Jamie L. Flaherty
Jamie Flaherty joined Ropes & Gray in 2015 as an associate in the firm’s health care and intellectual property practice groups. Jamie works primarily on health care matters, and advises hospitals, universities, clinical laboratories, pharmaceutical manufacturers, managed care plans, research institutes, and other health care organizations regarding a broad range of regulatory, compliance, financing, and transactional issues. She has represented both academic and industry clients in the area of clinical research.
During law school, Jamie was a member of Boston University School of Law’s Health Law Association. She also served as a note editor for the American Journal of Law and Medicine. Jamie also worked as a judicial intern with the Honorable Juan R. Torruella at the First Circuit Court of Appeals.
- Investigations. Advising research institution in connection with internal investigation involving allegations of research misconduct. Advising health care clients on conflict of interest disclosure practices and policies.
- Regulatory. Advising health care clients on export controls regulations, federal and state anti-kickback statutes, and self-referral laws. Advising clinical trial sponsors and research sites on research policy and compliance issues, including human subjects protection and informed consent. Advising clinical laboratories on state laws pertaining to the return of laboratory results and billing practices. Conducting compliance program reviews for managed care plans with the objective of enhancing the effectiveness of health care compliance program activities to meet continually evolving legal standards and industry best practices. Advising universities and health care clients in responding to FOIA requests.
- Enforcement. Representing health care company in federal False Claims Act qui tam action involving alleged breaches of Medicaid regulatory requirements, Affordable Care Act marketplace regulatory requirements, and billing standards. Representing a medical device manufacturer in investigation involving the Department of Justice. Advising health care client on responses to third-party subpoenas.
- Transactions. Advising several health care and university organizations on corporate finance matters, including tax-exempt public offerings and bank direct purchases. Advising life sciences clients in connection with collaboration and license agreements.
- Pro Bono Matters. Representing pro bono asylum applicant. Assistance with forming non-profit corporations.
- Co-author, “The Evolving Regulatory Landscape for Clinical Trials in India,” Food and Drug Law Institute’s Food and Drug Law Journal (December 2018)
- Co-author, “India Releases New Draft Rules Reinforcing Compensation Requirements for Injuries ‘Related To’ Clinical Trials,” Bloomberg BNA’s Life Sciences Law & Industry Report (April 2, 2018)
- Co-author, “SACHRP Releases Guidance on Broad Consent Under Revised Common Rule,” Bloomberg BNA’s Life Sciences Law & Industry Report (September 15, 2017)
- Author, “Digital Diagnosis: Privacy and the Regulation of Mobile Phone Health Applications,” 40 Am. J. Law Med. 416 (2014)