The Digital Care Act: first reading in Federal Parliament

Category: product safety, data protection, cybersecurity Industry: healthcare Author: Year:
Miriam Schuh

The Digital Care Act (PDF) had its first reading in German Parliament on 27 September 2019, followed by further deliberations in the Committees. The goal of the Act is to promote digitization in the health care sector, e.g. by implementing:

  • prescription-based health apps
  • online video consultations
  • mandatory integration of pharmacies and hospitals into the telematics infrastructure
  • introduction of electronic prescriptions for therapeutic remedies and aids
  • higher fees for electronic physician's letters

Necessary changes in terms of data protection law, e.g. for the digital patient file, are to be covered in a separate statute, and not in the Digital Care Act.

Higher requirements for medical professionals

The Digital Care Act aims to make health care better through digitization and by connecting the various actors in the health care sector.  To this end, the Act requires actors in the health care sector to engage in intensive cooperation in order to create an improved digital infrastructure. For example, pharmacies and hospitals will be required to connect to the telematics infrastructure (TI) by 1 January 2021 at the latest. Midwives, physical therapists and nursing and rehabilitation facilities will have the option of connecting to the TI voluntarily. Physicians who still refuse to connect to the TI will have their fees cut by 2.5% as of 1 March 2020 (up from 1% today). Now that electronic prescriptions have been gradually adopted with the Act to Improve Safety in Medicinal Products and electronic certificates of disability have been introduced upon presentation of the 3rd Bureaucracy Relief Act, the Digital Care Act will enable electronic prescriptions for therapeutic remedies and aids in the future.

Electronic prescriptions for therapeutic remedies and aids

Accepting digital prescriptions, which is to take place through the TI in the long run, requires a way to verify the identity of home health care providers so that they can access the TI.  For this purpose, home health care companies and providers will be entered into the electronic Health Care Professional Register, which has yet to be established, and will be issued electronic health professional cards (e-HPCs). Under the E-Health Act, e-HPCs had previously been reserved for physicians, dentists, psychiatrists, physical therapists and pharmacists. Like the electronic health care card, this card will contain a microchip which enables authentication (electronic identity verification), encryption and electronic signature, exchanging data in the TI planned by Gematik. Industry associations have also proposed an alternative accreditation procedure through which home health care providers can be accredited as an institution. This procedure can be based on the existing electronic card for medical practices and institutions (Security Module Card Type B, or SMC-B), which allows medical practices and hospitals to access the TI.

Conclusion

The Digital Care Act takes another step towards digitization of the health care sector in general, and patient care in particular. In the long run, the introduction of digital prescriptions will make health care more effective by eliminating media disruptions and connecting health care providers. However, it will take some time before the necessary steps can be taken to issue electronic health professional cards as planned and to connect the various actors to the TI, especially since some details are still being debated. Home health care providers should keep an eye on progress with the proposed accreditation procedure and should obtain accreditation and connect to the TI as soon as possible so as not to find themselves at a competitive disadvantage relative to pharmacies which also provide medical aids.  

[October 2019]