Carolyn Lye

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Carolyn Lye is an associate practicing in the firm’s health care group. She provides transactional, regulatory, and compliance advice to a broad range of health care clients, including health care providers, academic medical centers, research institutions, pharmaceutical and medical device manufacturers, health care technology companies, and investors. Since joining the firm, Carolyn has also co-authored several articles focused on regulatory matters within the health care industry, such as interoperability, information blocking, research integrity and security, digital health, and drug pricing.

Carolyn attended Yale Law School as part of the J.D./M.D. dual degree program, graduating concurrently from Yale School of Medicine in 2022. During law school, Carolyn was also the editor-in-chief of the Yale Journal of Health Policy, Law, and Ethics. As a student fellow at the Solomon Center for Health Law and Policy, Carolyn helped to create the first publicly accessible and regularly updated database tracking legislation on palliative care. As a member of the Reproductive Rights and Justice Project, Carolyn helped to establish Connecticut’s first abortion fund.

Experience

Provides pharmaceutical companies with in-depth review and strategic advice regarding drug pricing and compliance with government price reporting requirements under Medicare Part B, the Medicaid Drug Rebate Program, 340B Drug Pricing Program, and the Veterans Health Care Act, including around drug and biological product launches, line extension considerations, and introductory pricing and packaging.
Assists pharmaceutical companies with developing and implementing market access strategies, including with respect to negotiation and implementation of a range of pharmaceutical supply chain commercial agreements.
Advises pharmaceutical companies on business and legal considerations relating to free drug programs and other patient support programs.
Counsels academic medical centers, institutions of higher education, and health care systems on academic affiliations, research collaborations, and accreditation matters, including research collaborations involving the provision of services relating to human subjects and animal research operations and Institutional Review Board and Institutional Animal Care and Use Committee oversight.
Counsels academic medical centers and institutions of higher education regarding allegations of research misconduct, other issues relating to research integrity and reliability of scientific data, and research security governance and implementation of federal research security mandates, such as National Security Presidential Memorandum 33 (NSPM-33).
Counsels private equity firms and pharmaceutical companies on regulatory considerations for health care transactions.
Advises health care technology companies regarding interoperability, information blocking, and ONC Health IT Certification Program requirements.
Provides regulatory support to research institutions regarding institutional requirements of animal research oversight bodies, including the Office of Laboratory Animal Welfare, the U.S. Department of Agriculture, and the Association for Assessment and Accreditation of Laboratory Animal Care International.
Counsels research institutions on institutional requirements relating to biosafety, select agents and toxins, and dual use research of concern.
Provided pro bono advice to a nonprofit public health services organization regarding federal grants and contracting issues.

Credentials

Publications

Co-author, “HHS Announces New and Renewed Efforts to Promote Health Information Sharing and Interoperability,” Westlaw Today (September 24, 2025)
Co-author, “Maintaining the Integrity of the Biomedical Research Record Through Timely, Appropriate Corrective Action,” Journal of Law, Medicine & Ethics (August 28, 2025)
Co-author, “Disparate Data Retention Standards in Biomedical Research,” Accountability in Research: Ethics, Integrity and Policy (August 6, 2025)
Co-author, “Biden Administration Finalizes its Last Changes to Health Data Interoperability and Information Blocking Regulations,” Westlaw Today (January 30, 2025)
Co-author, “What to Expect Next From Federal Health Tech Regulation,” Law360 (November 13, 2024)
Co-author, “CMS Issues the Long-Awaited Medicaid Drug Rebate Program Final Rule, with Fewer Changes than Anticipated,” Ropes & Gray Alert (September 23, 2024)
Quoted, “‘The PubPeer Conundrum:’ One View of How Universities Can Grapple with a ‘Waterfall of Data Integrity Concerns’,” Retraction Watch (September 4, 2024)
Co-author, “The PubPeer Conundrum: Administrative Challenges in Research Misconduct Proceedings,” Accountability in Research (August 14, 2024)
Co-author, “15 Areas That Would Change Under Health Data Rule Proposal,” Law360 (August 6, 2024)
Co-author, “Final Issuance of Federal Guidelines for Security in Scientific Research: Impact on Universities, Academic Medical Centers and Other Research Institutions,” Ropes & Gray Alert (July 23, 2024)
Co-author, “NIH Develops Key Considerations for Informed Consent for Research Using Digital Health Technologies,” American Health Law Association Health Law Weekly (June 14, 2024)
Co-author, “CMS Finalizes New Electronic Prior Authorization Requirements for Payers and Providers,” Westlaw Today (February 7, 2024)
Co-author, “HHS-ONC Finalizes Rule with New Requirements for Use of AI in Certified Health IT and Information Blocking Modifications,” Westlaw Today (January 18, 2024)
Co-author, “Meaningful Disincentives: New Proposed Rule to Deter Health Information Blocking,” Westlaw Today (November 21, 2023)
Co-author, “Raising the Floor: CMS Proposes New Nurse Staffing Requirements for Long-Term Care Facilities,” Ropes & Gray Alert (September 26, 2023)
Co-author, “Compliance Takeaways From HHS Information Blocking Rule,” Law360 (July 28, 2023)
Co-author, “A New Wave of Agency Action Around Drug Pricing: CMS Proposes Sweeping Medicaid Drug Rebate Program Rule,” Ropes & Gray Alert (May 31, 2023)
Co-author, “ONC proposes significant changes to health IT certification program and information blocking rule,” Westlaw Today (May 3, 2023)
Co-author, “Extrapolation Has Arrived: CMS Finalizes Medicare Advantage Risk Adjustment Rule,” Ropes & Gray Alert (February 16, 2023)
Co-author, “Patient Electronic Access to Final Radiology Reports: What Is the Current Standard of Practice, and Is an Embargo Period Appropriate?,” 300 Radiology 204382 (2021)
Co-author, “Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies,” 180 JAMA Intern. Med. 1145 (2020)
Co-author, “Understanding the Role of Law in Reducing Firearm Injury through Clinical Interventions,” J. Law Med. Ethics (2020)
Carolyn T. Lye et al., “Evaluation of the Patient Request Process for Radiology Imaging in U.S. Hospitals,” 292 Radiology 190473 (2019)
Carolyn T. Lye et al., “Assessment of US Hospital Compliance With Regulations for Patients’ Requests for Medical Records,” 1 JAMA Network Open e183014 (2018)
Carolyn T. Lye et al., “The 21st Century Cures Act and Electronic Health Records One Year Later: Will Patients See the Benefits?,” 25 J. Am. Med. Info. Ass’n 1218 (2018)

Experience

Credentials

Education

Admissions

Publications

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Areas of Practice