Healthcare technology companies handle vast amounts of health data every day. Protecting this information isn't just good practice—it's the law.
The General Data Protection Regulation (GDPR) has strict rules about managing personal data, with hefty fines for companies that don't comply.
Starting with GDPR compliance can feel hard, but splitting it into manageable steps simplifies the process and makes achieving compliance easier.
In today's article, we will give you a structured GDPR compliance checklist to help you track your progress and show your commitment to protecting health data.
It will keep you on the right side of regulations and help you build trust with your patients and partners.
What is GDPR compliance in healthcare?
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The General Data Protection Regulation (GDPR) is a privacy law that affects healthcare organizations handling data of individuals in the European Union and European Economic Area.
Even if your healthcare company is based outside the EU, you must follow GDPR if you offer services to EU citizens or monitor their behavior.
Healthcare organizations deal with medical records, treatment information, biometric and genetic data.
GDPR compliance means protecting health data while following specific rules about how you collect, store, and use this information, including personal data processing.
The regulation is built on key data protection principles such as lawfulness, fairness, transparency, purpose limitation, and data minimization.
According to GDPR Article 83(5), non-compliance can result in fines of up to €20 million or 4% of global annual revenue, whichever is higher.
Why is GDPR compliance important in healthcare?
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Beyond fines, the reputational damage from GDPR violations can be devastating. Patients trust you with their most private information, and breaking that trust is hard to recover from.
Data protection authorities are key in ensuring compliance with data protection laws, especially for organizations processing large-scale data or operating within the EU.
The complete GDPR compliance checklist
Meeting GDPR requirements in healthcare technology demands a systematic approach focusing on health data protection while maintaining operational efficiency.
Following these steps will enable your organization to ensure compliance and build trust with both patients and partners.
Step 1: Determine GDPR applicability
Verify if GDPR applies to your healthcare technology company. The regulation affects organizations that:
- Process personal data of EU/EEA residents (regardless of your location)
- Have an establishment in the EU/EEA (an office or other fixed place)
- Offer goods or services to EU/EEA residents (like telehealth or electronic health record solutions)
- Monitor EU/EEA residents' behavior (analyzing health trends or user engagement on digital platforms)
You do not need to meet all these criteria; fulfilling any one or more can bring your organization within the scope of GDPR. Check if you process special categories of data like health records, genetic data, or biometric data. GDPR Article 9 demands extra protection.
Document your assessment to demonstrate compliance efforts. It helps if you ever need to justify your GDPR implementation approach.
Step 2: Create a healthcare data inventory
Image source: The HIPAA Journal
Map all personal data your organization processes. This inventory should identify:
- What types of health data you collect
- Why you collect each data element
- Where data is stored (including third-party systems)
- How long you retain different types of data
- Who has access to the data
- Data flows between systems and organizations
It serves as a detailed record of your GDPR compliance practices, providing actual proof of compliance during audits or in the event of a data breach.
For healthcare tech, this includes patient records, diagnostic data, billing information, and staff data. Don’t forget less obvious sources like website analytics, marketing databases, and research data.
Create visual data flow diagrams to understand how information moves through your systems. It helps identify potential risk points.
Your inventory forms the foundation for a comprehensive Record of Processing Activities – a key GDPR requirement for most organizations.
Step 3: Establish a lawful basis for processing health data
Identify and document the legal basis for processing data, including each type of healthcare data. Under GDPR Article 9, you must have one of these bases:
- Explicit consent from the patient
- Necessity for medical diagnosis or treatment
- Public health interests
- Vital interests of the data subject
- Performance of a contract
- Legitimate interests of your organization
For health data, explicit consent is often preferred but not always required. Medical necessity or public health purposes may provide a sufficient basis in healthcare settings.
Be cautious with legitimate interests – you must conduct a balancing test weighing your interests against patient privacy rights under Article 6(1)(f)).
Document your reasoning for each processing activity and keep evidence of consent where applicable. Review these bases annually or when processing changes.
Step 4: Implement user rights procedures
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Based on Articles 12-23, create clear procedures for handling patient requests to exercise their GDPR rights, including data subjects rights, such as:
- Right to access their data
- Right to correct inaccurate information
- Right to erasure (“right to be forgotten”)
- Right to restrict processing
- Right to data portability
- Right to object to processing
Develop templates for responding to these requests. Build technical capabilities to extract, modify, or delete specific patient data without disrupting your entire system.
Establish verification procedures to confirm the identity of individuals making requests. It prevents unauthorized access to sensitive health information.
Set reasonable timeframes for response (typically within one month). Document all requests and your responses to demonstrate compliance.
Train frontline staff to recognize and properly route these requests to your privacy team.
Step 5: Update privacy notices and policies
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Create comprehensive privacy notices in clear and plain language. Your notices should include:
- Your identity and contact details
- Types of health data collected
- Purposes for processing
- Legal basis for each processing activity
- Data retention periods
- Patient rights under GDPR
- Information about international transfers
- Automated decision-making processes
Consider creating layered notices – a simplified overview with links to more detailed information.
Test your notices with actual users to ensure comprehension. Avoid legal jargon that confuses patients.
Make privacy notices accessible across all platforms, including your website, mobile apps, and patient portals.
Update them whenever your data practices change.
Step 6: Establish DPO requirements and governance
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Determine if your healthcare technology company needs a Data Protection Officer. Under GDPR Article 37, a DPO is mandatory if you:
- Process large volumes of health data
- Regularly monitor individuals systematically
- Are a public authority
According to GDPR Articles 38 and 39, the DPO role requires data protection law and practices expertise. They must operate independently and report directly to top management. Read our article to learn more about the difference between GDPR representatives and DPOs.
If required, you can:
- Appoint an internal DPO (with proper qualifications)
- Hire an external DPO service
- Share a DPO with other organizations
Establish clear responsibilities for your DPO, including:
- Monitoring GDPR compliance
- Advising on data protection impact assessments
- Cooperating with supervisory authorities
- Acting as a contact point for data subjects
Document your decision-making process about DPO requirements to demonstrate compliance consideration.
Step 7: Conduct data protection impact assessments
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Perform Data Protection Impact Assessments (DPIAs) for high-risk processing activities related to sensitive data:
- New technology implementations
- AI or machine learning systems analyzing health data
- Large-scale processing of health data
- Genetic or biometric data processing
- Data sharing with third parties
According to Article 35 of the GDPR, your DPIA should:
- Describe the processing operations
- Assess necessity and proportionality
- Identify and evaluate risks to individuals
- Define measures to address those risks
Involve your DPO in the DPIA process from the beginning. Document all findings and decisions made.
Implement DPIA results before launching new products or services. This “privacy by design” approach prevents costly remediation later.
Review existing products periodically to determine if new DPIAs are needed as technology or processing evolves.
Step 8: Implement data security measures
Strong data security is necessary to achieve GDPR compliance.
Based on Article 32, maintaining technical security measures is crucial to protect personal data and prevent vulnerabilities:
- Access controls with role-based permissions
- End-to-end encryption for data in transfer and at rest
- Anonymization techniques for data used in research
- Regular penetration testing and vulnerability assessments
Create a formal data protection policy that outlines how you safeguard personal data. Review and update this policy regularly as technology and threats evolve.
Step 9: Develop a breach notification protocol
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According to Article 33, your policy must enable you to detect and report data breaches without undue delay.
Your breach notification protocol should include:
- A breach identification mechanism
- A severity assessment framework
- Templates for notifying affected data subjects
- Procedures for reporting to the relevant supervisory authority
Have clear procedures in place to delete personal data upon request.
Document everything during a breach response. Keep records of what happened, your response actions, and communications with authorities and affected individuals.
Train your employees to recognize potential breaches and understand their reporting responsibilities.
Conduct regular simulations to test your response plan’s effectiveness.
Step 10: Address international data transfers
If your services go beyond the EU/EEA, you must have explicit rules for international data transfers.
The GDPR has strict regulations about sending personal information out of the European Economic Area, and you need to have the right safety measures in place to do so legally (Articles 45 to 49).
Consider these compliance approaches:
- Implement Standard Contractual Clauses (SCCs)
- Pursue Binding Corporate Rules for intra-group transfers
- Check if your destination country has an adequacy decision from the EU Commission
Pay particular attention to health data flowing to cloud services, offshore development teams, or international research partners. Map these data flows carefully.
Create a visual diagram showing where your data travels internationally. This documentation helps demonstrate compliance and identifies potential risk areas that require attention.
Step 11: Create required documentation
Develop and keep mandatory GDPR documentation, including:
- Records of processing activities (RoPAs)
- Data protection policies and procedures
- Privacy notices and consent forms
- Data protection impact assessments
- Data breach response plans
- Data transfer mechanisms
Organize documentation in a central repository that key staff can access. Consider using compliance management software to keep track of review dates and versions.
Regular documentation reviews (at least annually) ensure continued compliance as regulations and your business evolve. It creates a clear audit trail of your compliance efforts.
Step 12: Create a vendor management program
Your healthcare technology company likely works with numerous vendors who process data on your behalf. As the data controller, you remain responsible for how these data processors handle information.
Your vendor management program should include:
- Due diligence assessments before the partnership
- Data processing agreements with clear responsibilities
- Regular compliance audits of vendor practices
- Termination clauses for non-compliance
Maintain a register of all vendors with access to personal data. Record what data they can access, why they need it, and what security measures they've implemented to protect it.
Review vendor relationships annually to ensure they continue to meet GDPR requirements. Document these reviews as evidence of ongoing compliance efforts.
Step 13: Implement a staff training program
Your employees are your first line of defense in protecting health data privacy. Regular training helps create a culture of compliance throughout your organization.
Implementing these practices ensures lawful data handling, maintains accountability, and protects the privacy rights of individuals.
Your training program should cover:
- GDPR fundamentals relevant to healthcare
- Data protection principles and their practical application
- Recognizing and handling data subject rights requests
- Security best practices for daily operations
Make training interactive and relevant to specific roles. Developers, customer service teams, and marketing staff have different data-handling responsibilities.
Test comprehension after training sessions and provide refresher courses quarterly. Document all training activities with new data security practices as evidence of your compliance efforts.
Step 14: Establish GDPR compliance monitoring
Implement systems to track and verify your compliance status.
Provide clear and accessible information about data rights and processing specifically for certain audiences.
Systematic monitoring activities include:
- Regular internal audits of data processing activities
- Automated scanning for unauthorized data access
- Periodic review of consent records and privacy notices
- Assessment of new products against privacy-by-design principles
Establish key compliance metrics and review them monthly. This approach helps you identify and address potential compliance issues before they become serious problems.
Step 15: Enforcement and penalties
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Violating the GDPR can lead to significant fines.
Lower tier fines can reach up to €10 million or 2% of the company’s global annual turnover from the previous financial year.
Higher tier fines can reach up to €20 million or 4% of the company’s global annual turnover from the previous financial year.
To get ready for possible enforcement actions, take the following steps:
- Document all compliance efforts
- Create a response plan for regulatory inquiries
- Budget for ongoing compliance resources
- Stay informed
Monitor decisions from European data protection authorities for insights on regulatory priorities and GDPR interpretation.
Build relationships with privacy professionals in your industry to stay current on emerging compliance challenges.
Consider joining healthcare technology privacy forums to share best practices and stay informed of regulatory developments.
How Legal Nodes can help healthcare technology companies
When resources are tight, finding the right expertise can be difficult. It is important to consult an attorney for a particular legal understanding tailored to your specific circumstances.
Legal Nodes offers specialized support for healthcare tech companies navigating GDPR compliance challenges.
Our GDPR packages are fully customizable and delivered by certified privacy professionals. These packages are designed specifically for B2B and B2C startups.
Legal Nodes can assist you at various stages of your compliance journey:
- When you need to avoid costly GDPR fines
- If you require someone to manage privacy and data protection
- When launching new healthcare technology products
Read our SpatialChat case study to learn more.
The Virtual DPO service provides ongoing support rather than just one-time documentation. It is crucial since GDPR compliance is a continuous process, not a one-time achievement.
We offer UK GDPR representative services for companies with UK operations to ensure compliance with local regulations and EU requirements.
Training is also available through 2-hour live sessions customized to your healthcare technology needs. Your team can ask questions and receive practical guidance on implementing compliance practices.
For international healthcare tech companies, assistance with EU-US data transfers ensures you can operate globally while maintaining compliance.
Start with a free consultation to identify the most suitable GDPR solution for your healthcare technology company and data handling practices.
Conclusion about GDPR compliance in healthcare
GDPR compliance in healthcare goes beyond following rules. It’s about building patient trust. Careful handling of personal data demonstrates respect for their privacy.
While meeting GDPR requirements may seem challenging, the benefits are significant. By complying, you can dodge hefty fines and improve your reputation for data security.
Technology can support you in this process. Using secure platforms and encryption helps you maintain compliance while delivering innovative healthcare solutions.
Keep in mind that GDPR compliance is an ongoing process. Regular audits and procedure updates will keep you current with changing regulations and technology.
If you need help along the way, you can always contact the Legal Nodes team. We will guide you each step of the way.
FAQs about GDPR compliance in healthcare
What is the GDPR compliance checklist?
A GDPR compliance checklist for healthcare is a structured guide to help you meet data protection requirements.
It typically includes steps like conducting data audits, appointing a Data Protection Officer, and implementing security measures.
Transparency in data collection practices is key to ensure compliance with GDPR. Organizations must communicate how they will use data and obtain consent from individuals before any data is collected.
What are the 7 GDPR requirements?
The seven core GDPR requirements for healthcare organizations include:
- Lawful processing: Having valid reasons to collect data
- Transparency: Clearly explaining how you use health data
- Purpose limitation: Only using data for stated purposes
- Data minimization: Collecting only necessary information
- Accuracy: Keeping patient records up-to-date
- Storage limitation: Not keeping data longer than needed
- Security: Protecting data with appropriate measures
These requirements help ensure your organization is GDPR compliant.
What is required for GDPR compliance?
For GDPR compliance, your healthcare company needs to get consent from patients before processing their data. You must also implement appropriate security measures and breach notification procedures.
It is crucial to understand whether your organization stores or processes personal data on its own behalf or on behalf of others, as this determines your responsibilities under GDPR.
You'll need to appoint a Data Protection Officer if you process large amounts of sensitive health data. Regular privacy impact assessments are important to identify and minimize data protection risks.
What are the compliances under GDPR?
GDPR compliance for healthcare includes:
- Patient Rights: Allow access, deletion, and portability of personal data
- Consent Management: Get clear permission to use data
- Data Security: Implement encryption and access controls
- Breach Reporting: Report incidents with key details
- Documentation: Maintain records of processing activities
Remember that GDPR requirements may apply to US companies if you handle EU patients' data!
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