New Data Regulations and Their Impact on Compliance, Care Quality, and Patient Safety
As of 2025 GDPR, new regulatory updates to UK GDPR and broader EU frameworks have introduced significant changes in how healthcare organisations—including care homes, social care providers, GP practices, and private clinics—must handle and protect personal data.
With the stakes higher than ever, organisations must act now to ensure compliance and continue delivering safe, person-centred care.
Key GDPR-Related Changes in 2025
- The UK’s Data Use & Access Act (DUAA)
In June 2025, the Data Use & Access Act came into force, amending the UK GDPR and Data Protection Act 2018. This includes:
- The creation of a new regulatory body: the Information Commission (replacing the ICO)
- A legal obligation to respond to Data Subject Access Requests (DSARs) in a “reasonable and proportionate” manner
- Broader powers for future rules on processing health and biometric data
- Tighter Regulations on AI and Automated Decisions
Health and social care providers increasingly use AI for scheduling, fall prediction, medication tracking, and risk analysis. Under 2025 updates:
- Individuals have enhanced rights around automated decision-making
- Providers must offer meaningful explanations and human oversight for care-related AI tools
- Data Sharing & Transfers
There is increased scrutiny around data transfers outside the UK and EU.
- Transfer Impact Assessments (TIAs) and contractual protections must be in place
- Cloud-based care platforms must now document how personal data is protected cross-border
- European Health Data Space (EHDS)
Although an EU regulation, the EHDS impacts UK organisations sharing patient data with EU services. It mandates:
- Standardisation of electronic health data
- Data portability and secure cross-border interoperability
- Advanced pseudonymisation and encryption measures for patient records
Implications for Healthcare, Social Care & Care Home Providers
These regulatory changes have direct operational and legal consequences:
- Broader definitions of sensitive health data (including genetic, biometric, behavioural data)
- Tighter consent processes for service users and patients
- Increased accountability in data security measures, particularly for cloud systems like eMAR, digital care plans, and mobile apps
- Expectation of robust governance around AI-supported decision-making in care delivery
- Heightened enforcement risk:
- In 2024, average healthcare-related GDPR penalties in Europe translated to over £175,000, with some organisations facing fines above £2.6 million
How Cognito Consultants Helps Providers Stay Compliant & Safe
At Cognito Consultants, we support providers across health and social care in achieving GDPR compliance while improving operational quality and care outcomes.
- Governance, Risk & Compliance (GRC) Frameworks
- Update policies, consent forms, privacy notices, and DSAR protocols in line with DUAA
- Align documentation with the latest guidance on AI, data sharing, and record retention
- Prepare for inspections with tailored mock audits and compliance reviews
- Technical & Organisational Measures (TOMs)
- Help you implement appropriate data protection controls: encryption, access restriction, cloud storage policies, and breach response
- Review your digital platforms (e.g., Birdie, PASS, CareLineLive) to ensure data minimisation and GDPR compliance
- AI & Decision-Making Oversight
- Support for risk assessments around AI and automated tools in care planning or medication systems
- Create governance protocols that protect patients’ rights and ensure transparency
- Interoperability & Cross-System Readiness
- Guidance on cross-border data transfer compliance
- Preparing organisations for EHDS standards, including pseudonymisation and digital record sharing
- Staff Training & Culture Development
- Deliver GDPR and data protection training for care teams, managers, and support staff
- Build a culture of data privacy and patient safety aligned with regulatory expectations
Compliance Isn’t Just About Avoiding Fines – It’s About Better Care
By embedding GDPR compliance into daily practice, care providers can:
- Build stronger trust with clients, patients, and families
- Improve the quality and accuracy of care documentation
- Avoid reputational and financial risk
- Future-proof their services against evolving digital and regulatory expectations
Cognito Consultants: Your Trusted Partner in Care Compliance
Whether you’re running a residential care home, community care service, private clinic or digital-first health model, our team can help you:
- Conduct a full GDPR compliance review
- Train and upskill your team on best practices
- Implement safe, secure systems that enhance both care quality and operational efficiency
For a conversation about how the 2025 changes affect your service—and what you can do to stay compliant while putting patient safety first—get in touch with us today.