Healthcare and biotech organizations operate in one of the most highly regulated data environments. As these organizations develop innovative technologies, leverage AI, and expand the use of health information, they must balance innovation with evolving privacy requirements.

The Hintze Health & Biotech Group works with biotechnology companies, medical device manufacturers, digital health providers, consumer wellness companies, and health data platforms to address health AI, privacy and cybersecurity requirements while supporting innovation and managing risk.

Our Capabilities

Health Information Privacy & Cybersecurity Compliance

Hintze advises covered entities, business associates, and health technology companies on compliance with HIPAA, HITECH, and related state privacy laws, including the California Consumer Privacy Act (CCPA). The firm helps organizations develop practical compliance strategies that align with business objectives and regulatory obligations.

Health Information Governance

Hintze develops customized privacy and security governance programs, including policies, training, and operational frameworks that help organizations responsibly manage health information, strengthen stakeholder trust, and support long-term compliance.

Information Blocking

Supporting health information technology companies and application developers, Hintze provides guidance on compliance with the information blocking provisions of the 21st Century Cures Act. The firm helps organizations navigate evolving regulatory expectations while supporting data accessibility and interoperability.

Privacy & Security Risk Assessments

Through privacy and security risk assessments, including HIPAA Security Risk Assessments, Hintze identifies potential risks and provides practical recommendations tailored to each organization’s business objectives, operational needs, and risk profile.

Security Incidents & Breach Response

Hintze helps organizations prepare for and respond to security incidents involving health information. The firm advises on strategies to reduce cybersecurity risk, strengthen incident response capabilities, and manage legal and regulatory obligations when breaches occur.

Data Use Partnerships

Drafting and negotiating agreements involving the use and exchange of health information, Hintze supports organizations engaged in scientific research, personalized medicine, patient care, and other collaborative initiatives involving sensitive health data.

Corporate Transactions

Hintze advises on privacy and cybersecurity considerations in mergers, acquisitions, financings, and other corporate transactions involving health information. The firm conducts and responds to due diligence requests and advises on definitive agreements and post-closing considerations.

Human Subjects Research

Organizations conducting biomedical and behavioral research involving human subjects rely on Hintze for guidance under the Federal Common Rule. The firm advises on privacy protections, research consent documentation, and Institutional Review Board (IRB) submissions.

Regulatory Investigations & Enforcement

Representing clients in investigations and inquiries from the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR), the Federal Trade Commission, state Attorneys General, and other regulatory authorities, Hintze helps organizations navigate enforcement matters and compliance obligations arising from consent decrees and settlement agreements.

Strategy & Communications

Working alongside organizations, Hintze helps integrate privacy into products, services, and brand strategy. The firm supports clients in building trust, competitive differentiation strategies, and communicating their commitment to responsible health information practices.

Public Health Response

Hintze advises organizations on privacy and security issues arising from public health events, including regulatory guidance, telehealth, remote care technologies, and workforce privacy considerations.