Spotlight Interview: Michael Werner, Partner; Sara Klock, Associate, Holland & Knight
Healthcare Policy attorneys Michael Werner and Sara Klock were featured in an interview with Medical Travel & Digital Health News. They spoke about their respective career paths, from Mr. Werner's experience in the biotech industry to Ms. Klock's background in controlled substances and U.S. Food and Drug Administration (FDA) policy. They also discussed digital health regulations, explaining how the FDA regulates digital health products as medical devices, where telehealth fits in the regulatory scheme and what providers need to know about FDA requirements.
Ms. Klock elaborated on some of the enforcement actions the FDA usually takes, noting that the agency tends to focus on compliance instead of assessing fines.
"The FDA can enforce civil or criminal fines, but that's not common," she said. "The most typical route is that the FDA approaches the manufacturer to become compliant with FDA rules."
Mr. Werner commented that despite the numerous regulations and requirements, digital health presents a promising opportunity for companies and manufacturers looking to expand their business.
"While there are lots of rules that manufacturers need to be aware of, the business environment in the United States is going to be supportive of innovation and growth, making this an attractive time to get into this space," he said.