Lucia Savage | Source | Chief Privacy and Regulatory Officer at Omada
Lucia Savage
Lucia has the strategic expertise needed for a 21st Century health care system. She is an experienced C-suite executive and board member, Ms. Savage advises CEO’s, Cabinet Secretaries, and Members of Congress on how health care can most effectively take advantage of ubiquity of digital tools, and how health care is evolving in the 21st Century. Some of the regulations that Lucia has authored have spawned a new health care sector based on APIs and apps for B2C and B2B health information transactions, further powering a digital health economy worth $120 billion in 2018. Her forward-thinking strategies have enabled new multi-million dollar business lines for incumbent data companies such as Optum Labs and Innovalon and start-ups like Amino Health and Komodo Health.
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Omada
Chief Privacy and Regulatory Officer
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FDA's enforcement discretion for digital health is more ambiguous than ever in 2021
Industry regulatory leaders outline the best approaches for digital health companies looking to make sense of FDA's long-in-the-tooth enforcement discretion guidelines.
Article
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I think that's 100% right, [with] the North Star being safety. There's some fundamental philosophical approaches here, and one is don't cut corners that are going to potentially harm patients. Document why you're doing something that you're doing and how it's connected to good science. Those are going to be fundamentals no matter what kind of digital [you're doing].
