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Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Legitimately categorizing software in the healthcare sector is complex. According to European medical devices law, software can be considered a medical device. The decisive factor is whether the software is used for directly controlling a therapeutic or diagnostic medical device or as stand-alone software that achieves specific medical purposes, as they are described in the legal definition of a medical device. A contribution of the software to diagnosis or therapy can be sufficient for the categorization; it does not have to provide the complete diagnosis or the complete therapy itself.This principle will continue to be the same with the new Regulation on Medical Devices (EU) 2017/745, even though the classification rules have been more closely and more specifically tailored to software and more stringent requirements for essential safety and performance requirements have to be met.

Digital health products and services have started to fundamentally change healthcare and prevention. Products intended for a medical use require CE-marking and potentially certification (ISO 13485) of the company. Startups play an important role in the development of new digital products and services. Two startups share their experience with these processes. Becoming a part of standard care and hence being reimbursed is a challenge for startups. For this reason, startups pursue alternative sources of income, too. The statutory health insurance's procedures for assessing new products and services are perceived as long. Startups are required to provide evidence of the benefit of their product at an early stage in the procedure. This requires time-consuming and costly studies. Startups would therefore appreciate support in generating this evidence, e. g. through adequate procedures for testing.

Infection prevention is one of the main tasks of the public health services. The "Protection against infection act" places all medical institutions and facilities for children (kindergartens and schools) under the obligation to assume responsibility and to cooperate. Duties of the institutions are described, and public health services are obliged to perform hygiene control visits.Regarding medical institutions, the guidelines of the German Commission on Hospital Hygiene and Infection Control have to be observed, and the counties were obliged to publish hygiene enactments. Subsequently, good improvements in hygiene management in medical institutions were achieved. In schools, however, severe hygienic problems (i.e. sanitary hygiene, indoor air hygiene) are detected, without any improvement - obviously due to a missing sense of responsibility in the school community. Causes for poor behaviour prevention (hand hygiene, ventilation) and missing situational prevention (i.e. cleaning) are discussed. Without reversion to the obviously needed but nearly forgotten subject school hygiene, obligatory guidelines and the assuming of responsibility, permanent improvements cannot be achieved., (© Georg Thieme Verlag KG Stuttgart · New York.)

The effectiveness of the risk management systems established by medical device manufacturers and health-care facilities is clearly mitigated by European and national legal provisions. Laws, regulations and authorities prevent the systematic exchange of much safety-relevant information. The obligation to report adverse events is suspended for many relevant risks associated with medical device use. Reporting into the vigilance system is of little avail for users. Reporting even may endanger the information provider. The federal fragmentation of the German vigilance system poses a risk for patients. Risk management in health-care facilities without risk policy is dangerously incomplete., (© Georg Thieme Verlag KG Stuttgart · New York.)

Sectorally segregated healthcare structures are seen as a major reason for deficits in quality and efficiency. With the introduction of §§ 140 a ff. SGB V, the sectoral splitting into outpatient, inpatient and rehabilitative services will be eliminated. This is especially true for the requirements of state-of-the-art multidisciplinary and comprehensive pain therapy. Through this form of contract competition and competition for the best idea, incentives shall be created for economic behaviour of market participants, above all the efficient use of limited resources and allocation of healthcare resources based on need. Selective contracts are essential competition parameters for continued innovative development of the healthcare system. They enable statutory healthcare providers to offer their insurants innovative treatments which are not available in standard care. Agreements can be made concerning higher levels of quality and healthcare services, incentives for economical behaviour and success-based payment models. The key idea is the orientation on the needs of the insurant. The successful realisation of innovation in pain therapy is described using a practical example. Professional contractual partners, high quality information and communication, the taking over of responsibility for treatment and cost effectiveness are factors essential the success of innovative treatment concepts.

The concept of identifying appropriate scientific and regulatory principles to ensure rapid availability of pandemic influenza vaccines when needed were already developed starting in the year 2003. These principles allowed licensing of three so-called mock-up vaccines far ahead of any real presenting pandemic event. Those licenses (Marketing Authorizations) were immediately adapted to the novel H1N1 strain shortly after its identification in April 2009 ensuring that as early as September 2009 large parts of the German as well as of the EU population had access to licensed products which had undergone sufficient evaluation before first use in humans. In contrast, for pandemic vaccine concepts without a previously licensed mock-up version it generally took twice as much time to accumulate data supporting the granting of a Marketing Authorization. This article describes in detail the translation of concepts of producing, testing, and licensing of pandemic influenza vaccines into practice under real conditions.

Compared to other European countries' health systems, the NHS is very different. Finance by taxes, standards set by frameworks and statutory bodies to monitor nationwide the outcome, are virtually unknown on the Continent. For the patients there are considerable differences in how they are referred to psychotherapy and receive their treatment based on guaranteed standards. Health professionals identified with the NHS have to cope with a plethora of government directives.