Health +
Biotech
Group
The Hintze Law PLLC Health & Biotech Privacy Group provides sophisticated counsel to clients on the complete range of health information privacy and security issues and regularly develops comprehensive privacy and security compliance programs for biotechnology, medical device, digital health, and consumer wellness companies, as well as data analytics and machine learning platforms that work with health information.
The matters we handle include:
Health Information Privacy and Data Security Compliance. We provide guidance to covered entities and business associates on compliance with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH) and related state laws, such as the California Consumer Privacy Act (CCPA).
Enforcement Defense. We have extensive experience responding to HHS OCR, FTC, and Attorneys General investigations, as well as managing compliance with consent decrees and settlement agreements.
Health Information Governance. We develop customized privacy and security policies, training, and programs for clients, and advise them on maintaining stakeholder and public trust and compliance with health information privacy and security laws.
Information Blocking. We advise health information technology companies and app developers on compliance with the information blocking prohibition under the 21st Century Cures Act.
Privacy and Security Risk Assessments. We conduct privacy and security risk assessments, including HIPAA security risk assessments, and provide strategic recommendations for remediation tailored to each client’s risk tolerance, size and business needs.
Health Information Security Incidents and Breaches. We advise clients on strategies to minimize data security risks and provide counseling on effectively and efficiently responding to security incidents and data breaches involving health information.
Data Use Partnerships. We draft and negotiate partnership agreements to use and exchange health information to advance scientific research, personalized medicine, and patient care.
Health Information Risk and Corporate Transactions. We have deep expertise conducting and responding to privacy and security due diligence inquiries in corporate transactions involving health information, as well as advising on best practice for definitive agreements and post-closing.
Human Subjects Research. We work with organizations developing and managing biomedical and behavioral research involving human subjects under the Federal Common Rule, including advising on IRB submissions, privacy protections and research consent documents.
Strategy and Communications. We work with companies to build privacy into their brands, create competitive differentiation strategies, and develop key messaging around health information privacy and security.
Pandemic Response. We advise clients on privacy and security issues raised by the coronavirus (COVID-19) pandemic, including HHS OCR enforcement discretion, telehealth platforms, telehealth, and return-to-work policies.
Contacts
Sheila Sokolowski
Partner - Co-Chair
Mason Fitch
Senior Associate
Kate Black
Partner - Co-Chair
