Daniel F. Gottlieb counsels a wide range of healthcare industry clients, including healthcare providers, health plans, health information technology vendors and life sciences companies. He is sought out for his legal knowledge on a number of issues including data protection, health software licensing and other IT transactions, and reimbursement, fraud and abuse, and information blocking matters.
Daniel offers guidance on the intersection of data privacy and security requirements with information blocking prohibitions under the 21st Century Cures Act, the Office of the National Coordinator of Health Information Technology (ONC) final information blocking rule, and Medicare rules. He counsels healthcare clients regarding compliance with numerous federal and state privacy, security and breach notification laws, including the Health Insurance Portability and Accountability Act (HIPAA), the European General Data Protection Regulation (GDPR), California Consumer Privacy Act, the Telephone Consumer Protection Act, and CAN-SPAM. Daniel also regularly advises clients regarding their response to cyberattacks and other security breaches and defends against subsequent investigations by state regulators and the Department of Health and Human Services Office for Civil Rights.
He advises healthcare clients on all aspects of software licenses and other agreements for the acquisition of electronic health record (EHR) systems, enterprise data warehouses and other mission critical health IT and health content. He drafts and negotiates hosting, cloud computing, IT service agreements, as well as license agreements for de-identified health information and other health content.
For healthcare providers and life science companies, he assists with compliance program implementations, compliance audits and government program overpayment and refund matters, including self-disclosures to the Office of the Inspector General (OIG) and Centers for Medicare and Medicaid Services (CMS). Daniel also counsels clients on compliance with Medicare and Medicaid reimbursement, fraud and abuse laws, the PhRMA Code on Interactions with Health Care Professionals and the AdvaMed Code of Ethics on Interactions with Health Care Professionals.
Represented numerous electronic health record vendors and healthcare providers regarding the implementation of the information blocking prohibition under the 21st Century Cures Act and the ONC’s final information blocking rule.
Represented numerous hospital systems and other healthcare providers in the acquisition of electronic health record systems, enterprise data warehouses and related services from leading health IT vendors.
Advised numerous colleges and universities, academic medical centers, health plans, health IT vendors and life sciences companies regarding the applicability of GDPR, legal basis for processing personal data, notices and consents and other GDPR implementation matters.
Advised healthcare providers, health plans and health IT vendors on all aspects of responding to security breaches, including internal investigations, drafting breach notification letters, drafting breach reports to federal and state regulators, developing corrective action plans, as well as defending against federal and state investigations and subsequent consumer class action litigation.
Served as Medicare reimbursement counsel in defense of whistleblower actions under the False Claims Act alleging Medicare billing, Stark Law and Anti-Kickback Statute violations.
Represented hospitals and physician practices undergoing audits of meaningful use attestations under the Medicare EHR Incentive Program.