Everything you need to know about Docwise's regulatory, clinical, and data-security standards – clearly explained for NHS and UK healthcare teams.
GDPR
(General Data Protection Regulation)
GDPR is the UK and EU’s comprehensive data protection law governing how personal data is collected, processed, stored, and protected. Docwise is fully GDPR compliant, implementing robust data protection measures including encryption, clear consent mechanisms, and user rights to access or delete their data. All patient data is stored securely within UK-based servers, ensuring data sovereignty and privacy protection.
UKCA
(UK Conformity Assessed)
UKCA marking demonstrates that a product meets UK safety, health, and environmental protection requirements for products sold in the UK. Docwise holds UKCA certification, confirming compliance with all applicable UK regulatory requirements for medical device software used in healthcare settings.
The ICO is the UK’s independent regulator for data protection and information rights. Docwise is registered with the ICO, confirming our legal status as a data controller and our commitment to upholding UK data protection laws in handling patient health data.
NHS DTAC
(Digital Technology Assessment Criteria)
The NHS DTAC is a comprehensive framework used to evaluate digital health technologies for use within the NHS, assessing clinical safety, data protection, technical security, interoperability, and usability standards. Our DTAC compliance demonstrates that Docwise has been assessed against rigorous standards for clinical effectiveness, information governance, and technical assurance required for NHS procurement.
The NHS DSPT is mandatory for all organizations with access to NHS patient data and sensitive information. Docwise maintains an active ‘standards met’ DSPT status, ensuring continuous compliance with NHS data security requirements.
Cyber Essentials is a UK government-backed cybersecurity certification verifying essential security controls including firewalls, secure configuration, user access control, malware protection, and security updates. Docwise is Cyber Essentials certified, demonstrating commitment to fundamental cybersecurity across all systems and infrastructure.
DCB0129
(Clinical Risk Management)
DCB0129 is a mandatory NHS Digital standard establishing clinical risk management requirements for health IT systems deployed in NHS settings. Docwise is fully compliant with DCB0129, having completed comprehensive clinical risk management activities including hazard identification and risk assessment.
The MHRA regulates medical devices in the UK, with Class I representing low-risk devices meeting essential safety and performance requirements. Docwise is registered with the MHRA as a Class I medical device, confirming compliance with regulatory requirements for medical device software used in UK healthcare settings.