HIPAA and Beyond: Health Information Privacy Updates

Ms. Klein is a leading practitioner on privacy and data protection matters, with a special emphasis on the health and life sciences sectors. She has been recognized by The Legal 500 US in the cyber law (including privacy and data protection) category from 2019 through 2022. She has focused on privacy and data protection law for more than 20 years. Ms. Klein assists clients with issues arising under state and federal privacy, security and data breach notification laws and regulations. These include the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), Section 5 of the Federal Trade Commission (FTC) Act, the FTC Health Breach Notification Rule (HBNR) and myriad state privacy, security and breach notification laws, including the California Consumer Privacy Act (CCPA) and California Confidentiality of Medical Information Act (CMIA). Ms. Klein has examined privacy and data protection issues arising in a broad array of settings, ranging from hospitals to professional sports, including medical device and pharmaceutical companies, developers of health-related apps, and leading-edge technology companies.

Ms. Johnson focuses her practice on matters primarily for clients in the healthcare industry. She provides regulatory and compliance assistance on both a federal and state level. She has assisted clinical laboratories, hospitals, long-term acute care hospitals, community hospitals, physician specialty groups, telehealth providers, surgery centers, healthcare associations, pharmacies, and other healthcare providers on regulatory, licensing, compliance, reimbursement, contractual, and corporate matters. Ms. Johnson has provided support to entities during licensure and accreditation surveys and assisted in navigating state professional licensure laws, CLIA standards and state and federal laboratory laws and regulations, government and private payor reimbursement, state and federal fraud and abuse rules, state telehealth laws, and state and federal pharmacy regulation. She also has advised clients on direct to consumer testing issues and applicable state requirements. In addition, Ms. Johnson has significant experience with HIPAA compliance, including drafting HIPAA policies and procedures, breach response and notification, drafting responses to investigations conducted by the Office for Civil Rights, and advising clients on proactive HIPAA compliance and breach prevention.

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.