Health data: definition, regulations, and challenges for organizations

Introduction

In the digital and e-health era, health data has become a major strategic asset. Digital medical records, health tracking apps, connected devices, and telemedicine platforms such as Doctolib generate a colossal amount of personal and sensitive information every day. This data not only makes it possible to monitor individuals' health and patient care, but also to develop medical innovations, improve the quality of healthcare services, and optimize public health services.

However, processing this data involves high risks, such as data leaks or exposure on the dark web, and can have serious consequences for the individuals concerned. Poor management can lead to the disclosure of phone numbers, email addresses, or other personal information, revealing sensitive data related to health status.

For this reason, health data is subject to strict regulations, combining the GDPR at the European level and a set of more restrictive French standards, derived in particular from the Public Health Code, the reference methodologies (MR) of the CNIL (National Commission for Information Technology and Civil Liberties), and the Health Data Hosting (HDS) certification.

What is health data?

Definition

Health data refers to any information relating to a person's past, present, or future physical or mental health. According to the GDPR, this is sensitivepersonal data that benefits from enhanced protection.

This broad definition of data includes not only traditional medical information, such as diagnoses and treatments, but also data from digital technologies, such as connected devices, wellness tracking apps, and databases from clinical research.

Examples of health data:

• Medical records and consultation reports: information on medical history, diagnoses, and treatments.
• Medical examination results: biological analyses, X-rays, medical imaging, disease risk, etc., including the nature of the examinations and associated references.
• Prescriptions and drug treatments: prescriptions, monitoring of chronic treatments on the affected part of the body, etc.
• Data from connected devices: heart rate, physical activity, sleep, blood pressure.
• etc.

Why is health data sensitive?

Health data is classified as sensitive data under the GDPR French regulations, as it reveals intimate information about an individual's life. Its disclosure or misuse can have significant consequences, both personally and socially, given the sensitivity of the data.

Risks associated with poor management

1. Breach of privacy rights : leakage of sensitive personal information.
2. Discrimination: denial of insurance, discrimination in hiring, social stigmatization.
3. Identity theft and fraud: medical data can be used to create fake records.
4. Loss of trust: patients and users lose confidence in healthcare services or medical applications.
5. Ethical and social issues: the commercial use of data for purposes other than medical care is strictly regulated.

That is why securing health data is not only a legal obligation, but also an ethical and strategic imperative for any organization.

Health data: a strengthened regulatory framework in France

While the GDPR the European foundation, it is not sufficient on its own to protect health data. In France, this data is governed by a dense and strict legal framework, which imposes additional and specific requirements.

The GDPR a basic framework

The GDPR health data as special categories of data. Article 9 prohibits their processing except in strictly defined exceptions:

• explicit consent of the Data subject
• legal obligations;
• protection of vital interests;
• public interest in public health;
• preventive medicine, medical diagnosis, or care.

These rules establish a minimum level of protection at the European level, particularly in terms of security, transparency, and individual rights.

The Public Health Code: specific guidelines

In France, the Public Health Code supplements the GDPR requiring:

• enhanced security and confidentiality obligations;
• strict rules for the collection and use of medical data;
• respect for medical confidentiality, protected by law;
• specific requirements for healthcare facilities and professionals.

Therefore, an organization processing health data in France must apply a higher level of protection than that provided for by the GDPR.

The role of the CNIL (National Commission for Information Technology and Civil Liberties) reference methodologies (MR)

The CNIL (National Commission for Information Technology and Civil Liberties) strictly regulates the processing of health data. It proposes reference methodologies (MR) for certain specific types of processing:

• clinical and epidemiological research;
• medical devices and health applications;
• statistical studies and performance evaluations.

Compliance with a MR allows you to comply with the legal framework without prior authorization, provided that all requirements are met. Outside of these MRs, processing requires specific authorization from the CNIL (National Commission for Information Technology and Civil Liberties).

Health data hosting (HDS)

Health data must be hosted by HDS-certified providers, guaranteeing physical and logical security, traceability, backup, and encryption.

The HDS obligation applies in particular to medical software publishers, telemedicine platforms, IT providers speaker health data, etc.

The EHDS: towards a future European framework for health data

Beyond French regulations and the GDPR, the European Union is establishing the European Health Data Space (EHDS), a secure European space for the exchange and use of health data. The aim is to facilitate patient care, medical research, anddata interoperability while ensuring confidentiality and security.

To understand how the EHDS impacts health data processing and organizational obligations, you can review our latest webinar dedicated to the EHDS, where our experts detail the regulatory and practical issues involved.

Who can process personal health data? Only healthcare professionals?

Treatment is not reserved solely for healthcare professionals. The following are also involved:

• Healthcare professionals and institutions: doctors, hospitals, laboratories;
• Insurers and social security organizations: under strict legal conditions;
• E-health companies: monitoring applications, connected devices, telemedicine platforms;
• processors IT service providers: hosting, maintenance, cloud;
• Researchers and public agencies: epidemiological studies, public health.

Each actor must define their exact role (data controller or processor) and comply with strict health and safety policies.

Health data protection: information and references for implementing best practices

1. Encryption: data at rest and in transit.
2. Authorization management: strictly controlled access.
3. Team awareness: regular training on security and confidentiality.
4. Violation procedures: response plans and prompt notification.
5. Regular audits: security and ISO 27001 compliance.
6. Anonymization and pseudonymization: reducing risks in the event of a leak.
7. Documentation and traceability: logging of processing and access.

Strategic and business challenges

Health data is not only a legal issue, but also a strategic one:

• Legal issues: GDPR penalties GDPR to €20 million or 4% of global turnover;
• Financial issues: costs of non-compliance and security incidents;
• Reputation issues: patient and clients trust clients
• Innovation challenges: e-health, medical AI, personalized medicine;
• Competitive advantages: data management, innovative healthcare services, customer loyalty.

FAQ – Health data

Is health data always personal data?
Yes, as soon as it allows a natural person to be identified directly or indirectly.

Can a non-medical company process health data?
Yes, but only with a valid legal basis and in strict compliance with regulatory obligations.

Does the GDPR apply to anonymized health data GDPR
No, only if the anonymization is irreversible, i.e., if it is not possible to reverse the process and re-identify the Data subject. However, pseudonymized data remains subject to GDPR it is still personal data.

What are the CNIL (National Commission for Information Technology and Civil Liberties) reference methodologies (MR) CNIL (National Commission for Information Technology and Civil Liberties)
These are pre-established frameworks for certain types of health data processing, including certain healthcare services, enabling compliance with regulations without specific authorization.

What is HDS hosting and who must comply with it?
It is mandatory certification for any service provider that stores or processes data for healthcare purposes in France. This applies to hosting providers, healthcare management platforms, and medical software publishers.