The Law on Digital Modernisation of Healthcare and Nursing has been in force since 9 June 2021. Its German title is “Digitale-Versorgung-und-Pflege-Modernisierungs-Gesetz”, abbreviated to DVPMG. This law amends numerous other laws and regulations, for example Volume V of the Social Insurance Code and the Regulation on Digital Health Applications. The DVPMG goes well beyond the introduction of digital health applications.
Most stakeholders affected by the DVPMG welcome the obvious intention: to digitalise healthcare including nursing and thereby to improve it.
There is, however, also a lot of criticism. Lots of medical device manufacturers are also unaware of the consequences of the law for them.
Click here for the 172-page draft of the DVPMG (german) of 17 March 2021 including the justifications and here for the HTML version of the DVPMG as it was passed (german)of 3 June 2021.
You can download the differences between the draft and the resolution by the committee here (german).
The Law on the Digital Modernisation of Healthcare and Nursing Care aims to expand care with digital health applications and to expand these to nursing care. The goals are:
The law creates the necessary legal requirements and incentives to achieve these goals.
Digital nursing care applications should be reimbursed by the health insurance providers in the same manner as digital health applications.
Examples of digital nursing care applications of this type include:
The data on patients (who require nursing care) should be integrated into the electronic patient file (ePF). Patients must be able to access this ePF via a “stationary terminal device”.
From 2023 this also applies to an additional electronic patient summary. This also includes the emergency details.
Medication prescriptions should be electronic to a greater extent.
Telemedicine, in particular video consultations and other digital communication between nursing care professionals and those receiving nursing care should be enabled and promoted.
The technical requirements, in particular the telematics infrastructure, should be created and further expanded.
Many medical devices should or must offer open interfaces.
The Federal Office for Information Security (german)(Bundesamt für Sicherheit in der Informationstechnik, BSI) should be involved in the security checks to an increased extent.
Doctors in private practice no longer need to complete data protection impact assessments is they connect their practices to the telematics infrastructure in a manner consistent with the law.
This chapter sets out the details of the DVPMG. If you are not interested in these, scroll down to the fourth chapter which sets out the consequences for the medical device manufacturers.
The DVPMG amends a large number of laws:
The following sub-chapters set out the most important changes.
The most extensive changes introduced by the DVPMG relate to Volume V of the Social Insurance Code.
The DVPMG makes numerous changes and additions to Volume XI of the Social Insurance Code. These include the new digital nursing care applications, among other things. Patients who require care are now entitled for these to be reimbursed too.
A requirement here, too, is that BfArM considers the digital application to be necessary and has included it in a new register of digital nursing care applications. Reimbursement is also limited to EUR 50 per month.
“A digital nursing care application is an application (typically software) that is essentially based on digital software which is intended by the manufacturer to be used by persons who require care or their relatives to interact with one another” or “to decrease the reduction in independence or abilities of the person who requires care and counteract a worsening of the need for care unless the application is covered by health insurance or another responsible payer as a result of a disease or disability.”
according to Volume XI of the Social Insurance Code, Section 40a
These nursing care applications may also be used as part of nursing care consultations.
Like Digital Health Applications, (german) digital nursing care applications must satisfy quality criteria relating to:
The DVPMG makes the following changes to the Regulation on Digital Health Applications, among others:
right of BfArM to request penetration tests and a certificate for an IT security management system
Read more about the requirements of the Regulation on Digital Health Applications here.
The DVPMG also amends other laws. Because of the option to issue electronic prescriptions, this primarily affects laws relating to medicinal products.
This chapter sets out the requirements of manufacturers. Readers in a hurry can jump straight to the summary in sub-chapter f).
Manufacturers are obliged
“To document changes to the digital health applications. The Federal Institute for Drugs and Medical Devices can request that documentation be submitted if the Federal Institute for Drugs and Medical Devices becomes aware that the manufacturer has not met their notification obligation according to sentence 1.”
Volume V of the Social Insurance Code, Section 139e
This documentation should be a matter of course. The right of BfArM to request this documentation has now been clarified.
Interoperability is an explicit quality feature of the medical device. Through legal regulations, the ministry can regulate the
“requirements of interoperability and the fulfilment of the obligation to integrate interfaces [...]”
Volume V of the Social Insurance Code, Section 139e(9)
Interoperability relates to interfaces with electronic patient files and electronic patient summaries.
There are also new requirements for the interoperability of implants and remedies that already “transfer data about the insured person to the manufacturer or third parties electronically via publicly accessible networks”.
The additional interoperability requirements often lead to changes to the devices.
Certain medical devices must offer a new interface. MDCG 2020-3 makes clear that a “new channel of interoperability” is a substantial amendment. This removes the “inventory protection” for all digital health applications that were marked under the MDD.
Combined with the costs of implementing the interface and switching to MDR and the limited availability of notified bodies, this could be an existential problem for Digital Health Application manufacturers. This is precisely the opposite of what the legislator was planning.
The BSI is empowered to establish the data security requirements of digital health applications on an annual basis. From 1 June 2022, it must define testing procedure and/or corresponding certificates with which the requirements of the GDPR are demonstrated (see GDPR Article 42).
BfArM can request penetration tests and security reports. From 1 January 2022 it can insist on a certificate for an information security management system. This also applies for digital health applications that have already been included in the register.
The legislator was aiming to strengthen the market for digital health and nursing care applications. There are new opportunities for manufacturers:
Manufacturers should do the following to satisfy the requirements of the DVPMG:
The German Electrical and Electronic Manufacturers' Association has complained (german) that DVPMG is not a breakthrough as it is just one numerous individual measures but there is no identifiable overarching strategy.
Criticism from Bitkom is in a similar vein and notes that a digital restart in a modern, digital healthcare sector is needed. The law is not sufficient.
They also claim that the restriction on video consultations to 30 percent is not appropriate during an epidemic [source].
The medical profession is warning about too much digitalisation (german). The arguments are the ones that are to be expected:
Dr Doris Pfeiffer, Chair of the Central Federal Association of Health Insurance Funds, also things that the increase in the power of gematik is a problem (german).
“gematik is creating increasing numbers of direct interfaces with and access points to insured persons, giving it a direct influence over the way in which the insured persons experience the digitalisation of the healthcare system, understand their health, decide which routes to take and use devices. This puts them in a position to bypass key stakeholders such as the doctors and health insurance providers. […] A gematik which not only tests and certifies the applications to be marketed practically as a state sub-department but also simultaneously develops and markets its own devices should definitely be rejected.”
As usual, criticism comes from all directions. The criticisms are:
It’s easy to criticise, but balancing out the interests of the lobbyists is an almost impossible task. The complexity of the rules is difficult to master. It’s no coincidence that the draft of the amending law runs to over 170 pages.
Many of those who are complaining about the law are precisely the ones who have caused Germany to fall behind in the digitalisation of the healthcare sector by blocking initiatives and pursuing their own individual interests.
Many of the processes in the healthcare sector with its silos are inefficient and embarrassing. Four million people who require care cannot continue to be treated using last century’s approaches. The ruling by the Federal Labour Court awarding minimum wage to foreign nursing staff is exacerbating the situation.
We should welcome any attempt to drive this complex system forwards. We can no longer continue as we always have.
We should therefore recognise that experts looking in from outside, such as the Swiss professor, Dr Andrea Bellinger, envy Germany for what Jens Spahn and his ministry have managed to do. Ms Bellinger refers explicitly to the DVPMG.
Do you need help to get your digital health application or digital nursing care application listed in the BfArM register? We’d be happy to help. Get in touch using the contact form.