White Paper

3 Pages
  • 3 Pages

Harmonization of Clinical Research Requirements


Conflicting common rule and CLIA requirements come under the microscope.

In recognition of one such inconsistency, the National Institutes of Health (NIH) recently announced that it had asked the National Academies of Sciences (NAS) to convene a committee to review and evaluate the rules that govern clinical laboratories’ ability to return patient-specific results from tests performed in research laboratories.



Jennifer S. Geetter, Esq.

McDermott Will & Emery

Jennifer S. Geetter is a Partner at McDermott Will & Emery. Ms. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws.

Chelsea M. Rutherford

McDermott Will & Emery

Chelsea M. Rutherford is an associate at McDermott Will & Emery. Ms. Rutherford focuses her practice on corporate, transactional and regulatory matters affecting a wide range of clients in the health care and life sciences industries.

Michael W. Ryan

McDermott Will & Emery

Michael W. Ryan advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, drugs, biological products, and clinical laboratory testing services.

Michael advises clients on the regulatory issues that arise throughout the life cycle of FDA-regulated medical devices, drugs, and biological products. He is particularly experienced in the review of promotional/marketing materials for FDA-regulated medical products, as well as the FDA’s evolving requirements for mHealth products, including mobile medical applications and clinical decision support software.

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