New digital law: the most important points at a glance

• Electronic patient file (ePA): From 15 January 2025, the electronic patient record will be automatically available to all people with statutory health insurance - unless patients object to the creation of such a record. This will convert the ePA to an opt-out solution and ensure that it is established across the board in the healthcare system.
• Electronic prescription: The DigiG establishes the e-prescription as a binding standard in the provision of medicines. Medical practices must prove that they fulfil the technical requirements to issue and transmit prescriptions for prescription drugs electronically.
• Video consultations: The DigiG aims to strengthen telemedicine - and thus video consultations in particular. As part of this, the quantitative restriction will be lifted so that doctors can decide for themselves how many video consultations they offer. In addition, video consultations will no longer be remunerated on the basis of fixed amounts, but rather according to the type of treatment.
• Digital health applications (DiGA): Digital health applications will be more closely integrated into care processes with the DigiG. In addition, the entitlement to benefits will be extended from digital medical devices of low risk class (IIa) to products with increased risk (IIb). Risk class IIb includes implantable and/or surgically invasive products, making telemonitoring applications possible, for example. Manufacturers of digital products in risk class IIb who wish to be listed in the DiGA directory must prove the medical benefit of their application.
  DiGA access will be made easier for insured persons: in future, the required activation codes must be sent by the health insurance companies within two days.
• Assisted telemedicine: Pharmacies are to offer assisted telemedicine in future. This means that pharmacists will be able to provide advice on outpatient telemedicine services and their utilisation. They may also support patients in carrying out simple routine medical tasks during a medical telemedicine service. In addition, the provision of telemedical services will also be possible in facilities such as university outpatient clinics and psychiatric institute outpatient clinics as well as psychotherapeutic consultations.
• Interoperability: The interoperability of the various systems and technologies used is to be promoted. Binding standards and guidelines are expected in the foreseeable future.
• Digital Advisory Board: As part of the DigiG, a Digital Advisory Board will be set up at gematik, consisting of representatives from the Federal Commissioner for Data Protection and Freedom of Information (BfDI), the Federal Office for Information Security (BSI), medicine and ethics. In future, this committee will advise gematik on issues relating to data protection, data security, data utilisation and user-friendliness.

We have been supporting hospitals, health insurance companies, providers of digital health applications, medical technology manufacturers and countless other stakeholders in their endeavours to increase and secure IT security in the healthcare sector for many years.

In view of the changes introduced by the Digital Act, we offer, for example testing and certification of video consultation solutions or support manufacturers of digital digital health applications on their way to becoming a reimbursable DiGAe.g. by carrying out penetration tests and tests in accordance with TR-03161.But we also go beyond this with a comprehensive portfolio of auditing and testing services to ensure greater IT security in the healthcare sector.