Connected Health & Medical Devices at Home.

Remote monitoring, digital therapeutics, and patient data outside the hospital walls

The home is rapidly evolving into a center for health, wellness, and lifestyle innovation—a shift championed by the FDA’s “Home as a Healthcare Hub” initiative. From smart fitness trackers and meditation apps to advanced sleep monitors, remote blood pressure and ECG devices, and continuous glucose monitoring, technology is empowering consumers, patients, and physicians to proactively manage health in familiar surroundings. As connectivity and user interfaces improve, both general wellness tools and traditional medical devices are increasingly accessible at home, enabling earlier detection of disease, improved monitoring, and enhanced patient-provider interaction for better outcomes.

How we support our clients

Our medical device team partners with companies at every stage of their journey, from concept to commercialization. We help clients analyze product features, intended uses, and marketing strategies to determine regulatory pathways and business cases. Whether you’re developing a general wellness product or a regulated medical device, we provide strategic guidance to separate lifestyle features from health-related claims, manage regulatory submissions, and align product development with compliance and reimbursement goals. Our comprehensive support covers everything from distribution contracts and quality agreements to state licensing and ongoing regulatory compliance.

Areas of focus

Commercialization & Regulatory Compliance

Providing strategic analysis of product features, intended uses, and claims
Proving guidance on regulatory submissions (510(k), De Novo, PMA)
Supporting on documentation, testing, and market entry

Wellness Product Strategy

Crafting claims and marketing materials to build market share and brand loyalty while avoiding premature regulatory obligations

Medical Device Promotion & Advertising

Developing robust procedures for claims, advertising, and promotion
Conducting compliance audits and training
Responding to enforcement actions

Privacy & Cybersecurity

Implementing safeguards for sensitive health data
Advising on HIPAA, GDPR, and other regulations
Providing risk assessments and incident response planning

Coverage & Reimbursement

Advising on strategies to maximize payer acceptance
Aligning claims and evidence generation with reimbursement requirements
Providing coding and billing support for wellness and medical device functions

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Delivering results

A client developing a continuous glucose monitoring device for home use sought to expand market access while ensuring regulatory compliance. Hogan Lovells’ medical device team worked closely with the client to analyze product features and intended uses, crafting claims and marketing materials that clearly distinguished wellness functions from regulated medical device capabilities. We guided the client through the 510(k) submission process, advised on data collection and testing requirements, and helped align reimbursement strategies with payer expectations. Our support extended to privacy and cybersecurity documentation, ensuring compliance with HIPAA and GDPR. As a result, the client successfully launched their product, secured regulatory clearance, and achieved broad market acceptance—empowering patients to manage their health confidently at home.

Key Contacts

Lina Kontos

Partner Global Regulatory

Jodi Scott

Partner Global Regulatory