BAYOOMED
  • Portfolio
    • Solutions
      • Mobile Medical Apps
      • Connectivity
      • Cloud based Solutions
      • Desktop and Web Solutions
      • Artificial Intelligence
      • Cybersecurity
      • Agile Software Development
      • Verification and Validation
    • Product Launch
      • Digital Health Applications (DiGA)
      • BAYOOCARE
    • Support
      • Regulatory Support
      • Risk Management
      • Clinical Evaluation
      • Quality Management
      • Usability Engineering
      • Approval
      • Classification
      • Post-Market Surveillance
  • Medical Software
    • Product Development
      • Requirements Management
      • Software Architecture
      • Software Engineering
      • Embedded Software
      • Verification and Validation
  • About Us
    • About BAYOOMED
      • Team
      • Certification (ISO 13485 Certificate)
      • Medical Device Experts
    • About BAYOONET
      • BAYOOSOFT
      • BAYOOTEC
      • BAYOOCARE
    • Success Stories
  • News
  • Jobs and Career
  • Search
  • Menu

Digital care apps: The trend around DiPA 2022

Digital care applications – in german DiPA for short – are currently shaping the medical technology sector alongside digital health applications (DiGA). Why is this so? Among other things, because the reimbursability of DiPA has been regulated by law since the beginning of 2022. What are the benefits of DiPA? What is worth knowing about the legal regulation? And what are the differences between digital care and health applications?

The purpose of DiPA is to stabilise or improve the state of health of people in need of care. In doing so, the applications support those in need of care, accompanying persons and caregivers in everyday life. DiPA can also be used to improve communication between relatives and caregivers.

A person suffering from dementia, for example, is supported via DiPA with personalised memory games, while relatives are supported with advice or digital checklists.

Good to know

Digital care applications are not medical devices by law. According to the Social Code, they are “applications that are essentially based on digital technologies […]” (cf. § 40a SGB XI Digital Care Applications).

Unlike digital health applications (DiGA), which are CE-marked medical devices of risk class I or IIa, DiPA are thus not subject to the regulatory requirements of the MDR.

Legal regulations – What you need to know about DiPA

For users applies:

Legally, people in need of care are entitled to a supplementary benefit from a DiPA if necessary in the individual case. The decision on the entitlement to reimbursement lies with the long-term care insurance fund. A price cap of up to 50 euros per month can be claimed for reimbursement. If the DiPA is more expensive, users have to pay the additional costs themselves.

For manufacturers applies:

Inclusion in the DiPA directory is not yet possible, as the Federal Institute for Drugs and Medical Devices (german: BfArM) has yet to create the basis. However, it is certain that a complete, digital application for inclusion in the list must be submitted to the BfArM. Within three months, the institute will decide whether to approve or reject the application.

It is also worth knowing that the remuneration amount as well as the technical and contractual framework conditions of the DiPA must be negotiated with the german Spitzenverband Bund der Pflegekassen within three months after inclusion in the directory.

DiPA, DiGA – or both?

An application can – according to the current status – be both DiPA and DiGA. Only the requirements for the application differ. However, if the app offers functionalities that are required for both DiPA and DiGA, approval and listing in both categories is possible.

It is up to the service providers to decide in which way the application can be reimbursed.

Requirements for the DiPA

The legal text § 78a SGB XI compactly summarises the applicable regulatory requirements.

Requirements must be met in terms of:

  • safety, functional capability and quality
  • data protection and data security (according to the state of the art)
  • nursing benefit

Quality features are also

  • accessibility
  • age-appropriate usability
  • robustness
  • consumer protection
  • quality of care-related content
  • and support in the use of the DiPA

What is the difference between DiPA and DiGA?

According to the BfArM, DiGA assist in diagnosing, monitoring, treating or alleviating diseases, injuries or disabilities. Compensation for injuries or disabilities can also be made possible.

DiPA, on the other hand, are aimed specifically at people in need of care as well as their caregivers (relatives as well as care services). In addition to the target group of the applications, however, there are other significant differences – an overview:

News

  • Women at BAYOOMEDGrowing Femtech: How Apps like MyIUS effect a change20. December 2022 - 14:53
  • Banner der HIMSS 2022Meet us at HIMSS 2022 in Helsinki10. June 2022 - 18:29
  • Eine Frau und ein Mann sitzen mit dem Tablet und Notizblock in der HandBAYOOMED @TT SDC in Brussels10. May 2022 - 12:26
Your contact at BAYOOMED

Miriam Schulze
CEO
miriam.schulze@bayoo.net

Darmstadt
Europaplatz 5
64293 Darmstadt

Munich
Aidenbachstraße 54
81379 München

Berlin 
Mariendorfer Damm 1-3
12099 Berlin

Contact:

Phone: +49 (0) 6151 – 86 18 – 0
Fax: +49 (0) 6151 – 86 18 – 150

E-mail: info@bayoo.net
Support: support@bayoo.net
Jobs: jobs@bayoo.net
Press: presse@bayoo.net

© Copyright - BAYOOMED
  • Contact
  • BAYOONET AG
  • Data Protection Policy
  • Imprint
  • Kontakt
  • BAYOONET AG
Digital Revolution for dentistry: From the idea to OccluSense® BAYOOMED @DMEA 2022
Scroll to top