The healthcare sector has changed dramatically over the past several years, and one of the main developments is the increased digitization and centralized storage of health data. In this context, the concept of electronic health record is used more and more. But what is behind the concept? What benefits and challenges does it bring with it? In this article, we answer questions and provide an overview of the legal regulations for digital health records in different countries.

Definition: What is an electronic health record?

Electronic health records are digital records that allow patients to collect and manage their health data electronically, and a range of businesses have developed solutions that are available commercially.

Electronic health records vs. electronic patient records

Both concepts describe digital records that contain medical information about patients. For example, hospitals and doctor's practices use these records to collect all of a patient's documents, such as diagnostic results, x-rays, consent letters, discharge papers, and more, in one place. They also archive these records for the long term after treatment has been completed.

However, there are also legally established concepts that refer to something different: the German ePA (electronic patient record) and the Austrian ELGA (electronic health record).

ePA

The ePA is the statutory electronic patient record in Germany, and it is used by medical care providers (e.g. doctors, hospitals, and therapists) to exchange data. Health insurance companies are legally required to provide insured persons with an ePA. Doctors and hospitals have to use the ePA and comply with strict data protection requirements. The ePA contains specific medical information such as results, diagnoses, and therapeutic measures.

In contrast to a classic patient record, the ePA is used not only internally to manage patient information, for example, in a clinic, but it is also used to share information between practices and hospitals. This means doctors can have, for the first time, the whole picture when it comes to patient information.

ELGA

The ELGA, on the other hand, is the statutory electronic patient record in Austria. The record was introduced with the same goal of standardizing the sharing of information between doctors and providing the complete picture of the patient. Patients have access to the data in their ELGA at any time and can view it on a portal.

Similar to the ePA for Germany and the ELGA for Austria, there are also statutory electronic health records in many other countries that make it easier for doctors to work with each other and collect patient data.

Country-specific legal regulations for health data

Specific laws and regulations apply to the handling of health data in different countries. Here is a detailed overview:

United States

• Is a health record required by law? In the US, there is no universal, statutory healthcare system as found in many other countries. The American healthcare system is a mix of some government and a variety of private providers and programs. The electronic health record (EHR) in the US is a system that digitally stores the medical data of patients.
• What law applies? The Health Insurance Portability and Accountability Act (HIPAA). This law went into effect in 1996 and it governs protection of health data. The law requires companies that work with such protected data to implement and comply with certain physical, network, and process-specific security measures. In concrete terms, this means that anyone in healthcare who provides treatments that involve US patient data is subject to HIPAA compliance rules.

United Kingdom

• Is a health record required by law? In the UK, one organization – the National Health Service (NHS) – is responsible for managing all patient information. The NHS is funded by taxes and national social insurance contributions. There is no individual legal right to a national health insurance.
• What is the legal basis for managing patient information? Following Brexit, the United Kingdom introduced the United Kingdom General Data Protection Regulation (GDPR) and the Data Protection Act 2018. The GDPR is the law governing the storage of personal information, which includes health information.

Germany

• Is a health record required by law? Yes, the electronic patient record (ePA).
• What law applies? The Patient Data Protection Act (PDSG), which went into effect in October 2020. Since 2021, health insurance companies have had to offer their insured persons an electronic patient record. Patients have the right to have their doctor enter data into the ePA. With the electronic patient record, the patient alone decides what happens to their data. Insured persons therefore determine which data are stored in the ePA and which are deleted. They also decide on a case-by-case basis who is allowed to access the ePA.

Austria

• Is a health record required by law? Yes, the Austrian electronic health record (ELGA).
• What law applies? The Electronic Health Records Act (ELGA Act), which went into effect in January 2013. It specifies how to define ELGA health data and how to standardize ELGA results. It also regulates who is responsible for implementing which ELGA components.

Switzerland

• Does the law require a health record? Yes, in Switzerland there is a legal regulation for an electronic health record, and it is known as the electronic patient record (EPR).
• What law applies? The Federal Act on Electronic Patient Records (EPDG). It has been in force since 2017. The law sets forth the general requirements for the EPDG. It describes how to strengthen the quality of medical treatment, improve treatment processes, increase patient safety, boost the efficiency of the healthcare system, and promote health literacy in patients.

Spain

• Is a health record required by law? Spain has a type of patient record required by law, the Historia Clínica Electrónica (HCE). It contains all the clinically-relevant data about the healthcare services provided to a patient. Each autonomous community in Spain works to implement the HCE, while the central government ensures interoperability through the Sanidad en Línea program.
• What law applies? Law 41/2002, of November 14, basic regulation on the autonomy of the patient. It regulates patients’ autonomy and their rights and obligations regarding information and clinical documentation; it came into effect in 2003. The law creates a legal framework for ensuring that patients are informed, clinical documentation is provided, and the patient’s wishes are respected in the field of medical care.

France

• Is a health record required by law? Yes, in France there is a legal regulation for an electronic patient record known as the Dossier Médical Partagé (DMP). It was introduced as a pilot project with the health insurance reform law in August 2004. After a lengthy testing phase, the DMP was implemented across the board for the first time in 2011. After some teething problems and a four-year stagnation phase, DMP operations were resumed in 2016. The DMP has been in use across the board since November 2018.
• What law applies? The law relevant for the Dossier Médical Partagé (DMP) in France is Law No. 2004-810, introduced in 2004 by the French Ministry of Health. The aim of this law is to provide every French person with a digital record that they can access anytime, anywhere, and that contains all the patient's medical data.

Hey Doxi, what are the benefits and challenges of electronic health records?

Compliance with digital patient records for clinics

As you can see, there are strict legal requirements for digital health records. To ensure that they comply fully with regulations for digital patient records specialized software is required.

That’s where Doxis comes into play. As a powerful enterprise content management (ECM) system, it provides businesses and organizations in healthcare a comprehensive solution for managing and archiving all of a patient's relevant documents, whether in a clinic, throughout a network of clinics, or across organizations. All documents are managed strictly in accordance with data protection guidelines and are only accessible by authorized persons.

Digital patient records with Doxis: benefits at a glance

1. Access all relevant information: Whether previous illnesses, diagnoses, diagnostic reports, or treatment information – in Doxis you can find all the relevant information for patients (in your hospital or clinic network), from endoscopy images to laboratory reports and emails.
2. Integrate Doxis seamlessly in your hospital information system (HIS): All the information from the HIS, as well as resulting documents, such as bills or medication plans, are stored and managed in the digital patient record in Doxis. Relevant information can be transferred to statutory health records, such as the ePA, via interfaces.
3. Mobile access to patient records: Making hospital rounds? Quickly access patient records from anywhere, also in case of emergencies.
4. Route and distribute documents efficiently: With automated workflows, you can route documents between different departments and clinics quickly and consistently.
5. Audit-proof archiving: With Doxis you can archive all patient information in compliance with laws and protect it from unauthorized access.

Doxis provides you with a comprehensive solution for managing and archiving your patient information in digital records in a clear, legally-compliant, and access-restricted manner.