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February 26, 2019

DMEA Dossier on Electronic Patient Records

The EPR: A medical data hub

From 2021 onwards everyone insured under a statutory health insurance scheme in Germany should have the right to an electronic patient record. However, electronic files for the healthcare system are no longer a vision of the future, as can be seen at the DMEA 2019: Health insurers, hospitals and the federal states as well as a number of health IT manufacturers are making progress in this area and are either developing suitable solutions or have already made them available. Electronic patient records ensure better, more efficient and safer medical care. However, a number of conditions must be met before the large-scale project ’Patient Records in Germany’ can really be regarded as a success. It is important that the technical requirements are not too complex and that the technology and the content are not randomly defined.

Since the new German government took office in 2018 it has been vigorously promoting digitalisation in many areas of society. In the healthcare sector too numerous initiatives and changes to the law have been introduced in the space of just one year with the aim of ensuring that health-related communication in Germany keeps pace with the latest developments. The EU Commission’s European-wide ‘Digital Economy and Society Index’ (DESI 2018) in the summer of 2018 shows how urgent the need is for such initiatives. The overall view held by all industries and social sectors reveals that Germany occupies the middle ground, being placed 14th out of 28 EU member states. When it comes to electronic healthcare services Germany lags far behind, in 26th place out of 28.

Germany aims to make up lost ground

Electronic patient records are among the most important electronic health services. Via the internet or mobile apps they give the insured / patients access to all kinds of health-related data, and permit secure, data-based electronic communication between the patient / the insured on the one hand and medical facilities or other healthcare facilities on the other. But this does not simply mean that they are a depository for digital documents. In fact they make the patients’ own data available to them, which can then be passed on to doctors. They also facilitate administrative communication with the relevant insurer and make important data sets such as vaccination certificates, emergency data or medication plans available.

In Europe the actual form that this can take can be seen in almost all of the Scandinavian countries and in Austria. An electronic health record, ELGA, has been created for all nine million Austrians. Only 3% of them rejected it and have deregistered. An increasing number of hospitals and doctors are able to file clinical findings, medical certificates and medication lists in the ELGA. By 2021 an electronic vaccination certificate will also be introduced. Germany now intends to make up lost ground. People insured with private health insurers such as Allianz and Axa can already make use of electronic health records. From 2021 everyone insured with a statutory health insurance scheme should also be entitled to an electronic health record under the terms of §291a SGB V. A number of health insurers such as Techniker, DAK and a number of company and guild health insurance schemes can offer electronic records to people insured with them. DMEA 2019 provides an opportunity to look more closely at these records, not only in the industry exhibition but also at a special workshop focusing on health insurers’ records.

For those covered by a statutory insurance scheme the current health records as defined by §68 SGB V will be transferred to patient records in accordance with §291a SGB V by 2021. In terms of security these will set new standards, according to Alexander Beyer, CEO of gematik GmbH, the company operating the telematics infrastructure currently being set up for healthcare in Germany: “Under the terms of § 291a, the deployment of connectors, the use of electronic health cards and certification and licensing, patient records will be protected against many potential attack scenarios.”

Success only comes with open, international standards

At the present time the various different health records do not use a uniform framework either technically or in terms of content. In other words they are not yet interoperable. However, this is due to change so that, for example, those who are insured can take their data with them when changing to another insurance provider. The intention is also that hospitals and general practitioners will be able to communicate with their patients in a simple and effective way by means of a smartphone or internet files. It is only in this way that such records will be able to reveal their benefits in everyday use. As Jens Naumann, Chairman of the German Association of the Healthcare IT Industry – bvitg e.V. points out, it will be necessary to structure the data interfaces of an electronic patient record in a uniform way in order to ensure that interoperability is really achieved. “There is no point in having to re-invent the wheel for each record or in any state or healthcare system.” If it is not possible to achieve internationally uniform standards for electronic patient records, such applications will also become unnecessarily expensive because the outlay for companies that have to adopt an individual, national approach will be much greater.

For this reason the bvitg e.V. published a “Recommendation for the interoperability of interfaces for records” in September 2018, describing the technical requirements that must be met by an electronic patient record in order for it to be interoperable. These specifications refer to subject matter such as the exchange of documents, patient identification, authentication, keeping a written record and transport encoding, consent and authorisation, the document format to be used and the exchange of image data. The bvitg is not acting on its own: At the end of January 2019 the EU Commission published its own recommendations for a European format for exchanging electronic patient records. These correspond in many respects to the recommendations by the industry in Germany, but are not so detailed. Visitors to DMEA 2019 will have plenty of opportunities to learn about standardisation and interoperability in a digital healthcare system. A special congress session will be just one of the aspects devoted to this subject. The bvitg Working Group on Interoperability and Standardisation is also organising a panel session on electronic patient records and interoperability.

AOK Health Network: a record with international standards is a possibility

National patient record projects such as those in Austria and in Switzerland show that electronic patient records can be implemented using international standards as a basis. This is possible in Germany too, as illustrated by the Digital Health Network of AOK Nordost, which has been implemented in line with the bvitg recommendations. “Uniform standards make it easier to interconnect all the service providers. The connection can only function seamlessly as long as the interfaces that are used share a common language”, explains Nico Schwartze, head of digital innovation management at AOK Nordost.

In the AOK’s Digital Healthcare Network the emphasis is on so-called IHE profiles and security protocols for areas such as the exchange of documents, secure authentication and digital management of contracts and rights. IHE profiles are virtually construction manuals for parts of the electronic record, ensuring that different software solutions are mutually understandable. With these profiles it is important that they are implemented exactly as internationally agreed. If the IHE profiles are modified too drastically they will no longer be able to exert their unifying effect.

A great need for adaptation and discussion

This is one of the reasons why the industry believes that there is still substantial room for improvement to the initial version of the technical specifications for the electronic patient record in accordance with §291a that was submitted at the end of 2018. “Although gematik has taken the IHE profiles into account, it has altered them considerably. This will make it very difficult to link up with existing hospital networks and furthermore, IT solutions of internationally proven effectiveness cannot be deployed on the basis of current specifications”, explains bvitg CEO Sebastian Zilch.

If the requirements remain as currently envisaged, this will make the development of electronic patient records much more complicated, protracted and expensive than need be, according to Zilch. Furthermore the potential offered by digitalisation would not be enhanced because until now provision has only been made for storing PDF documents, but not structured data sets: “This makes it more difficult to develop useful applications. Overall there is still an extensive need for adaptation and discussion.”

Many stakeholders in the healthcare sector believe that there is also a need for discussions about who should make decisions about the medical data objects to be incorporated in the electronic patient record in future. This question is likely to be the subject of the digitalisation law (eHealth Law 2.0) that has been announced by the Federal Ministry of Health, the first draft of which is expected this summer. At present it would seem that politicians intend to place responsibility for this matter in the hands of the KBV, the organisation representing medical practices belonging to the German health insurance system. However, this has encountered widespread criticism from, among others, the German Hospitals Society (DKG), as well as from many specialist medical associations and standardisation organisations.

USA: Whoever stashes data away risks sanctions

Some interesting impulses are currently coming from the United States of America. Unlike in Germany, the US Office of the National Coordinator for Health Information Technology (ONC) is a body that lays down the rules for the digitalisation of the healthcare sector, and can also demand technical and semantic standards, The leverage for this comes from an extensive national programme for funding healthcare IT, which had its origins in the Obama administration.

At the beginning of February the ONC announced that new specifications are to be introduced to discourage so-called information blocking. The aim of these intended regulations is to impose sanctions on medical facilities and providers of healthcare IT and to list them publically if they do not enable patients to easily obtain their data in the form of digital data sets and place such data in electronic patient records. In so doing the authority specified actual technical standards that must be adhered to. The focus for the ONC is HL7, including the latest HL7 standard HL7 FHIR, which also occupies an important place in the bvitg recommendations on the interoperability of report interfaces. This is becoming increasingly widespread. A number of sessions and guided tours on this aspect will also be taking place at DMEA 2019.

Outline details of timing of events

Day 1 at DMEA (9 April 2019):

 Workshop: Health Insurers’ Solutions for Records (time: 9.30 a.m. – 1 p.m., venue: _Lovelace Room, Hall 1.2)

 Guided tour of the fair: Electronic Patient Record (time: 2.30 - 3.30 p.m.| venue: Centre Foyer, Hall 3.2 | 4.2)

 eHealth Hot Seat (time: 3.45 – 4.45 p.m.| venue: _Box, Hall 1.2)

 Guided tour of the fair: FHIR (time: 3.45 – 4.45 p.m.| venue: Centre Foyer, Hall 3.2 | 4.2)

 Talk: eHealth strategy: The European Perspective (time: 5 - 6 p.m.| venue: _Hub 4, Hall 4.2)

 Talk: TI Financing is in Place for Hospitals: What now? (Time: 5 - 6 p.m.| venue: _Hub 1, Hall 2.2)

Day 2 at DMEA (10 April 2019):

 Guided tour of the fair: FHIR (time: 11.30 a.m. - 12.30 p.m.| venue: Centre Foyer, Hall 3.2 | 4.2)

 Workshop: Introduction to HL7 FHIR® (time: 1.15 – 2.45 p.m.| venue: _Lovelace Room, Hall 1.2)

 Panel: VSDM, NFDM, eMedication Plan…what’s next? Applications from the Telematics Infrastructure (time: 1.15 – 2.15 p.m.| venue: _Hub 4, Hall 4.2)

 Panel: 1 Year of eHealth in the Grand Coalition: Interim Summary of Health Policy (time: 2.30 - 3.30 p.m.| venue: _Stage B, Hall 2.2)

 Panel: All your data belongs to us: EPR from the Data Protection Perspective (time: 2.30 - 3.30 p.m.| venue: _Hub 2, Hall 2.2)

 Talk: The Electronic Case File – Physician-led Data Exchange in the File Jungle (time: 3.45 – 4.45 p.m.| venue: _Hub 2, Hall 2.2)

Day 3 at DMEA (11 April 2019):

 Congress session: EPR – Benefits for Physicians or Benefits for Patients? (Time: 9.30 a.m. – 11 a.m. | venue: _Stage A, Hall 1.2)

 Workshop: 50 Years of the Electronic Patient Record (time: 1.15 – 2.15 p.m.| venue: _Box, Hall 1.2)

 Guided tour of the fair: Electronic Patient Record (time: 1.15 – 2.15 p.m.| venue: Centre Foyer, Hall 3.2 | 4.2) Panel: Electronic patient file – Confusion or is Everything Interoperable? (Time: 2.30 - 3.30 p.m.| venue: _Hub 4, Hall 4.2)

About DMEA

DMEA is the successor to conhIT – Connecting Healthcare IT, and represents a strategic evolution of that concept. It aims to mirror the entire digital supply chain including every process along the way. Step by step DMEA will expand into a platform representing every digital field of interest to all players in the healthcare system, both now and in the future.

DMEA targets decision-makers in every healthcare sector – hospital managers, IT heads, doctors, nurses, healthcare policymakers and experts in science and research. As an integrated event combining a trade fair, congress, academy and a wide range of interactive formats, it gives participants the opportunity to find out about the latest digital healthcare developments and products, establish industry contacts and acquire high-level qualifications. DMEA is held by the German Association of Healthcare IT Vendors (bvitg) and organised by Messe Berlin. DMEA is organised in cooperation with the following industry associations: the German Association of Healthcare IT Vendors (bvitg), the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), the German Medical Informatics Professional Association (BVMI). The National Association of Hospital IT Managers (KH-IT) and the Chief Information Officers of University Hospitals (CIO-UK) provide contributions on the subject matter. The three-day event takes place annually on the Berlin Exhibition Grounds.

More information on products, topics, events and industry trends can be found by visiting the health IT homepage of bvitg Service GmbH, a subsidiary of the German Association of Healthcare IT Vendors (bvitg).