Current articles on Medical and social law

2. Apr 2020 Help for hospitals through COVID-19 Hospital Relief Act? Compensation payments to hospitals due to special burdens caused by COVID-19

The COVID-19 Hospital Relief Act is intended to support all companies and individuals working in the healthcare sector in coping with the coronavirus crisis. The aim is to compensate for loss of revenue, reduce bureaucracy and impose sanctions. Whether the COVID-19 Relief Act will do justice to this will only become clear in the coming weeks. Initial doubts are being raised.

Medical and social law
19. Mar 2020 Quality assurance agreements with distributors of medical devices

Regulation (EU) 2017/45 on medical devices (MDR for short) lays down regulatory obligations for distributors of medical devices for the first time. With this regulation, the European legislator is pursuing the goal of a smoothly functioning internal market for medical devices while at the same time ensuring quality and safety to protect the health of patients, users and third parties.

Medical and social law
19. Mar 2020 Quality assurance agreements between suppliers and manufacturers of medical devices

Regulation (EU) 2017/45 on medical devices (MDR for short) requires manufacturers to have a quality management system and a post-market surveillance system in place, which should be adapted to the risk class and type of device in question. Furthermore, a risk management system and a system for reporting incidents and safety corrective actions in the field must be set up. These high quality and safety requirements for medical devices are intended to dispel general safety concerns about these products in particular.

Medical and social law
18. Mar 2020 Coronavirus newsletter and the impact on intensive care services

The coronavirus is keeping everyone on their toes at the moment, especially in the healthcare sector. In addition to the problem of increasingly scarce protective clothing, intensive care services, among others, have recently been increasingly confronted with various employment law issues due to the coronavirus. This involves a large number of cases, the most important of which we have selected below.

Medical and social law
11. Mar 2020 Increased requirements for custom-made products in accordance with the MDR

The entry into force of the MDR in May 2020 will also place stricter requirements on custom-made products. In addition, the MPDG, which replaces the Medical Devices Act in May 2020, provides for more precise regulations on the required written prescription.

Medical and social law
14. Nov 2018 Bundestag adopts new regulations for the remuneration of home nursing care

On November 9, 2018, the Bundestag voted on the Nursing Staff Strengthening Act (PpSG). The law, which essentially aims to improve the situation for nursing staff in the care of the elderly and sick, also contains some interesting new regulations for home nursing care, some of which were only included in the law shortly before the end of the legislative process through amendments (Bundestag printed paper 19/5593).

Medical and social law
30. Aug 2018 Injunctive relief against statements made by the Medical Service of the health insurance funds in expert opinions

According to a recent decision by the Reutlingen Social Court (decision of 13.08.2018 - S 1 KR 414/18 ER), which was obtained by VOELKER, action can be taken against false factual claims in expert reports or expert opinions by the MDK by way of an injunction.

Medical and social law
28. Jul 2016 Incidents - an acid test for risk management User error as an incident

No medical device is free of risks. Dealing with fatalities and serious effects on the health of patients presents companies with ever greater challenges at a time of great political and social pressure on medical technology. This development places the highest demands on domestic and international communication with authorities, distributors and users and requires well thought-out crisis management that focuses on the manufacturer's risk management system. An overview of existing and upcoming obligations and liability risks was provided at the Medical Devices 2016 mini-symposium on June 29 in Reutlingen.

Medical and social law
2. Dec 2015 When does your medical app need a CE marking in Germany? And which rules apply?

You are developing an application for a mobile phone or another stand-alone software with a medical purpose – a “medical app”. You are probably already aware that the “Medizinproduktegesetz” might apply to your medical app in Germany. But does it really? When exactly? And does it apply to the complete app or just to certain modules of your app?

Medical and social law
21. Sep 2015 IT security law in hospitals

The "Act to Increase the Security of Information Technology Systems" (IT Security Act) came into force on July 25, 2015.

Medical and social law
11. Aug 2015 Ensuring medical care in rural areas - new opportunities for municipalities and districts New opportunities for municipalities and districts

On July 23, 2015, the Act to Strengthen the Provision of Care in Statutory Health Insurance (SHI Care Strengthening Act) came into force. One of the aims of this law is to respond to the looming shortage of doctors in rural areas. The current finding here is that more and more practice owners are unable to find a successor and are having to close their practices. The law therefore contains incentives for doctors to set up in rural (underserved) areas. On the other hand, it creates opportunities for municipalities to set up medical care centers (MVZ) themselves and thus participate as a new "player" in outpatient medical care.

Medical and social law
28. Jul 2015 Current need for action to convert supply contracts

Current developments in medical device law require adjustments to the contracts normally used in supply chains. We would like to draw your attention to some of these points with this information. In addition, we would like to draw your attention to a number of erroneous or ineffective clauses in contracts for medical device supply chains, which we have recently encountered more frequently in our advisory practice:

Medical and social law

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