OPP_ALS_003 📄 Overview A SaMD platform enabling remote tele-rehabilitation exercises, symptom tracking (ePROs), and cognitive assessments for ALS patients. The interface would dynamically adapt to the patient's progressive motor and speech impairment, utilizing eye-tracking, voice commands, or large-button touchscreens as needed. This reduces the need for clinic visits for assessments and allows patients to participate in therapeutic interventions from home, providing continuous feedback on functional status and quality of life. Key technologies: 👤 Target users: 👍 Benefits Reduced patient burden and travel costs • Improved adherence to rehabilitation protocols • More frequent and consistent capture of PROs • Objective assessment of functional changes in the home setting • Enhanced patient engagement and sense of control Use bullets or new lines. 👎 Challenges Ensuring equitable access to necessary hardware (e.g., eye-tracking devices) • Training for patients and caregivers on technology use • Validating ePRO instruments for remote use • Integration with clinician workflows and EHRs • Maintaining engagement as disease progresses 📋 Regulatory & Validation The platform's assessment features would likely be SaMD (Class I/II), requiring validation. • Privacy of telehealth interactions and personal health data (HIPAA, GDPR). • Digital therapeutic components may require separate regulatory clearance.