Germany to Mandate E-Prescriptions by 2022

Country: GERMANY | Region: EUROPE | Type: Regulation | Keywords: #bill #bmg #cdu #digital #e-prescription #law #pdsg

PRICENTRIC BRIEF:

  • The newly formulated paragraph 360 of SGB V of the Patient Data Protection Act (PDSG) says doctors and dentists who participate in contract medical care or prescribe from clinics are obliged only to do so in digital form from January 1, 2022, with some exceptions
  • The obligation does not apply to narcotics and so-called T prescriptions, and further exceptions will be made if the electronic exhibition is not possible, in the case of at-home doctor’s visits, for example, or if the required technical services are not available, and pharmacies are likewise obliged to dispense medicinal products based on e-prescriptions
  • While the ministry will regulate the interfaces in the telematics infrastructure, an “external security report” was added, in which the security of the telematics infrastructure will be examined carefully, and contract doctors or health insurers are required to refrain from assigning prescriptions to specific pharmacies or influence the insured to redeem prescriptions in a specific pharmacy

THE DETAILS

BERLIN, Germany — The federal government is attempting to pass the Patient Data Protection Act (PDSG) presented by Federal Minister of Health Jens Spahn (CDU), which addresses a handful of regulations regarding e-prescriptions.

Immediately prior to the referral to the cabinet, Spahn announced that the federal government aims to require all prescriptions be issued in electronic form from January 1, 2022, with some exceptions. The newly added regulation requiring e-prescriptions is a surprise, since Spahn and his ministry previously said the paper prescription should be preserved. 

Originally submitted by the Federal Ministry of Health (BMG) at the end of January this year, the PDSG is meant to digitize the health care system and oblige the now nationalized Gematik to create a standard mobile phone app for transmitting prescriptions, with the capability of forwarding them on to the applications of other providers like on-site pharmacies and mail order companies.

The newly formulated paragraph 360 of SGB V says doctors and dentists who participate in contract medical care or prescribe from clinics are obliged only to do so in digital form. 

The obligation does not apply to narcotics and so-called T prescriptions, and further exceptions will be made if the electronic exhibition is not possible, in the case of at-home doctor’s visits, for example, or if the required technical services are not available, and pharmacies are likewise obliged to dispense medicinal products based on e-prescriptions.

Still, pharmacists must check whether an e-prescription prohibits delivery due to suspected misuse, as is currently the case with paper e-prescriptions.

With exclusive rights of intervention, the ministry will regulate the interfaces in the telematics infrastructure “and their use by third parties” by means of an ordinance and without the consent of the Federal Council. 

In response to allegations regarding faulty data security in the healthcare system, an “external security report” was also added, in which the security of the telematics infrastructure should be examined carefully. 

Following major protests from the pharmacy community, it was further added that contract doctors or health insurers may not assign prescriptions to specific pharmacies or influence the insured to redeem prescriptions in a specific pharmacy.

While third parties will be able to connect to TI applications, the cabinet template now states that it is not permitted for them to “collect prescriptions, also in electronic form, to mediate or forward them to pharmacies, and to request an advantage for themselves or others to get one to promise, to accept or to grant an advantage.”

To read the MoH’s statement on these regulations, please use the following link: https://www.bundesgesundheitsministerium.de/pdsg.html

 

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