Health Data and HIPAA: Where Business Needs Meet the Privacy Rule

Ms. Beacom’s practice bridges FDA and healthcare enabling her to provide comprehensive, effective, and innovative legal solutions. She has developed a broad range of regulatory experience, representing clients in complex regulatory and administrative issues including navigating regulatory and policy matters involving the FDA and FTC; assisting parties in transactions based upon FDA-regulated products, including mitigation of FTC inquiries and other compliance challenges; counseling on advertising and promotional related issues and assisting clients in engaging with the regulatory process through federal submissions; structuring health care arrangements, including equity and asset purchases of pharmacies, home health agencies, hospices, and laboratories; counseling health care entities regarding reports to the National Practitioner Data Bank and state licensing boards; and assisting in responding to government or private contract inquiries, suspensions, or terminations of facility/individual enrollment or licensure.

Ms. Watkins represents various healthcare providers and companies, including, but not limited to, individual providers and provider practices, long-term care and skilled nursing facilities, laboratories, technology companies, and insurers and health plans. Ms. Watkins also assists clients with developing and managing compliant healthcare programs. Her practice involves assisting clients with regulatory compliance, health information privacy advising, Medicare and Medicaid/Medi-Cal reimbursement and overpayment issues, licensure and credentialing disputes, and transaction due diligence and structuring. Ms. Watkins experience includes knowledge of the Health Insurance Portability and Accountability Act (HIPAA), corporate practice of medicine, Stark Law, Anti-Kickback Statute (AKS), Eliminating Kickbacks in Recovery Act (EKRA), contract disputes, administrative law and regulatory enforcement actions, compensation and policy reviews, and the development and implementation of compliance plans for clients.