Qualified electronic sealing of medical documentation – ensuring document and patient data security

Electronic medical documentation (EMD) is a modern solution that has transformed the way medical information is collected, processed, and shared. With its introduction, the challenge of ensuring maximum security for this data has emerged. One of the most effective tools in this regard is the qualified electronic seal.

What is electronic medical documentation and what are its types?

E-medical documentation includes all health-related information recorded in electronic form, allowing for easier management and faster access to patient data. The Act of April 28, 2011, on the Information System in Healthcare defines EMD as electronic documents secured with means that ensure their authenticity and integrity. In practice, this includes documents such as:

• e-prescriptions,
• e-referrals,
• test results,
• patient treatment history,
• hospital discharge summaries,
• vaccination records,

and other documents such as details of provided healthcare services and prescribed treatment methods.

Methods of signing medical documentation

Electronic medical documentation must be properly secured against unauthorized access and modifications. This requirement is stated in Article 2, Point 6 of the Act on the Information System in Healthcare. Various methods of authentication for medical documents exist, including:

• Trusted signature – available through services like ePUAP,
• Personal signature – an authentication method linked to an individual user identifier,
• Qualified electronic signature – the most secure form of signature, available only from certified trust service providers or their authorized partners. Its equivalent for legal entities is the qualified electronic seal,
• Verification of origin and data integrity using the IT system provided by the Social Insurance Institution (ZUS).

Other forms of document authentication are permitted only for internal documentation.

How to implement a qualified electronic signature and seal in a medical facility?

Implementing a qualified electronic signature or seal in a medical facility requires a well-thought-out strategy and appropriate technological infrastructure. Choosing the right solution provider is crucial, but the investment is worthwhile, as it streamlines administrative processes, enhances the credibility and integrity of medical documentation, and ensures long-term security of stored records. Additionally, the qualified sealing of electronic medical documentation enables secure document exchange with external entities.

SIGNIUS offers comprehensive solutions that facilitate the easy and secure implementation of remote signing and sealing of documents, including qualified electronic signatures and qualified digital seals. Our services are tailored to the specific needs of medical institutions, ensuring not only compliance with current regulations but also the highest level of protection for electronic medical records.

Both the electronic seal and our electronic signature solutions, such as the digital signing platform, are available in three deployment models:

• Cloud-based (SaaS),
• Hybrid,
• On-premise installation.

We provide seamless integration with internal systems and company processes.

Mass sealing of electronic medical documentation

Using the SIGNIUS Seal qualified electronic seal enables mass sealing of documents, processing up to 30 million documents per hour, leading to significant time and resource savings.

This solution has been successfully implemented at AOK, Germany’s largest health insurance company, allowing it to efficiently manage documents for over 27 million policyholders.

Our solution utilizes a hardware security module (HSM), replacing physical cards and card readers. The module, certified as a Qualified Signature Creation Device (QSCD) in accordance with the eIDAS regulation, can be operated within the company’s own data center.

Conclusion

The security of electronic medical documentation is a critical component of modern healthcare. Thanks to qualified electronic sealing technology, it is possible to significantly enhance patient data security standards and streamline administrative processes.

SIGNIUS is a trusted and experienced partner for companies seeking digital document management solutions. By offering services such as qualified electronic seals and signatures, identity verification, and timestamps, we support medical institutions in the effective management and protection of their electronic medical records.