Safety & Risk Management

Risk Management Process (Public Summary)

Scope This process covers clinical and safety risks related to our digital health content and features (e.g., exercise guidance, chat, notifications) and supporting infrastructure.

Governance Our Clinical Safety Officer (CSO) is Andrew C. Gorecki (also our DPO). The CSO oversees risk management, approves safety policies, and reviews incidents/adverse events.

Approach: We maintain a risk management system informed by recognized standards for digital health safety (e.g., ISO 14971/ISO 31000 principles). It includes:

Identification: We collect potential hazards from design reviews, clinician input, testing, user feedback, and production monitoring.

– Analysis & Evaluation: We rate risks by severity and likelihood, prioritize higher risks, and document rationales.

– Controls & Mitigations: We implement content vetting by qualified professionals, safety warnings in-app, guided progressions, “stop if pain” prompts, environment/surface checks, and technical controls (e.g., authentication, rate limiting, monitoring).

– Residual Risk & Acceptance: The CSO reviews whether residual risks are acceptable given mitigations and intended use.

– Post-Market Surveillance: We monitor safety signals (e.g., user feedback, error logs), review trends, and update controls. Formal reviews occur at least every 6 months or after material changes.

– Incident Management: We triage, contain, investigate, document, and (where required) notify users/authorities. See our “Data Breach Response & Notification” and “Important Safety Information & Risks”

Documentation. We maintain a safety case dossier and risk register; summaries are available on request.

Important Safety Information & Risks

– Not emergency care. The app is not for emergencies. If you experience severe pain, shortness of breath, chest pain, signs of stroke, or another emergency, call 911 (or your local emergency number) immediately.

– No medical diagnosis or treatment advice. Content is educational and does not replace advice from your own healthcare professional. Always consult a qualified professional before starting a new exercise program, especially if you have medical conditions, recent surgery, or concerns about symptoms.

– Exercise risks. Physical activity carries risks of injury or symptom flare-up. Use a clear, non-slip area; wear appropriate footwear; progress gradually; stop if you feel pain, dizziness, or unusual symptoms; and contact a clinician if symptoms persist.

– Suitability & modifications. Not all exercises are appropriate for everyone. Follow modifications as instructed and only within your comfort and ability.

– Supervision. Minors should use the app only with appropriate adult supervision. Some users may require in-person guidance from a clinician.

– Device & connection limits. Performance can be affected by device settings, battery, sensors, and connectivity. Notifications and messages may be delayed and are not a substitute for urgent care.

– Accuracy & completeness.*We strive to ensure accuracy, but content may not reflect every individual case or the most recent clinical developments. Always rely on your clinician’s guidance first.

– Report concerns or adverse events. If you experience an injury, adverse event, or safety concern related to the app, contact our Clinical Safety Officer using the details below.

Clinical Safety Officer (CSO): Andrew C. Gorecki — support@mymovementrx.com — (231) 944-6541