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

Counsels academic medical centers, institutions of higher education, and health care systems on academic affiliations, research collaborations, research compliance, and accreditation matters.
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).
Advises pharmaceutical manufacturers regarding government price reporting obligations under Medicare Part B, the Medicaid Drug Rebate Program, 340B Drug Pricing Program, and the Veterans Health Care Act.
Advises health care technology companies regarding interoperability, information blocking, and ONC Health IT Certification Program requirements.
Counsels private equity firms and pharmaceutical companies on regulatory considerations for health care transactions.
Provided pro bono advice to a nonprofit public health services organization regarding federal grants and contracting issues.

Credentials

Publications

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

Areas of Practice