Meeting of the Working Group on Diagnostics
The 13th meeting of the Working Group on Diagnostics was held in Berlin on 8 March 2013. The agenda included discussion on the European Commission’s proposal for a regulation on in vitro diagnostic medical devices and on the individual health services that German doctors and psychotherapists can offer their patients with statutory health insurance on a private-patient basis.
At its previous meeting in October 2012, the working group looked briefly at the European Commission’s proposal for a regulation on in vitro diagnostic medical devices that had been published shortly beforehand. The working group’s experts dealt with this proposal in greater depth at their meeting in March and identified topics and problems that will be covered in a statement to be published in the coming weeks.
The working group also dealt with the topic of individual health services last year (please see the June 2012 newsletter). The meeting participants welcomed the decision by the Federal Government to regulate such services under the Patients’ Rights Act and to reject the tough motion in the Bundestag by the SPD parliamentary group. The Patients’ Rights Act came into force on 26 February 2013, establishing regulations on the treatment contract, which has been introduced as a sub-category of the service contract, in sections 630a to 630h of the Civil Code. Under the new law, doctors will have to provide patients with comprehensive information on individual health services and obtain patient consent before carrying out these medical services. This will improve patients’ rights as regards individual services offered by doctors. Members of BIO Deutschland are welcome to request a copy of the minutes of the meeting from the association’s office.