Articles from Dr. Christoph Renz

All relevant medical measures are documented in the patient file. According to Section 630g of the German Civil Code (BGB), patients have the right to inspect their medical records. This right is a concrete form of the principle of informational self-determination. However, the right of access is not unlimited, but can be denied by the treating physician in individual cases.

It has been disputed for some time whether a doctor requires a manufacturing authorization under pharmaceutical law for an autologous fat transplant that he performs in his practice.

What should be done if the MD determines that the requirements of an emergency level are not met?

The legally compliant agreement and billing of elective services repeatedly causes difficulties for hospital operators. It is particularly annoying when patients can refuse to pay for elective services for formal reasons because no effective contract has been concluded. For this reason, particular importance should be attached to the formal conclusion of a contract with the patient.

As of 02.12.2024, the ability to prescribe dressings at the expense of statutory health insurance for wound care will change. Manufacturers of dressings should check whether the products they manufacture can continue to be prescribed as dressings or whether they fall under the newly created category of other products for wound treatment.

The Federal Supreme Court has now ruled on an all too tiresome issue: a practice can demand a cancellation fee from a patient who does not show up for an agreed treatment appointment or cancels it at short notice (provided certain conditions are met).

Before a distributor is allowed to make a medical device available on the market, they must check whether the product complies with certain regulatory requirements. According to Art. 14 para. 1 of the Medical Device Regulation 2017/745 EU (MDR):"When making a device available on the market, distributors shall act with due care in relation to the applicable requirements."

Legacy devices may continue to be placed on the market in accordance with the new transitional provisions of the MDR (Art. 120 MDR) since the amending regulation of the MDR of 23.03.2023 if and as long as no significant change in the intended purpose or design has been made. Against the background of the new Art. 120 para. 3c lit. b MDR, the question therefore arises as to when a change in the intended purpose or design is "substantial".

A legal opinion commissioned by the Bundesverband Deutscher Privatkliniken e.V. (Federal Association of German Private Clinics) and various providers of rehabilitation facilities comes to the conclusion that the latest reform of Section 15 SGB VI is contrary to European law and unconstitutional due to a breach of competition law. In particular, the statements of the experts Brosius-Gersdorf and Gersdorf on European competition law are convincing and should encourage the legislator to reconsider the new occupancy and remuneration system:

In its ruling of 27.04.2022 (B 1 KR 15/21 R), the BSG ruled that hospitals may not outsource essential services of their care mandate to third parties:

Hospitals are often confronted with the problem that treatment is no longer medically necessary and the patient should actually be discharged to rehabilitation or a nursing home. However, places in rehabilitation facilities and nursing homes are scarce, so patients increasingly remain in hospital until a place becomes available. However, these costs are not covered by the health insurance company; instead, the health insurance companies or the MD complain about incorrect occupancy.

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