This raises a number of questions. How can data integrity and security be guaranteed throughout the entire document lifecycle? What are the risks of fragmented management? And how can a unified approach to the information processing chain provide additional guarantees, in terms of both security and compliance?

Jean-Marc Rietsch, an expert in archiving and document digitalisation, and founder and president of our Pineappli solution, shares his insights in this article.

Managing health data: between digital transformation and regulatory requirements

The digital transformation of the healthcare sector is driving an explosion in health data, fuelled by electronic medical records (EMRs), mobile monitoring applications and information-exchange platforms. Test results, prescriptions and medical imaging generate continuous, diverse and often highly sensitive information flows.

As this digitalisation accelerates, the links between the various stakeholders involved become closer. As Jean-Marc Rietsch explains: “Healthcare professionals, hospitals and service providers now share data via interconnected systems. While these systems simplify the exchange of information, they also make managing and securing this information more complex, at every stage of its lifecycle.”

To govern the sector’s digitalisation, the management of patient data is subject to a strict regulatory framework designed to ensure its confidentiality, integrity and security.

At the European level, the General Data Protection Regulation (GDPR) sets out principles such as data minimisation, informed consent and transparency regarding data use.

In France, the French Data Protection Act and Public Health Code supplement this framework. More specifically, Article L.1111-8 of the Public Health Code governs the hosting of health data, requiring such data to be stored exclusively by providers holding the Health Data Hosting (HDS) certification. This certification ensures compliance with technical and organisational requirements intended to provide a high level of protection against risks of loss, theft or unauthorised disclosure of medical data.

The medical data processing chain: a complex environment

Managing medical data goes beyond simply recording information. It follows a structured path involving multiple steps, stakeholders and technologies.

Take, for example, a company that designs medical devices such as prostheses. The process begins with patient data being collected by practitioners located both in France and abroad. This information – medical examinations, images and precise measurements – is captured using specialised software.

Associated documents (laboratory results, prescriptions, reports, etc.) may also be electronically signed by the relevant parties. In particular, using a qualified electronic signature as defined by the European eIDAS Regulation is preferred, because it benefits from the presumption of reliability.

Once collected, the data must be securely transferred to the prosthesis manufacturing sites. There, it is used to design and customise medical devices to meet each patient’s specific needs. Lastly, once the prostheses have been manufactured, all the data is archived to ensure its long-term preservation.

However, as Jean-Marc Rietsch points out: “Each stage involves different stakeholders – doctors, administrators, medical staff – and relies on systems that are sometimes heterogeneous. But every time there is a transition, especially when transferring data from one information system to another, risks arise that could expose sensitive data to breaches.”

Fragmented management of medical data: what are the security risks?

These issues mainly stem from a fragmented approach to the data processing chain, where each stage is handled in isolation. When this chain is not designed as a coherent whole, organisations are exposed to several risks:

  1. Data breaches: When healthcare organisations rely on multiple software tools or platforms to exchange data, the number of potential entry points for attacks increases. Without adequate security, these exchanges may allow malicious individuals to illegally access sensitive patient information.
  2. Human error: In medical settings that use many different tools and where automation is often lacking, much of the workload falls on human operators. Manual data entry, configuration errors and the incorrect use of interfaces increase the likelihood of mistakes. These risks are often exacerbated by inadequate training, high-pressure work environments or poorly defined responsibilities. These mistakes can have serious consequences, both for the quality of care and for the security of information systems.
  3. Loss of traceability: The lack of a unified and coordinated system makes it difficult to track data throughout its lifecycle. When issues arise, correctly auditing the data trail becomes complex, which can cause difficulties during regulatory compliance checks or analyses.
  4. Invalid electronic signatures: An improperly implemented approach to electronic signatures may render them legally invalid. As Jean-Marc Rietsch explains: “An electronic signature is used to prove the signatory’s consent. If the process to authenticate the signatory is not sufficiently secure, or if the signature system cannot guarantee that the document was approved by the correct person, the electronic signature loses all its value.”
     

Pineappli: an integrated solution for document security in healthcare

LuxTrust’s Pineappli solution provides a comprehensive suite of tools specifically designed to securely manage medical data throughout its entire lifecycle.

It includes key features such as qualified electronic signatures, certified and secure electronic archiving with probative value, controlled document sharing, secure data transfer and granular access rights management. With Pineappli, healthcare organisations can protect sensitive data, ensure its integrity and traceability, and simplify day-to-day data management.

A solution designed for compliance

The Pineappli solution is ISO 27001 and HDS (Health Data Hosting) certified, making it well suited to the healthcare sector.

As an eIDAS-certified trust services provider, Pineappli meets European requirements for electronic signatures and electronic archiving. It is also NF461 certified, France’s premier archiving standard, and qualified in the Principality of Monaco for data archiving.

Secure your health data with a unified approach

As Jean-Marc Rietsch points out: “The aim is really to give every stakeholder a holistic view, enabling them to orchestrate all data flows, from creation to archiving, without any loss of control or  traceability.”

LuxTrust’s Pineappli addresses this challenge by centralising how data is preserved, electronically signed and accessed, while guaranteeing data integrity, traceability and legal compliance. Each confidential document is secured from the moment it is created until it is ultimately archived.

Are you interested in finding out how this integrated approach can be tailored to your healthcare organisation?

Contact our experts for a personalised demonstration and a detailed assessment of your needs.