Digital Health
Smart Tech, Sound Law
Connected. Protected. Compliant.
Gardner Law helps digital health companies navigate the evolving legal landscape at the intersection of software, data, and medical innovation. Whether you're developing mobile medical apps (MMA), AI-enabled diagnostics, telehealth platforms, clinical decision support (CDS) tools, or software as a medical device (SaMD), our attorneys provide targeted legal counsel to help you stay compliant and competitive. We advise clients on regulatory pathways including FDA premarket submissions, privacy and cybersecurity, interoperability, advertising, and labeling.
Our team also supports clients in structuring compliant relationships with healthcare providers, managing data use and consent under HIPAA and state laws, and preparing for government enforcement or litigation. As technology reshapes care delivery, Gardner Law delivers clarity and confidence in the complex world of digital health.
Representative Matters Include:
- FDA regulatory strategy and submission support for Software as a Medical Device (SaMD), including 510(k), De Novo, and Pre-Submissions
- Regulatory assessments and opinions on software classification and applicable regulatory pathways
- Strategy and preparation for FDA meetings and communications
- Advising on mobile medical applications (MMA), clinical decision support software (CDS), and AI/ML-based medical devices
- Drafting and negotiating Software Development Agreements, Data Use Agreements, and Cloud Service Agreements
- Advising on interoperability, FDA’s guidance on software modifications, and real-world evidence use
- Privacy and cybersecurity compliance counseling under HIPAA, HITECH, GDPR, and state laws
- Audit and assess privacy and cybersecurity
- Setup and manage HIPAA compliance and privacy programs
- Draft and negotiate business associate agreements
- Prepare website, software, and mobile application terms
- Review and advising on website and mobile app terms of use, privacy policies, and data collection practices
- Advising on Business Associate Agreements (BAAs) and data sharing agreements
- Digital advertising and promotional review for software and digital health solutions
- Due diligence review of digital health assets in M&A, investment, or licensing deals
- Counseling on FDA and FTC advertising compliance for health-related software and apps
- Compliance audits, investigations, and training related to digital health operations
- Review of AI explainability, validation, and documentation for regulatory and legal risk management
- Litigation and enforcement action defense related to data breaches, false claims, or misrepresentation of software functionality
- Advising on use of patient-generated health data, remote monitoring data, and integration with electronic health records (EHRs)
- Counseling on integration of digital health products into reimbursement pathways, including CMS coverage