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 Cowlishaw added 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.”

Neela Paykel is general counsel at Proteus Digital Health.  Wade Ackerman (Los Angeles), Grant Castle (London), Christina Kuhn (DC), Sarah Cowlishaw (London) are all members of Covington’s global Food, Drug, and Device Regulatory Group and part of Covington’s cross-practice Digital Health team.  If you would like to view a recording of this webinar, please contact Jordyn Pedersen at jpedersen@cov.com.

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Photo of Grant Castle Grant Castle

Grant Castle practices 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.

Grant Castle practices 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 considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Sarah 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. Ms.

Sarah 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. Ms. Cowlishaw also advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Photo of Wade Ackerman Wade Ackerman

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…

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 Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and marketing of digital health technologies.

Photo of Christina Kuhn Christina Kuhn

Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.

Covington Digital Health Team

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with…

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with lawyers who understand how the regulatory, IP, and commercial pieces of the digital health puzzle fit together is essential. Covington offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services. To learn more, click here.