Trusted credentials
At a glance
HIPAA and GDPR Compliant
HIPAA (Health Insurance Portability and Accountability Act) protects sensitive patient health information in the US. GDPR (General Data Protection Regulation) governs the collection and processing of personal data in the UK and EU. The Able Platform meets all HIPAA and GDPR requirements.
ISO 27001 Certified
ISO 27001 is the international standard for implementing Information Security Management Systems (ISMS). GripAble LTD has been certified against ISO 27001 by the British Standards Institution (BSI).
FDA registered
The GripAble Sensor is registered and listed with the US Food and Drug Administration (FDA) as a Class II exempt medical device (Product Codes: ISD / LBB). The Able Rehab products (GripAble Pro / Home) are also registered and listed with the FDA as Class II exempt medical devices (Product Codes: QKC / ISD). The Able Assess software separately meets all four criteria for Non-Device Clinical Decision Support Software (CDS).
FDA registration does not imply FDA clearance or approval.
Regulatory and compliance detail
FDA Registered
The GripAble Sensor and the Able Rehab products (GripAble Pro and GripAble Home) are registered and listed with the U.S. FDA as Class II exempt (not FDA clearance or approval), with product codes ISD / LBB / QKC. The Sensor utilises an FCC-authorised wireless module (Contains FCC ID: SH6MDBT50Q). The Able Assess software separately meets all four criteria for Non-Device Clinical Decision Support Software (CDS).
ISO 27001 Certified
Able Care holds ISO/IEC 27001 certification, issued by BSI (British Standards Institution), for its information security management system. This internationally recognised 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 Aligned
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 and audit logging. We execute Business Associate Agreements (BAAs) with applicable customers, which address breach-notification responsibilities.
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 our sub-processors. Data subjects can exercise their rights to access, rectification, erasure and portability through documented procedures.
CDC STEADI Aligned
Able Assess aligns with the CDC STEADI (Stopping Elderly Accidents, Deaths and Injuries) initiative on falls assessment and prevention. The platform supports the recommended multifactorial risk-assessment approach by capturing objective functional measures central to falls prevention in older adults. Such alignment indicates consistency of approach only and does not imply endorsement or affiliation by the CDC.