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On 10 February 2021, 46 interested parties met for the online event "The Digital Healthcare Act - DiGA and the app on prescription", which was organized by BioRegioSTERN. There was a diverse group of participants: representatives from research institutions, software and medical technology companies and public authorities showed an interest in the latest developments.

What content and topics need to be considered when drafting general terms and conditions for apps?

The existence of training data is fundamental to the training of artificial intelligence (AI) and therefore machine learning (ML). This training data is also referred to as a dataset or corpus - regardless of any differences in terminology in detail - and is often subject to legal protection, meaning that the training may result in legal infringements. What conceivable legal infringements are these and to what extent is their use permissible?

Various types of artificial radiation are used for diagnostic and therapeutic purposes in hospitals, medical care centers and radiology practices. The requirements for radiation protection are regulated in the Radiation Protection Act and the Radiation Protection Ordinance.

The billing of ventilation hours regularly leads to disputes between hospitals and health insurance companies. This is not least due to the fact that it depends on the exact documentation of the ventilation hours: The DRGs to be billed are based on whether certain threshold values are exceeded (e.g. DRG A13H is only coded if the patient was ventilated for more than 95 hours). The health insurance companies and the Medical Service check in detail whether the billed ventilation hours can also be read from the patient file.

At the turn of the year 2020/21, the federal legislator once again took action and also adopted further legal measures in association and foundation law to combat the effects of the COVID-19 pandemic.

On 17.12.2020, the Bundestag passed the "Act to further shorten residual debt discharge proceedings and to amend pandemic-related provisions in company, cooperative, association and foundation law as well as in tenancy and leasehold law". The Federal Council already approved the law on 18.12.2020. The legislator has thus responded to the effects of the SARS-CoV-2 pandemic and the regulations issued by the federal states to combat it and extended the application of the regulations on the so-called cessation of the basis of the transaction.

The "app on prescription" is now possible thanks to the Digital Healthcare Act, which introduced digital health applications ("DiGA"). However, DiGAs must comply with considerable additional requirements. Data protection in accordance with the GDPR must also be complied with. However, the already narrow permissions of the GDPR are further restricted for DiGA.

The Digital Healthcare Act introduced digital health applications ("DiGA"). This allows medical apps to be included in a directory maintained by the Federal Institute for Drugs and Medical Devices ("BfArM"). The apps can then be prescribed by doctors. This is therefore an "app on prescription".

As is well known, providers of outpatient intensive care conclude contracts with the health insurance funds (currently still individually, in future jointly and uniformly with the health insurance funds) on the provision of services, in which the remuneration is then also regulated. In accordance with. § Section 132l (5) sentence 2 SGB V new version (Section 132a (4) sentence 7 SGB V old version), the payment of salaries up to the level of collectively agreed remuneration and corresponding remuneration in accordance with church labor law regulations cannot be rejected by the health insurance funds as uneconomical. As a result, this means that service providers are entitled to pay their employees salaries up to the level of collectively agreed remuneration and that this must be refinanced by the health insurance fund.

In recent years - and not just since the coronavirus crisis - there have been more and more portals offering medical information or even medical services, such as second opinion portals, scientific information portals for patients or doctors, drug reviews and symptom checkers. Numerous new portals have emerged at short notice, especially now in Corona times, or are in the process of being created, e.g. telemedical offers, mediation portals such as appointment mediation. There are typical legal problems that need to be considered when advising such portals:

Erbringen Gesellschafter Einlagen in ihre Gesellschaft, erfolgt dies meist nach dem Verhältnis ihrer Beteiligung an der Gesellschaft; die Gesellschafter können jedoch auch davon abweichende, sog. disquotale Einlagen leisten. Dabei ist jedoch Vorsicht geboten, kann dies nach einer aktuellen Entscheidung des BFH doch zum Anfall von Schenkungsteuer führen.