Healthcare and the New Trump Administration: Navigating the Evolving Regulatory Landscape; Client Advisory Strategies

Ms. Papish concentrates her practice on matters involving healthcare fraud and abuse and white collar defense. Notably, she has significant experience working on a range of high-stakes, complex civil and commercial litigation matters and government and internal investigations. Ms. Papish regularly represents clients in False Claims Act litigation and related civil and criminal investigations by the U.S. DOJ, HHS-OIG, FDA, DEA, and other federal and state regulators.  Her work is concentrated on the healthcare and life sciences industries but has spanned a number of others, including technology and financial services.

Ms. Klein advises businesses on assessing and mitigating risks related to the privacy and security of personal data, ownership, and commercialization of data AI; planning, drafting, and implementing privacy, security, and data protection policies and “best practices”; compliance with global, federal, and state privacy and security laws, regulations, and rules; data governance; and breach response, crisis management, and remedies for noncompliance. She has deep experience in negotiating and drafting complex technology and cloud transactions, licensing, and strategic IT and commercial agreements. Ms. Klein is a member of an HHS task force that is addressing aligning healthcare industry security approaches to responding to cybersecurity threats under the Cybersecurity Information Sharing Act of 2015. She also is a commissioner of the Electronic Healthcare Network Accreditation Commission, a voluntary, self-governing standards development organization established to develop standard criteria and accredit organizations that electronically exchange health care data. She is the former associate general counsel at Siemens Medical Solutions USA where she notably focused on operationalizing healthcare and life science regulations, including HIPAA/HITECH and the Common Rule in research.

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.