Compliance & Regulatory Status.
Able Assess meets stringent regulatory and data protection requirements across the US and UK.
Trusted credentials
Regulatory and compliance detail
FDA Listing
Able Assess is registered with the US Food and Drug Administration as a Class I medical device. FDA listing confirms that the device has been registered with the agency, that the manufacturer complies with establishment registration and device listing requirements, and that the product meets applicable performance standards. Class I devices are subject to general controls including good manufacturing practices and adverse event reporting.
CE Marking
The CE mark confirms that Able Assess meets EU health, safety and environmental protection standards. This allows the product to be marketed and sold across the European Economic Area. Conformity assessment has been completed in accordance with the applicable Medical Device Regulation (MDR) requirements.
ISO 27001
Able Care holds ISO 27001 certification for its information security management system. This internationally recognized standard requires documented policies, risk assessments and controls covering data confidentiality, integrity and availability. Certification is maintained through annual surveillance audits conducted by an accredited certification body.
HIPAA Alignment
Able Assess is designed to support HIPAA compliance for covered entities and business associates in the United States. Technical safeguards include encryption at rest and in transit, role-based access controls, audit logging and breach notification procedures. We execute Business Associate Agreements (BAAs) with all applicable customers.
GDPR Compliance
For UK and EU customers, Able Care processes personal data in accordance with the General Data Protection Regulation (GDPR) and the UK Data Protection Act 2018. Data processing agreements are in place with all sub-processors. Data subjects can exercise their rights to access, rectification, erasure and portability through documented procedures.
NICE 2025 Alignment
Able Assess aligns with the National Institute for Health and Care Excellence (NICE) 2025 guidelines on falls assessment and prevention. The platform supports the recommended multifactorial risk assessment approach, capturing objective functional measures that NICE identifies as central to falls prevention in older adults.