Healthcare & Life Sciences Technology Counsel

Healthcare & Life Sciences Technology Counsel

The convergence of healthcare and technology has created a regulated industry where compliance failures carry both financial and reputational consequences. Digital health platforms navigate HIPAA, the FDA’s software-as-a-medical-device (SaMD) framework, state telehealth licensing, and a patchwork of consumer health privacy laws (Washington’s My Health My Data Act, California’s CMIA, Connecticut’s data privacy act). John Montague, Esq. advises digital health startups, healthtech platforms, AI-powered diagnostic companies, electronic health record vendors, telehealth providers, and life sciences technology companies on the regulatory and transactional matters that distinguish this sector from generic SaaS or consumer technology work.

For complementary coverage of biotech, pharmaceuticals, medical devices, and traditional life sciences (clinical trials, FDA premarket pathways, IP licensing), see our dedicated Biotech, Life Sciences & MedTech practice page.

HIPAA, Business Associate Agreements, and PHI Compliance

Any technology company that touches protected health information (PHI) on behalf of a covered entity is a HIPAA business associate, subject to the Security Rule, Breach Notification Rule, and a meaningful enforcement risk under HHS-OCR. We negotiate business associate agreements (BAAs) for digital health vendors, draft downstream BAAs with subcontractors, design HIPAA-compliant data architectures, and respond to breach incidents. The compliance posture for a HIPAA business associate is different from generic SaaS — encryption, access controls, audit logging, breach notification timelines, and incident response procedures must all map to the Security Rule’s technical, administrative, and physical safeguards.

FDA Regulation of Software as a Medical Device (SaMD)

The FDA’s evolving framework for software-based medical products affects companies far beyond traditional medical device manufacturers. Clinical decision support software, AI/ML diagnostic tools, remote patient monitoring platforms, and certain wellness applications may qualify as medical devices subject to FDA premarket review. We help clients (1) classify their products under the FDA’s risk-based framework (Class I, II, III), (2) navigate 510(k) clearance, De Novo classification, or PMA approval pathways, (3) implement the FDA’s Predetermined Change Control Plan (PCCP) framework for AI/ML-enabled devices, (4) maintain Quality System Regulation (21 CFR Part 820) compliance, and (5) manage post-market surveillance, MDR reporting, and FDA inspection readiness.

Telehealth Licensing, Prescribing, and Cross-State Practice

Telehealth platforms must navigate state-by-state physician licensing, the Ryan Haight Act for online prescribing of controlled substances, Drug Enforcement Administration registration, state-specific telehealth practice standards, and the post-pandemic regulatory landscape that continues to evolve. We advise telehealth providers, hybrid in-person/virtual care platforms, asynchronous care companies, and direct-to-consumer prescription services on platform structure, provider contracting, corporate practice of medicine restrictions (where applicable), and the operating compliance program needed to scale across multiple states.

Consumer Health Data Privacy Beyond HIPAA

Many digital health products fall outside HIPAA’s scope (because they don’t involve a covered entity) but are still subject to consumer health privacy regimes that are often more aggressive than HIPAA itself. Washington’s My Health My Data Act, Connecticut’s data privacy act with its consumer health data carve-out, the FTC’s Health Breach Notification Rule, and California’s Confidentiality of Medical Information Act each impose distinct requirements on consumer health data collection, use, and sharing. State-level enforcement against femtech apps, mental health platforms, and consumer genomics companies has accelerated. We help clients map their data flows against this patchwork and design privacy notices, consent mechanisms, and data minimization practices that meet the most demanding standard.

AI and Machine Learning in Healthcare

AI-powered clinical tools, diagnostic algorithms, and care management platforms sit at the intersection of FDA SaMD regulation, HIPAA, state medical practice law, and emerging AI-specific regulation (the EU AI Act, state-level AI laws including Colorado’s AI Act and the EU AI liability framework). Key issues include training data licensing and HIPAA compliance, model bias and discrimination liability, intellectual property in fine-tuned models, professional liability and malpractice exposure for AI recommendations, and the rapidly evolving regulatory framework for generative AI in clinical settings.

Common Transactional Matters

Beyond regulatory compliance, healthtech companies frequently need transactional counsel: venture financing and SAFE rounds for early-stage digital health startups, licensing arrangements with hospital systems and payors, partnership structures with traditional providers, M&A diligence and integration (which always includes HIPAA, FDA, and consumer privacy diligence), and the IP protection strategies (patent and trade secret) that protect proprietary algorithms and data assets.

Frequently Asked Questions

Is my health app subject to HIPAA? Only if you receive PHI from or on behalf of a HIPAA covered entity (a healthcare provider, health plan, or healthcare clearinghouse). Many consumer-facing health apps that collect health data directly from users are not HIPAA business associates — but they’re typically subject to the FTC Health Breach Notification Rule, state consumer health privacy laws, and general consumer protection requirements.

When does my software become a medical device under FDA jurisdiction? The FDA looks at intended use, the type of decision the software supports, and whether a clinician can independently evaluate the basis for the recommendation. Software that “diagnoses, treats, or prevents disease” is generally a medical device. The FDA has issued guidance on clinical decision support, wellness products, and AI/ML-enabled devices to help draw these lines.

Can my telehealth platform operate in all 50 states? Yes, with the right structure. The provider network must be licensed in each state where it serves patients, the platform must comply with each state’s telehealth practice standards, and prescribing controlled substances triggers DEA registration requirements. We routinely help platforms scale state-by-state and design the corporate structure (including PC/PA management services organization models where required).

How does my company protect against state consumer health privacy claims? The most defensible posture is a privacy program built to the most demanding state standard (currently Washington’s My Health My Data Act for consumer health data) with documented data flow mapping, consent mechanisms, and vendor management. We help clients design this program once and apply it across jurisdictions.