Medtech companies leveraging data must meet FDA and compliance-related requirements, especially given evolving laws and social concerns.
Here are the top 5 compliance issues for medtech-enabled data platforms:
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Kristin Havranek, Martin Gomez, Matt Wetzel, Steven Tjoe and Stephanie Philbin Kristin Havranek has worked extensively with and in the MedTech industry for the last 25 years. A trusted advisor to investors and companies alike, Ms. Havranek regularly helps startup and emerging MedTech companies build their IP portfolios in a strategic, thoughtful manner with their […]
Medtech companies should be particularly mindful of the following legal and regulatory compliance issues:
1. Data Collection, Use and Sharing
Medtech-enabled data platform companies need to be mindful to take appropriate care of data, including:
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- Patient data
- Drug development data
- Customer/provider data
- AI/ML-developed data sets
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A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Companies should prioritize the following for any data collection, use and sharing:
2. Adapting to Evolving Interactions with Physicians, Patients and Other Stakeholders
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- As the landscape moves from a treatment/provider-centric approach to a preventive/patient-centric one, interactions with patients present a host of additional compliance issues.
- Company relationships with healthcare providers and customers are changing, especially as technology allows for greater real-time monitoring of patients and real-time data entry.
- Enhanced data collection means increased collaboration with stakeholders.
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3. New Regulatory Regimes Around Donation of EHR, Cybersecurity Technology and Information Blocking
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- As HHS implements new regulatory requirements around topics like the donation of EHR & cybersecurity technology, companies needs to be mindful of tracking these donations and transparency requirements, ensuring that each arrangement is supported by legitimate need and addressing topics like updates and replacements.
- New rules on information blocking and defined standards of “interoperability” could have an impact on medtech-enabled data platforms.
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4. Addressing value-based care considerations and the federal anti-kickback statute safe harbors
Medtech-enabled data platform opportunities include: (i) streamlining and coordinating care, (ii) real-time quality and outcomes measurement, (iii) more narrowly tailored, patient-centric solutions, (iv) enhanced data view when coupled with machine learning, and (v) cost savings. However, companies should carefully examine federal Anti-Kickback Statute safe harbors and align their practices to these regulatory requirements.
5. Navigating through the lack of advanced industry standards
Medtech-enabled data platforms reflect a new evolution in the medtech industry, and there is a need for more advanced industry compliance standards beyond the typical topics addressed by industry codes of ethics, like the AdvaMed Code of Ethics. While codes currently focus on traditional sales and commercial arrangements, a growing industry requires new industry-wide thinking on topics like the ethics of data and AI, data sharing among companies and with customers and information blocking.
Kristin Havranek has worked extensively with and in the MedTech industry for the last 25 years. A trusted advisor to investors and companies alike, Ms. Havranek regularly helps startup and emerging MedTech companies build their IP portfolios in a strategic, thoughtful manner with their business goals and needs in mind. She evaluates freedom-to-operate, patentability, investor due diligence and financing IP, and conducts patent validity analyses. She advises on strategic alliances and prepares and prosecutes patent applications before the U.S. Patent and Trademark Office. Ms. Havranek’s ties in the industry run deep and is currently on the leadership team of MedtechWomen.
Martin Gomez is a partner in Goodwin’s Technology Companies group specializing in intellectual property matters. Mr. Gomez focuses his practice on advising technology and life sciences companies of all sizes (including startups), and their investors, in corporate and especially intellectual property matters throughout the business life cycle, including new company formation, IP protection, fundraising, strategic transactions and exits.
Matt Wetzel is an experienced health lawyer and provides strategic advice to life sciences companies on complex health care laws and regulations, including federal and state fraud and abuse laws, Medicare and third party billing and reimbursement regulations, patient privacy obligations, and transparency requirements, among other areas. Matt also works with clients to establish and operate effective global compliance and risk management programs.
Steven Tjoe is a partner in the firm’s Technology and Life Sciences groups and a member of the firm’s FDA practice. He focuses his practice on product development strategies and regulatory compliance counseling, in particular as related to medical devices, digital health products, in vitro diagnostics, laboratory developed tests, compounded drugs, cell and gene therapies, and other drugs and biologics. Steven advises clients in analyzing premarket pathways, product adverse event risk profiles, product communications and marketing, and GMP compliance. Steven also advises on Hatch-Waxman patent listing and exclusivity issues, is a contributor to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S, and regularly conducts risk analyses for offerings and transactions involving FDA-regulated entities across the medical device, drug, and biologic industries.
Stephanie Philbin, a partner in the firm’s FDA practice and a member of its Life Sciences group, concentrates on Food and Drug Administration laws. She joined Goodwin in 2007.
