Key points to note regarding the protection of medical data:
- Medical data constitutes special category data within the meaning of the GDPR: its processing requires enhanced safeguards and the ability to demonstrate compliance.
- Protection rests on an inseparable triptych: confidentiality (strictly authorised access, authentication, encryption), integrity (detection of any alteration) and availability (continuity of care).
- Traceability (who created, accessed, validated or signed a document, and when) is decisive in the event of an audit, inspection or dispute, through reliable and certifiable logging mechanisms.
- The evidential value of digital health documents requires proof of existence at a reliable date, absence of modification and verification of the professional’s identity, by means of electronic signatures, electronic sealing and electronic timestamping.
- The involvement of a trust service provider within the meaning of eIDAS complements HDS-certified hosting and cybersecurity measures by securing the evidential layer (presumption of reliability, legal recognition) and the long-term preservation of proof.
Medical data and the applicable regulatory framework
Health data encompasses all information relating to the physical or mental health of an individual. This includes patient records, medical reports, test results, prescriptions, certificates and data generated by connected medical devices.
Under the General Data Protection Regulation (GDPR), such data is classified as special category data. Its processing is strictly regulated and permitted only in specific circumstances, such as the provision of medical care or compliance with defined legal obligations. Controllers must be able to guarantee the confidentiality, integrity and availability of data, and must also be able to demonstrate compliance. This enhanced protection is intended to safeguard patients’ privacy, dignity and fundamental rights.
In the United Kingdom, the confidentiality of medical data is governed by the Common Law Duty of Confidentiality, the Data Protection Act 2018 and the UK GDPR, which classify health data as “special category data” subject to an enhanced protection regime. The retention of records is governed by the NHS Records Management Code of Practice.
In relation to hosting, providers must demonstrate compliance with the Data Security and Protection Toolkit, the NHS cybersecurity standards and, in most cases, international standards such as ISO/IEC 27001, ensuring a high level of technical and organisational security.
Furthermore, where a medical document must be signed or produce legal effects, the eIDAS Regulation governs trust services, including electronic signatures and electronic timestamping. Recourse to a qualified trust service provider strengthens the evidential value of documents and their legal recognition.
Confidentiality, integrity and availability: the three requirements for protecting medical data
The protection of medical data rests on a balance between three fundamental principles.
Confidentiality: protecting access to sensitive information
Confidentiality ensures that only authorised persons may access medical data. It is based on strict access controls, strong user authentication, encryption of data and rigorous management of authorisations.
Within a healthcare institution, this means that each professional may access only the information necessary for the performance of their duties. This limitation is indispensable to safeguarding patients’ privacy and complying with medical confidentiality obligations.
Integrity: ensuring the reliability of documents
Integrity ensures that a medical document cannot be altered without such alteration being detectable. A prescription, examination report or certificate must remain consistent with its original version. An unrecorded modification may expose a professional to liability or undermine the quality of care.
Integrity relies on technical mechanisms such as electronic signatures, electronic seals and qualified electronic timestamps. These mechanisms make it possible to demonstrate that a document has remained unchanged since its creation or validation.
Availability: ensuring continuity of care
Availability ensures that data can be accessed whenever required for patient care. An interruption in access to a medical record may compromise diagnosis or treatment. It requires resilient infrastructures, regular backups and business continuity arrangements adapted to healthcare environments.
These three dimensions are inseparable. Data that is confidential but unavailable undermines the quality of care. Data that is available but altered loses all reliability. The balance between these requirements forms the foundation of medical data protection.
The importance of traceability
In a digitised healthcare environment, it is necessary to know who created a document, who consulted it, who signed it and when. Traceability constitutes a central component of security and compliance.
In the event of inspection, audit or dispute, the ability to demonstrate the complete history of a document may prove decisive. It enhances transparency and contributes to accountability. This requires reliable logging mechanisms combined with certification processes guaranteeing the authenticity of recorded events.
The evidential value of digital health documents
A medical document may produce significant legal effects: justification of sick leave, proof of a medical act, or decisive evidence in litigation. In a dematerialised environment, the issue becomes one of evidential value. It must be possible to demonstrate that a document existed at a specific date, that it has not been altered and that it originates from the identified professional.
In the absence of appropriate evidential mechanisms, these elements may be challenged. The establishment of a digital chain of trust secures these guarantees and strengthens the legal recognition of documents.
The role of a trust service provider
The requirements described above — confidentiality, integrity, availability, traceability and evidential value — cannot rest solely on internal policies or secure hosting infrastructures. They require certified technical mechanisms, legally recognised and interoperable at European level.
This is precisely the function of a trust service provider within the meaning of the eIDAS Regulation.
A qualified provider operates at the evidential and authenticity layer of digital documents. It complements HDS hosting arrangements and cybersecurity measures by securing the identity, integrity and reliable date of documents produced in the course of medical processes.
Ensuring integrity and traceability
Ensuring the integrity of medical documents requires the ability to demonstrate that no alteration has occurred after validation. Traceability requires clear identification of who created, validated or signed a document, and at what time.
Through electronic sealing and qualified electronic timestamping, each document may be associated with a unique cryptographic fingerprint and a reliable date. Any subsequent alteration becomes detectable.
A qualified electronic signature makes it possible to associate a verified identity with a medical or administrative act. Each validation, signature and issuance of a document can therefore be reliably traced.
These mechanisms simultaneously strengthen document integrity and the traceability of actions.
Strengthening evidential value
Evidential value depends on the ability to produce a document before a court or authority and to demonstrate its authenticity.
Qualified services governed by eIDAS benefit from a presumption of reliability throughout the European Union. A document signed or timestamped by a qualified provider is legally recognised, unless proven otherwise.
In the medical field, such recognition is decisive in the event of litigation, administrative inspection or dispute. It transforms a simple digital file into enforceable documentary evidence.
Contributing to confidentiality and availability
While confidentiality and availability primarily depend on infrastructure and internal organisation, trust services contribute indirectly to these objectives.
Certification of signatories’ identities limits the risk of impersonation. Electronic sealing protects against unauthorised modification. Timestamping preserves verifiable proof, even in the event of system migration or technological evolution.
By ensuring that documents remain authentic and usable over time, these mechanisms support continuity of care and the reliability of administrative processes.
By combining qualified electronic signatures, electronic seals and certified timestamping, a trust service provider such as Evidency offers a structured response to the challenges identified above.
It does not replace hosting or cybersecurity arrangements, but complements the protection architecture by securing the evidential layer of medical documents. This alignment enables the construction of a coherent digital chain of trust, both technical and legal.
Securing medical documents over time
Protecting medical data does not consist solely in preventing unauthorised access at a given moment. It also requires ensuring that documents remain reliable, authentic and legally enforceable several years after their creation.
In an evolving technological environment, the ability to preserve verifiable proof over time becomes indispensable. By structuring a digital chain of trust incorporating qualified signatures, seals and timestamps, organisations reduce legal exposure, facilitate audits and strengthen the confidence of patients, partners and authorities.
It is within this framework that qualified providers such as Evidency operate, securing the evidential layer of medical documents and enabling these guarantees to be embedded directly at the core of digital processes.
Conclusion
The protection of medical data does not end with preventing unauthorised access. It depends on a demanding balance between confidentiality, integrity, availability and evidential value.
In a healthcare environment that is now largely digitised, institutions and professionals must adopt a comprehensive approach combining technical security with legal safeguards.
The GDPR, the Public Health Code, HDS certification and the eIDAS Regulation form the pillars of this framework. Their articulation makes it possible to construct a genuine digital chain of trust.
If you wish to secure your medical documents or strengthen the evidential value of your digital processes, the Evidency teams can assist you in implementing a compliant solution tailored to your regulatory requirements.
