user-friendliness and accessibility

[suchona.kani.z]

This means that in addition to the people in need of care, volunteer carers - such as relatives - can also be considered as a target group for users of a DiPA.

When developing DiPA, it is important that the application benefits those in need of care in one of the following areas:

Mobility,
cognitive and communicative skills,
behaviors and psychological problems,
self-sufficiency,
Coping with and independently dealing with demands and stresses caused by illness or therapy,
structuring everyday life and social contacts,
household management or
Stabilization of home care.
A key feature of a DiPA is still its main digital function. If it is necessary for the purpose of the application, it can also contain hardware such as sensors or devices. In addition, in order to fulfil the purpose or cameroon consumer email list​ for personal assistance or specific instructions for the DiPA from third parties, it may be necessary to combine the digital application with additional support services from outpatient care services. A maximum of 50 euros per month can be reimbursed for these support services together with the expenses for the DiPA.

The regulatory requirements for a DiPA are based on the principle that only applications that are safe and easy to use can be successful in the field of long-term care. The overarching requirements for a DiPA are the

safety and functionality,
data protection and data security,
interoperability and
the quality.
DiPAs do not have to be medical devices - but they can be. The only difference is that the aspects of safety and functionality for medical devices are considered to have been met due to the conformity assessment procedure according to the Medical Device Regulation (MDR), while various requirements must be observed for non-medical devices. The safety criteria for non-medical devices must be demonstrated in accordance with Annex 1 of the Digital Care Applications Regulation (DiPAV). This is a questionnaire with yes/no statements, all of which must be marked as correct in order to meet the requirements.

Appendix 1 mainly contains specifications for the manufacturer's process design. A quality management system with risk management and defined product life cycle processes is required. In order to demonstrate compliance with data protection and data security requirements, manufacturers must submit certificates from the Federal Office for Information Security (BSI) from 2024. By then, the appendix to the Digital Health Applications Ordinance (DiGAV) on data protection and security must be transferred to DiPA. DiPA manufacturers also require a certificate for the implementation of an information security management system (ISMS) in accordance with ISO 27001 and must carry out a penetration test to demonstrate a secure system at the time of application.

The further quality requirements are defined in Annex 2 of the DiPAV. They include requirements for the

interoperability,
Robustness,
consumer protection,
age-appropriate usability,
Support for those in need of care and those using it,
Quality of care-related content and the
Safety of those in need of care (patient safety).
With regard to the requirements for interoperability, DiPAs must be able to output human-readable, printable and machine-readable, interoperable data. They also require an interoperable interface for data exchange with medical devices or wearables. Manufacturers should adhere to standards with regard to user-friendliness and accessibility: To check that the application is self-explanatory, free access data for the DiPA must be made available to the BfArM when the application is submitted. To support users, training material must be available, for example, and user inquiries must be answered within 24 hours.