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10. Sep 2021 Adapted products - new obligations for healthcare professionals § 9 MPDG paragraph 1

A special regulation came into force for healthcare professionals with the Medical Devices Implementation Act (MPDG), which creates new obligations for daily work processes.

Medical and social law
7. Jul 2021 EU AI Regulation

With the current draft of an AI Regulation 2021/0106 (COD), the EU Commission has - as far as can be seen - presented the world's first comprehensive legal framework for the regulation of AI. The regulation is due to come into force at the end of 2022 - according to the EU Commission's plan. However, the EU Parliament and the Council still need to be involved beforehand. The legislative process is therefore not yet complete and there may still be changes. Nevertheless, it is already very important for manufacturers to incorporate the expected upcoming regulations into their own product planning. Here is an initial overview of the AI Regulation:

IP/IT Stuttgart
30. Jun 2021 Open source projects: Automated compilation of license information FOSS

In the context of projects that contain free and open source software (also: "FOSS"), various requirements must be met. One of these is to compile license information and copyright details and distribute them together with the software. How can this be done as automatically as possible?

IP/IT Stuttgart
23. Jun 2021 Structural checks

Application by 30.06.2021 or 15.08.2021? What then?

Medical and social law
10. Apr 2021 Opportunities and risks when deploying foreign nursing staff Recognition of the foreign qualification

The profession of healthcare and nursing is one of the so-called shortage occupations. Politicians have recently responded to this shortage with the "Concerted Action for Nursing". The aim of this campaign is to improve working conditions for nursing staff, but also to counter the shortage of staff. One of the points of the federal "Concerted Action for Nursing" initiative is the recruitment of already trained specialists from abroad.

Medical and social law
5. Mar 2021 What changes does the IPReG bring, especially for outpatient intensive care services? 1. what are the most important key points of the IPReG for service providers?

The Intensive Care and Rehabilitation Reinforcement Act (IPReG) came into force on October 29, 2020 and has now been in force for well over half a year. It is probably one of the most controversial legislative projects at the moment and has been met with criticism, particularly from those affected.

Medical and social law
11. Feb 2021 DiGA and the app on prescription Report on the event from 10.02.2021

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.

Medical and social law
4. Feb 2021 General terms and conditions for apps

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

IP/IT Stuttgart
2. Feb 2021 Artificial intelligence (AI) and machine learning (ML) Legal framework for the use of training data

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?

IP/IT Stuttgart
27. Jan 2021 Organizational requirements for successful radiation protection in hospitals, medical care centers and medical practices

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.

Medical and social law
27. Jan 2021 Weaning only possible after prior habituation? Weaning only after prior habituation

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.

Medical and social law
31. Dec 2020 Further legal changes and additions to association and foundation law at the turn of the year 2020/21 with regard to measures to combat the effects of the COVID-19 pandemic

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.

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