as a trainee solicitor in 2009. 

Ms. Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. On the commercial side, she advises on the full range of agreements that span the product life-cycle in the life sciences sector. Her expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements and regulatory services agreements. She also regularly advises on regulatory aspects of corporate/commercial transactions, particularly regulatory due diligence. 

+44 20 7067 2043
Ackerman, Covington
Partner

Through more than a decade of experience in private practice and positions within the FDA and on the Hill, Wade Ackerman has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. Mr. Ackerman advises clients on FDA regulatory matters across a range of sectors, including drugs and biologics, cosmetics, medical devices and diagnostics, and digital health products and services associated with drugs and traditional devices. He serves as one of the leaders of Covington’s multidisciplinary ...

424-332-4763
Christina G. Kuhn, Food & Drug, Litigation Attorney, Covington Law Firm
Associate

Christina Kuhn is an associate in the firm’s Washington, DC office, where she is a member of the Food and Drug and Litigation practice groups.  She provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.

202-662-5653