BRACE Law Firm provides legal support to companies operating at the intersection of medicine and technology: medical software and artificial intelligence developers, telemedicine platforms, wearable device and remote health monitoring solution manufacturers, digital divisions of Life Sciences companies, healthcare providers, and healthcare investors.

Digital healthcare products simultaneously fall under the regulation of medical device circulation, healthcare laws, data privacy, and information laws, and, starting in 2025, the emerging rules for artificial intelligence usage. We help structure the product and business model to ensure simultaneous legal compliance and resilience across all these regulatory frameworks.

Core Areas of Digital Health and AI Legal Counsel

1. Telemedicine – We advise healthcare providers and telemedicine platforms on selecting the appropriate operational model (general regime or participation in an Experimental Legal Regime), and we draft internal policies, patient and physician agreements, informed consent forms, and documentation for Roszdravnadzor audits.
2. Medical Software (SaMD, Software as a Medical Device) – Navigating the regulatory landscape for standalone software with medical purposes (diagnostics, prevention, monitoring, treatment), which qualifies as a medical device under specific conditions and requires state registration.
3. Data Privacy and Medical Confidentiality – Conducting audits of medical data processing workflows, we draft privacy policies and consent forms, build the contractual architecture (data processing agreements, non-disclosure agreements), and provide strategic guidance regarding data localization, cross-border transfers, and data anonymization for AI training.
4. AI-Enabled Medical Devices and Clinical Decision Support Systems (CDSS) – Handling the software qualification process, we select the optimal registration pathway and risk class, prepare the registration dossier and technical documentation, manage interactions with testing laboratories and Roszdravnadzor, and oversee post-market compliance obligations (monitoring, modification implementation).
5. Personal Medical Assistants, Wearable Devices, and Remote Monitoring Solutions – Counseling clients on regulatory requirements for hardware and services that collect and transmit health data.
6. mHealth Applications, Appointment Booking Platforms, Healthcare Aggregators, and Electronic Prescription Services – Mitigating legal risks that arise precisely at the boundaries of these categories. For example, a "health and wellness" app may inadvertently transition into a medical device status, or an "information service" might begin providing de facto medical care. One of our primary objectives is to accurately qualify the product and determine the applicable legal regime prior to market launch.

Legal Representation for Telemedicine and Remote Healthcare Services

1. Structuring the legal qualification of the service (medical care vs. information service) and selecting the operational model.
2. Evaluating the feasibility and procedure for participating in an Experimental Legal Regime (ELR).
3. Drafting telemedicine care protocols, physician and patient agreements, and informed consent forms.
4. Managing the medical licensing process, specifically accounting for the telemedicine component.

Legal Counsel for Medical Software and AI (SaMD / AI-Enabled Medical Devices)

1. Qualifying the software as a medical device and determining the applicable risk class.
2. Selecting the appropriate registration pathway (National or EAEU) and formulating the market entry strategy.
3. Preparing the registration dossier, managing technical, toxicological, and clinical trials, and facilitating engagement with Roszdravnadzor.
4. Ensuring ongoing compliance with mandatory requirements for AI devices, including data transmission to the Roszdravnadzor information system and managing product modifications.

Legal Support for Data Privacy and Medical Confidentiality

1. Auditing the processing of medical and other personal data.
2. Developing privacy policies, consents, and internal corporate regulations.
3. Advising on data localization, cross-border transfers, and anonymization, including data used for training AI models.
4. Assessing risks and establishing a comprehensive compliance framework to mitigate the threat of revenue-based fines and criminal liability.

AI Compliance and Legal Risk Management

1. Creating internal policies for the responsible and ethical use of artificial intelligence.
2. Allocating liability and defining zones of responsibility among the developer, the operator, and the healthcare provider.
3. Conducting legal assessments of algorithmic transparency, documentation practices, and quality control for AI solutions.

Commercial Contracts and Intellectual Property

1. Negotiating and drafting software licensing and assignment agreements, development contracts, Service Level Agreements (SLAs), and agreements with healthcare providers and distributors.
2. Structuring legal rights to datasets and model training outputs, alongside safeguarding trade secrets and know-how.
3. Establishing IP frameworks for deliverables generated through the use of artificial intelligence.

Regulatory Strategy and Government Relations

1. Performing regulatory due diligence on products and business models to establish a compliance roadmap.
2. Facilitating participation in Experimental Legal Regimes and managing communications with regulatory authorities.
3. Structuring venture investments and M&A transactions within the HealthTech sector, and securing tax and industry incentives for IT and med-tech companies.

Advertising, Marketing, and Consumer Protection

1. Executing legal reviews of advertising and marketing campaigns for digital healthcare services, ensuring strict compliance with advertising laws and mandatory internet advertising labeling requirements.
2. Drafting Terms of Service, End-User License Agreements (EULAs), public offers, and consumer protection documentation tailored for digital platforms.

Dispute Resolution and Audit Defense

1. Representing clients during inspections and audits conducted by Roszdravnadzor, Roskomnadzor, and the Federal Antimonopoly Service (FAS) of Russia.
2. Litigating and resolving disputes related to digital healthcare products, software, and data privacy.

Representative Matters in Digital Health and AI

1. Conducted comprehensive regulatory due diligence for a major international medical device manufacturer to determine if a software product required registration as a medical device, providing strategic recommendations to minimize regulatory risks prior to market launch.
2. Advised a prominent domestic player in the telemedicine market on delineating medical care from information services, drafting the necessary documentation to comply with Ministry of Health and Roszdravnadzor regulations.
3. Counseled a leading Russian manufacturer of original pharmaceutical products on processing medical data in compliance with personal data laws and medical confidentiality requirements, specifically mitigating risks associated with heightened liability frameworks.
4. Structured a cross-border investment and M&A transaction between Russian and Chinese medical device manufacturers concerning the funding, acquisition, and localization of a medical device incorporating a digital health product.

Why Choose BRACE?

1. Digital healthcare products rarely fit neatly into a single branch of law, which is precisely why their legal support requires a team that operates with equal confidence in both healthcare regulation and technology law.
2. BRACE Law Firm possesses deep industry expertise in Life Sciences (pharmaceuticals, medical devices) and the Technology, Media, and Telecommunications (TMT) sector. This cross-disciplinary proficiency allows us to manage intersecting projects comprehensively: from product qualification and registration to data privacy, commercial contracts, and audit defense.
3. We continuously monitor the rapidly evolving legislative landscape and deliver practical, actionable solutions designed to achieve our clients' business objectives.
4. Our attorneys advise domestic and international companies on Russian and, when necessary, international law.