Caroline R. Herion

Artificial Intelligence in Health and Life Sciences

Caroline is a member of Faegre Drinker’s artificial intelligence and algorithmic decision-making (AI-X) team, which advises clients on the regulations and risks that come with AI technologies. With a focus on AI in health and life sciences, she regularly supports health care providers deploying AI tools in clinical settings and life sciences companies incorporating AI into drug development and medical device design. She also helps organizations prepare for growing regulatory scrutiny of algorithmic decision-making.

Caroline leverages deep experience to guide clients in building AI governance frameworks and to navigate the complex regulatory, compliance, and contracting issues raised by AI-enabled products and services. She also advises on FDA regulation of AI-enabled medical devices and software.

FDA Regulatory

Caroline represents medical device, pharmaceutical, and digital health companies on FDA regulatory matters, from premarket strategy through agency engagement. In transactions, she evaluates FDA approval pathways and regulatory risk — including PMA and 510(k) strategies — for medical device acquisitions. Caroline routinely advises on matters that raise both health care regulatory and FDA issues, including those involving digital health, connected devices, and AI-enabled medical technologies. She also counsels on clinical research, including how clinical data is collected and used.

Privacy and HIPAA

Caroline assists digital health, telehealth, and life sciences clients on HIPAA compliance, business associate arrangements, and how HIPAA interacts with comprehensive state consumer privacy laws. She also helps clients stay up to date on emerging US state privacy and artificial intelligence laws, monitoring new legislation to advise on the compliance obligations it creates. She works with health care providers and technology companies on privacy obligations outside of HIPAA, including how to manage privacy risk in new products and services. As part of managing risk, Caroline also strives to help clients develop privacy strategies, policies, consent materials, and data-sharing arrangements for telehealth platforms. She has also led a full assessment and overhaul of a global pharmaceutical company’s privacy program, including data protection officer registrations in more than 30 European jurisdictions.

Health Care Regulatory and Transactions

Caroline’s health care practice combines regulatory and transactional work to advise health systems, pharmacy businesses, and medical technology companies on complex transactions. She leads health care regulatory workstreams in mergers and acquisitions, and strategic transactions from diligence through post-closing while coordinating across multiple regulatory frameworks and stakeholders on compressed deal timelines. That work includes drafting deal documents such as letters of intent and definitive agreements as well as multistate pharmacy licensing, change-of-ownership, DEA, and board of pharmacy matters. She also conducts integrated regulatory, privacy, FDA, and cybersecurity diligence for medical technology acquisitions. Outside the deal context, she advises clients on federal and state health care laws, including federal fraud and abuse laws and the Physician Self-Referral Law (Stark).

Prior Experience

During law school at Emory University, Caroline was a summer legal intern at the US Department of Health and Human Services, Office of the General Counsel, where she worked on Medicare overpayment and fraud matters. Before law school, she was an administrative fellow to the CEO of Emory Healthcare Network, where she advised on Medicare reimbursement changes under the Medicare Access and CHIP Reauthorization Act. She also held positions at Seattle Children's Hospital and in health care technology consulting.