Germany may have acquired a reputation for having a challenging environment with which to operate a digital health business, with critics pointing to issues such as a strict data protection regime and the nature of the German health insurance sector. In this article however, Marc L. Holtorf, Partner and Head of German Intellectual Property and Life Sciences at Pinsent Masons Germany LLP, presents a more positive view of the status of digital health in Germany, and looks at some of the initiatives being taken by the German federal Government to support digital health. / read more

Outsourcing, cloud computing and the general use of external service providers has been subject to regulatory obstacles in Germany for quite some time. Persons subject to professional secrecy, such as medical practitioners, pharmacists, and psychologists etc, need to comply with strict requirements under the German Criminal Code. This has led to various discussions and workarounds, but also to a high degree of uncertainty. Thanos Rammos, Salary Partner at Taylor Wessing, considers the impact of proposed amendments to the German Criminal Code approved by the Bundestag on 29 June 2017 which, if approved by the Bundesrat, could enable companies from the medical and insurance sectors to make wider use of outsourcing and cloud services. / read more

On 19 October 2016, the Court of Justice of the European Union (‘CJEU’) held that Germany’s fixed pharmacy prices constitute an unjustified restriction of the free movement of goods principle, which cannot be justified on grounds of the protection of health and human life. The ruling overturned Germany’s retail price maintenance regulation for prescription drugs. Here, Jan Schlimgen and Max Müller of Dutch online pharmacy DocMorris N.V. provide their perspective on this important ruling, which was instigated by a bonus system that a German Parkinson’s disease self-help organisation agreed with DocMorris. It was the legal action taken by the German Association for Protection Against Unfair Practices against this bonus system that led to the ruling from the CJEU. / read more

The EU General Data Protection Regulation (‘GDPR’) will apply from 25 May 2018. Due to the sensitivity of the data processed in the healthcare sector, the GDPR will have a direct impact on this sector in Europe. Dr Stefan Alich of Taylor Wessing PartG mbB describes the potential impact from a German perspective. / read more

Telemedicine presents countless opportunities for the provision of effective healthcare. Dr Marian Arning, a Lawyer at Osborne Clarke, describes the current prohibition in Germany in regards to remote treatment and the recent guidelines published by the German Medical Association that provide valuable clarity on navigating this prohibition for the adoption of telemedicine in practice. / read more

Germany’s draft eHealth bill received its first reading in the German Parliament on 3 July. The first reading of the much-debated bill has shown there is broad consensus that the bill is a first step in the right direction for further developing the infrastructure and parameters for eHealth solutions in Germany, thinks Dr Roland Wiring, Counsel at CMS Hasche Sigle. / read more

In January 2015 the German Federal Ministry of Health (‘BMG’) published the first Ministerial Draft of a bill on the ‘Law on secure digital communication and applications in the healthcare sector,’ commonly referred to as the ‘eHealth Bill.’ This draft, which the German government aims to bring into force at the beginning of 2016, is subject to scrutiny from stakeholders. A large number of politicians, associations and commentators have provided their views on the draft law, which - as Dr. Roland Wiring, Counsel at CMS Hasche Sigle, explains - seems to provide a baseline but does not appear to be the breakthrough some stakeholders had hoped for. / read more

eHealth and telemedicine applications are particularly well-developed and promoted in countries with sparsely populated regions, given that there is a practical need to do so. Does that necessarily mean that rather densely populated countries are, by their nature, lagging behind or even excluded from further development? Dr. Boris Handorn and Fabian Raddatz, LL.M. of Noerr LLP assess the situation in Germany. / read more

Germany’s Federal Health Minister Herman Gröhe announced on 31 July that the German government is to create an eHealth Council, which will aim to remove barriers to eHealth, improve the interoperability and information exchange between health IT systems and propose improvements to the legal framework around eHealth. / read more

The Federal Court, the highest civil court of Germany, has decided that, under certain conditions, an advertisement for a drug does not need to cover the ‘essential information.’ This ruling enables pharma companies to use Google AdWords in the advertising of over-the-counter (‘OTC’) drugs to the general public¹. By Jana Grieb, Counsel at McDermott Will & Emery Rechtsanwälte Steuerberater LLP, Munich. / read more