Since the beginning of January, manufacturers of Digital Health Treatments (DIGA) who can be determined by doctors are no longer present for the use of healthids. Diga manufacturers should offer their insured person for authentication. However, according to BFARM, it does not change for DIGA, which are already approved and listed in the directory for the Federal Institute for Medicine and Medical Devices (BFARM). The reason for this is according to the BFARM response that “the request was first included in Appendix 1 of Digav and hence it has already been applied for Diga listed. The need persists”.
Forget healthy?
According to the change in the ordinance for the Digital Health application (DIGAV), Diga has to meet the Federal Office for Information Technology (…) to “Data Safety (…) requirements,” is called Digav. First of all, however, it was not taken into account that self -development would have been abolished according to Appendix 1 of Digav that Diga Health ID would have to be supported to really approve.
Insurance individuals should be certified in Diga “via healthide, as reports from the Federal Office for Medicine and Medical Device (BFARM). However, after a change in the legislature, the health has forgotten to keep in mind the health.
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“For this reason, ‘digital health treatments of the requirement should be certified by GKV insured individuals, which according to the individuals used by the digital health application and according to the fifth book of Social Code 1 and 291 paragraphs 8,” Completion out of Appendix 1 in Digav “, according to BFAR, according to BFAR, according to BFAR, according to BFAR, according to BFAR, according to BFAR, according to BFAR, Digital Health, Digital Health Individuals used by the Digital Health application should be certified as compared to individuals used by the application. ” Dressing the speaker for second regulation to replace Digw (PDF), which is dated 3 January.
“Now with the second ordinance available in the draft, the regulation from Appendix 1 has been postponed to the direct regulation part of the regulation,” says a spokesman of the Ministry of Federal Health at the request. Asked whether the changes in the DIGA manufacturer are also affected by the changes of the DIGA, at their request to write data from the insured after their consent, or at their request to write EPA, BMG replied: “The use of digital identity is also technical prejudice for the responsibility of the manufacturer of the DIGA, which is to enable the export of electronic patients.
“It is important that the future government is taking the current government project to amend the Diga ordinance. The draft of the lecturer was already available for proper changes. Because from a purely formal point of view, a authentication should not be used by the Diga provider,” Advocate Dr. Tilman Ditriich explains. The manufacturers are already bound to transfer the data generated in the DIGA through an interface through an interface to the patient’s consent to the electronic patient file, also necessary.
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