Hosting of Health Data: Legal Obligations and Best Practices

In a context where the digitalisation of the healthcare sector is accelerating, the question of hosting health data takes on crucial importance. This highly sensitive information benefits from enhanced legal protection that imposes specific constraints on organisations.

Between strict regulation and security challenges, how can you navigate this complex framework to ensure the compliance of your health information systems? An analysis of the obligations and best practices to adopt.

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The specific regulatory framework: enhanced protection

The hosting of health data is subject to a particularly strict regulatory framework, which has undergone significant developments in recent years. At the confluence of the GDPR and specific national regulations, this framework aims to ensure a level of protection suited to the particular sensitivity of this information.

In France, the HDS (Health Data Host) certification system constitutes the cornerstone of this framework. This certification, which replaced the former approval regime in 2018, applies to any operator hosting personal health data, whether medical records, prescription information, medical imaging, or any other data relating to the health status of an identified or identifiable person.

The scope of this certification is broad, as it concerns healthcare establishments as well as self-employed professionals, medical software publishers, telemedicine platforms, and insurance companies and mutual health insurers that process medical data. This certification applies not only to direct hosts but also to providers offering SaaS or PaaS solutions that involve the storage of health data.

HDS certification comprises six fundamental requirements: the security policy, risk analysis, human resources management, asset management, access control and incident management. It is issued by accredited certification bodies and must be renewed regularly, generally every three years.

At the European level, the proposed European regulation on the European Health Data Space (European Health Data Space) will further strengthen this framework by harmonising practices across the continent and facilitating the secure sharing of health data between Member States.

Legal and financial risks: deterrent sanctions

Failure to comply with the legal obligations relating to the hosting of health data exposes organisations to considerable risks, both legal and financial as well as reputational.

From a legal standpoint, the absence of HDS certification for the hosting of health data constitutes an infringement that may be sanctioned by administrative fines imposed by the CNIL of up to 20 million euros or 4% of worldwide turnover in the most serious cases. In addition to these administrative sanctions, criminal proceedings may be brought in the event of negligence resulting in a data breach, with penalties of up to five years' imprisonment and a fine of 300,000 euros for those responsible.

Beyond administrative and criminal sanctions, health data breaches also expose organisations to civil liability claims from the data subjects concerned. Such claims may give rise to potentially significant compensation demands, especially where the number of victims is high.

The reputational dimension should not be overlooked either. In the healthcare sector, trust is a particularly valuable asset, and a data breach can lead to a lasting loss of trust among patients, healthcare professionals and partners. Several high-profile cases of medical data leaks have thus had disastrous consequences for the establishments concerned, with lasting impacts on their business and image.

Finally, security incidents in this field can also lead to significant operational disruptions, as demonstrated by the recent cyberattacks targeting hospitals, with potentially dramatic consequences for continuity of care and patient safety.

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The specific obligations of health data hosts

HDS-certified providers are subject to particularly strict obligations that go well beyond standard security requirements. These obligations are organised around several fundamental areas to ensure the protection of sensitive data.

Security governance constitutes the first pillar of these obligations. The host must implement a formalised security policy, appoint a dedicated information systems security officer (CISO), and carry out regular and documented risk analyses. This governance must also incorporate a robust business continuity plan ensuring the availability of data even in the event of a major incident.

The requirements regarding physical security are particularly rigorous. Datacenters hosting health data must meet strict standards concerning protection against intrusions, fires, floods and other environmental risks. Physical access to servers must be strictly controlled, with badge systems, biometrics and video surveillance.

Logical security requires the encryption of data, both at rest and in transit, with particularly robust key management mechanisms. The segregation of environments, fine-grained access rights management based on the principle of least privilege, and the implementation of advanced intrusion detection solutions are also required.

Traceability constitutes a fundamental requirement, with the obligation to retain access and activity logs enabling a precise reconstruction of who accessed which data, when and for what reason. These logs must be retained for a period defined by the regulations and protected against any alteration.

Human resources management is also given particular attention, with obligations to carry out background checks for personnel with access to sensitive data, enhanced confidentiality undertakings, and regular awareness programmes on health data security.

Unlike a standard hosting agreement, the hosting of health data requires additional guarantees and the use of an HDS-certified provider. This certification guarantees that the host has the appropriate technical and organisational measures in place to protect this sensitive data.

Checklist for choosing a compliant host

Faced with these complex requirements, the choice of a health data host represents a strategic decision that must be based on a methodical assessment. Here are the main criteria to consider when selecting a compliant and reliable provider.

The validity and scope of the HDS certification naturally constitute the first essential point of verification. It is important to check that the certification properly covers all the activities required for your project, and to request the certificates currently in force. Do not hesitate to also consult the official list of certified hosts maintained by the certification body.

The contractual guarantees offered by the host must be carefully examined. The contract must explicitly mention the commitments regarding the protection of health data, the guaranteed service levels (in particular in terms of availability and recovery time), and the remediation mechanisms in the event of a breach. The allocation of responsibilities between the client and the host must be clearly established, particularly with regard to GDPR obligations.

The technical infrastructure must be assessed against criteria such as the location of the datacenters (ideally in France or within the European Union to simplify international transfer issues), the redundancy of critical systems, the backup and disaster recovery mechanisms, as well as the encryption technologies used.

The operational security procedures deserve particular attention. Examine in particular the incident management processes, the arrangements for maintenance and the application of security patches, the frequency of penetration tests and security audits, as well as the vulnerability monitoring mechanisms.

Transparency and communication are essential indicators of a host's maturity. A quality provider must be able to provide regular reports on the service levels achieved, security incidents (even minor ones), and the continuous improvement measures implemented. Some hosts offer client portals enabling these indicators to be monitored in real time.

The provider's sector references in the healthcare field also constitute an important element of assessment. A host experienced in this specific sector will have a better understanding of the business challenges and regulatory constraints specific to the medical field.

How to structure a health data hosting project

The implementation of a health data hosting project requires a structured and methodical approach to ensure compliance and security by design. Several key steps must be followed to successfully carry out this type of project.

The preliminary analysis phase is decisive in precisely identifying the types of data concerned, their level of sensitivity, and the processing envisaged. This mapping makes it possible to clearly determine the scope of the HDS certification required and to identify any data that could be processed in a standard environment, thereby reducing costs. This phase must also include a data protection impact assessment (DPIA), which is mandatory for the processing of health data under the GDPR.

The definition of technical and functional requirements must be particularly rigorous. Beyond purely technical aspects such as storage capacity or bandwidth, the security and compliance requirements must be formalised with precision. This step generally leads to the drafting of a detailed set of specifications that will serve as the basis for consulting potential providers.

The provider selection process must include a phase of in-depth auditing of the candidates, going beyond the simple verification of certifications. Datacenter visits may be organised, client references contacted, and technical tests carried out to validate the providers' claims. This selection must involve various stakeholders within the organisation: IT department, DPO, CISO, medical and legal management for a comprehensive assessment.

Contracting represents a critical step that must not be underestimated. The health data hosting agreement must cover all the regulatory, technical and operational aspects of the service. Particular attention must be paid to the technical annexes detailing the service levels, the operating procedures, and the security measures. The drafting of the processing agreement within the meaning of the GDPR must also be given particular care.

The transition and go-live phase must be carefully planned to ensure the integrity and confidentiality of the data during its migration to the new platform. In-depth security, performance and disaster recovery tests must be carried out before any go-live. This phase must also include the training of internal teams in the new operating and security procedures.

Operational monitoring constitutes the final step, but not the least important. A regular steering committee with the provider must be set up to monitor performance and security indicators, manage developments, and ensure the ongoing compliance of the system in the face of regulatory and technical changes.

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Best practices for optimal security

Beyond strict compliance with regulatory obligations, several best practices make it possible to significantly strengthen the security of hosted health data and to reduce the risk of incidents.

The principle of data minimisation constitutes a fundamental approach which consists of collecting and processing only the data strictly necessary for the intended purpose. This approach, enshrined in the GDPR, takes on particular importance for health data. It may translate into the anonymisation or pseudonymisation of data where precise identification is not necessary, thereby considerably reducing the risks in the event of a breach.

The implementation of a defence-in-depth approach is particularly recommended to protect health data. This strategy consists of deploying several complementary layers of security (firewalls, intrusion detection systems, encryption, access controls, etc.) so that a failure at one level is offset by the protections of the other levels. This redundancy of security mechanisms is essential to counter increasingly sophisticated threats.

Regular security testing constitutes a pillar of the protection strategy. Beyond regulatory obligations, it is recommended to conduct in-depth penetration tests at least once a year, complemented by more frequent vulnerability scans. These tests must be carried out by independent teams, ideally certified, and give rise to documented corrective action plans.

The ongoing training of technical teams and users represents a crucial but often neglected investment. Staff must be regularly made aware of the specific risks associated with health data, security best practices, and the procedures to follow in the event of an incident. This awareness must be adapted to the different profiles and responsibilities within the organisation.

The maintenance of active monitoring of regulatory and technological developments is essential in such a dynamic field. This monitoring must make it possible to anticipate normative changes, identify new threats, and rapidly adapt the protection measures. Membership of communities specialising in health data security can facilitate this monitoring work.

Finally, the development and regular testing of an incident response plan specific to health data is fundamental. This plan must precisely define the containment, analysis, remediation and communication procedures in the event of a breach, taking into account the specific obligations to notify the CNIL and, where applicable, the data subjects concerned.

Legal expertise, an asset in compliance

The hosting of health data represents a challenge at the crossroads of technical, regulatory and organisational requirements. In this complex and evolving context, legal expertise constitutes a strategic asset for navigating serenely between the various obligations and putting in place effective governance.

HDS certification should not be perceived solely as a regulatory constraint but as an opportunity to strengthen the trust of patients and healthcare professionals in the digital services offered. This trust represents valuable capital in a sector undergoing full digital transformation.

Organisations that approach this issue with rigour and method, by surrounding themselves with the appropriate expertise, are not only compliant with the regulations but also benefit from a significant competitive advantage in a rapidly expanding e-health market.

In this process of compliance and security, the role of legal advisers proves decisive in correctly interpreting the regulatory requirements, negotiating balanced contracts with providers, and putting in place appropriate governance of health data.