Article 32 of GDPR requires those who control and process personal data to put in place suitable technical and organizational steps to keep data safe while it is being used. Healthcare providers must make sure patient data is kept confidential, accurate, and available. They need to restore access to data quickly after problems like hardware failure, hacking, or accidental deletion.
Even though GDPR is a European law, it applies outside Europe when U.S. healthcare groups provide services to European patients or work with international partners. This means U.S. medical practices must align their data security and disaster recovery plans to:
If data is not made available quickly, it can cause fines, business disruptions, harm to reputation, and poor patient care.
Data availability is one of three key parts of information security, called the CIA Triad: Confidentiality, Integrity, and Availability. Confidentiality keeps patient data private. Integrity makes sure the data is correct. Availability means authorized people can access the data when they need it.
In healthcare, having access to data at the right time is very important. Doctors use patient information to diagnose, treat, and handle emergencies.
When healthcare systems go down, it costs a lot of money and can harm patients. Studies show downtime in healthcare can cost over $1.1 million each hour. This is why strong backup and recovery plans that meet GDPR rules are needed.
Healthcare is a common target for cybercriminals, especially ransom attacks. These attacks lock data by encrypting it and demand money to unlock it. Attacks like these have grown by 500% globally in the last year. Healthcare is targeted because its data is very important.
These attacks block access to patient records, slow down treatment, and can put lives at risk. Healthcare groups need to be ready to restore data fast and safely. Doing this helps avoid long downtimes and meet GDPR and HIPAA laws.
Good data management, including backups and disaster recovery, is key to making sure data is available. Healthcare organizations should keep several backup copies in different physical locations. This protects data from disasters or cyberattacks. The 3-2-1 backup rule is advised: keep three copies of data, on two different storage types, with one copy off-site.
Immutable backups are copies that cannot be changed or deleted by anyone not allowed. These backups are very important in ransomware cases, where attackers try to destroy backups to force payment. Using immutable backups with strong access controls like multi-factor authentication (MFA) and role-based access control (RBAC) helps protect backup data.
It is important to regularly test backup and recovery steps. This makes sure backups are complete, correct, and can be restored quickly. Manual backup processes can be slow and prone to mistakes. Automated backup solutions help by regularly checking backups and running disaster recovery tests.
Cloud-based healthcare apps spread data over many places. This can make security and recovery hard. Under the Shared Responsibility Model, cloud providers secure the infrastructure, but customers must protect the data itself. IT managers in healthcare must make sure cloud data is backed up properly, considering how long data is kept and risks of accidental deletion.
U.S. healthcare providers must follow HIPAA, which requires data backup plans and disaster recovery to protect electronic protected health information (ePHI). GDPR adds more rules on protecting personal data and making sure data is restored quickly.
Many healthcare services also work toward SOC 2 compliance. SOC 2 is a set of standards made by the American Institute of Certified Public Accountants (AICPA). It covers rules on security, availability, data accuracy, confidentiality, and privacy. SOC 2 audits check if technical and organizational steps meet GDPR and HIPAA rules. This gives patients and partners confidence their data will stay safe and accessible after incidents.
Healthcare organizations should think about SOC 2 certification when choosing third-party vendors for data processing, like AI services or communication tools.
When patient data is not restored quickly, healthcare work suffers. Doctors, nurses, and office staff need fast access to patient files, images, and lab results to provide care.
Downtime disrupts scheduling, billing, pharmacies, and emergency work. For example, if data is not available, hospitals may fail to answer data access requests within the 30-day GDPR limit, which increases risks.
Artificial intelligence (AI) is becoming more common in healthcare to make administration easier. Some companies focus on AI-driven phone systems and answering services. These help clinics communicate better with patients while lowering manual work.
AI helps healthcare teams by watching systems for signs of problems like ransomware or unauthorized access. Finding issues early allows for faster responses before data availability is lost.
AI can also automate backup checks and data quality reviews to keep systems ready for quick recovery. For places with limited budgets and IT staff, AI can make it easier to meet GDPR Article 32 rules.
AI-powered front-office tools lower errors in scheduling and data access. They help keep data accurate and available from the office side. AI answering services handle patient questions and appointment requests quickly, keeping operations running even if staff are busy or away.
Combining AI communication tools with electronic health records (EHR) and backups helps reduce data access mistakes. For example, some AI systems quickly send patient data requests to the right staff or systems. This supports meeting GDPR and HIPAA deadlines.
Healthcare data systems are complex and face more cyber threats. This means IT and security teams must work closely together. Backup and availability cover both areas.
Security teams protect data privacy and accuracy, while data teams handle backups, restoration, and keeping business running. Fighting ransomware needs teamwork that includes:
Robert Shields, a data security expert, points out that backup data is a prime target during ransomware attacks. He says having immutable backups, requiring several approvals for backup changes, and close teamwork help cut downtime.
How often data is available affects healthcare costs. Recovering from ransomware can cost about $2.73 million on average. Downtime in healthcare can cost over $1.1 million each hour. These numbers show why investing in data backup and restoration technologies to meet GDPR Article 32 is important.
Stopping long data outages lowers both direct costs for recovery and indirect costs like damage to reputation, unhappy patients, and possible fines.
Healthcare providers who want to follow GDPR Article 32 and HIPAA should:
Following these steps helps healthcare organizations in the U.S. keep working smoothly, protect patient data, and prove they follow GDPR and related laws.
Medical administrators and IT managers should know that keeping patient data safe is not just an IT matter. It is an important part of healthcare that affects patient safety, following the law, and costs. Restoring data quickly after technical or physical problems, using proper tools and procedures, will protect healthcare work in a complex and risky environment.
They must implement appropriate technical and organisational measures ensuring a level of security appropriate to the risk, including pseudonymisation, encryption, confidentiality, integrity, availability, resilience, and regular evaluation of these protections in processing personal data.
It should be assessed by considering the state of the art, implementation costs, the nature, scope, context and purposes of processing, and risks of varying likelihood and severity to the rights and freedoms of natural persons.
Pseudonymisation and encryption of personal data, ensuring ongoing confidentiality, integrity, availability, resilience of processing systems, and the ability to restore data access promptly after incidents.
Regular testing, assessing, and evaluating the effectiveness of technical and organisational measures, and ensuring that personnel only process data according to controller instructions or legal requirements.
It requires the controller and processor to consider risks like accidental or unlawful destruction, loss, alteration, unauthorised disclosure, or access to personal data in their security measures.
They may be used as an element to demonstrate compliance with security requirements, supporting adherence to appropriate technical and organisational measures.
They must not process personal data except on the controller’s instructions, unless required by Union or Member State law.
Because timely restoration after physical or technical incidents ensures continuity and reduces the impact on data subjects and healthcare operations relying on AI agents.
It reduces the risk of identifying individuals in processed data while preserving data utility, enhancing privacy and security in AI-driven healthcare applications.
Regular testing ensures that technical and organisational safeguards remain effective over time against evolving threats and vulnerabilities, crucial to protect sensitive healthcare data handled by AI agents.