FDA Final Guidance on Informed Consent in Clinical Research: Key Revisions, Best Practices for Compliance

Ms. Chmielewski’s practice is solely focused on the representation of healthcare providers, pharmaceutical and medical device companies, and pharmacies in healthcare, healthcare transactions, clinical research, supply chain, and food and drug law. She provides daily counsel to numerous health systems, hospitals, academic medical centers, pharmacies, and biotech, pharmaceutical and medical device companies. Ms. Chmielewski regularly assists clients with the following issues: regulatory compliance governing all aspects of clinical research, investigations of research misconduct, Institutional Review Board issues, the conduct of U.S. and international clinical trials, research grants and funding, government investigations and audits, pharmaceutical product promotion (including counsel on off-label promotion), 510K applications, the regulation of software as a medical device, preparation of research contracts, among other matters.

Ms. Markey focuses her practice on developing practical, operationally focused cybersecurity, privacy and life sciences recommendations for clients. Her patient care background and qualification as a Certified Information Services Security Professional allows her to bring a functional perspective to complex privacy, security and research issues with a focus on solutions that work in the real world. Ms. Markey has significant experience with medical device cybersecurity and cross-border privacy transactions. She assists with risk assessments, incident and breach response, and information governance, as well as IRB issues, clinical trial agreements, conflicts of interest, advice regarding research operations and structure and research misconduct inquiries and investigations.

Ms. Smith advises clients on matters involving Stark Law, False Claims Act, and Anti-Kickback Statute compliance. She has defended clients in government investigations related to Medicare and Medicaid billing and has managed due diligence for major hospital transactions, including M&As. Ms. Smith also assists clients with contesting alleged over-payments, self-disclosing over-payments, and analyzing arrangements under state and federal fraud and abuse authorities. She has experience drafting and reviewing contracts, including clinical trial agreements, clinical product manufacturing agreements, non-disclosure agreements, and consulting agreements. Ms. Smith has advised management on HIPAA compliance, provided guidance on FDA regulatory matters, and managed patent and trademark portfolios. She also has experience with data breaches, including a multistate breach involving sensitive health information.