[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

Filling Voice Promotion Gaps in Healthcare through a Comparative Analysis of Error Reporting and Learning Systems and Open Communication and Disclosure Policies in the United States and Germany.

Voice in healthcare is crucial because of its ability to improve organizational performance and prevent medical errors. This paper contends that a comparative analysis of voice promotion in the American and German healthcare industries can strengthen a culture of safety in both countries. It provides a brief introduction to the concept of voice in healthcare, including its impact on safety culture, barriers to voice, and the dual influences of confidentiality and transparency on voice promotion policies. It then examines the theoretical basis, practical workings, and legal aspects of voluntary error reporting and error disclosure as avenues for exercising voice in the U.S. and Germany. Finally, it identifies transferable practices that can remedy shortcomings in each country's voice promotion policy.

[Does the healthcare for rare diseases benefit from the legislative reforms?] / Profitiert die Versorgung von seltenen Erkrankungen von den Krankenhausreformen?

BACKGROUND: The founding of the National Action League for People with Rare Diseases (NAMSE) in 2010 represents the creation of a significant political platform. In addition, recent years had seen Germany and the EU adopt specific legislative measures aimed at improving healthcare for people with rare diseases. OBJECTIVE: In this article we will give an overview of the legislative reforms adopted between 2013 and 2016 and evaluate how the specific healthcare situation of people with rare diseases has been improved. MATERIALS AND METHODS USED: This article analyzes the health care legislative reforms adopted during the 18th term (since 2013) of the German lower house, the Bundestag, as well as their self-governing implementation. The analysis also extends to similar political initiatives of the European Commission. RESULTS: The impact of the recent hospital reforms on the health care received by patients or on the work of health care providers in the field of rare diseases cannot be assessed conclusively at this point (January 2017). One positive feature is that the health care coverage mandate of the university hospital outpatient departments now also comprises rare diseases. DISCUSSION: Recent legislative measures have created possibilities to improve the economic position of centers for rare diseases and university hospital outpatient departments. What these improvements will look like specifically depends on the implementation within the hospital plans of the federal states as well as on the outcome of the remuneration negotiations between university hospitals and health insurance funds.

Why Medicare Advantage Plans Pay hospitals traditional Medicare prices.

The policy community generally has assumed Medicare Advantage (MA) plans negotiate hospital payment rates similar to those for commercial insurance products and well above those in traditional Medicare. After surveying senior hospital and health plan executives, we found, however, that MA plans nominally pay only 100-105 percent of traditional Medicare rates and, in real economic terms, possibly less. Respondents broadly identified three primary reasons for near-payment equivalence: statutory and regulatory provisions that limit out-of-network payments to traditional Medicare rates, de facto budget constraints that MA plans face because of the need to compete with traditional Medicare and other MA plans, and a market equilibrium that permits relatively lower MA rates as long as commercial rates remain well above the traditional Medicare rates. We explored a number of policy implications not only for the MA program but also for the problem of high and variable hospital prices in commercial insurance markets.

Pursuing the Triple Aim: The First 7 Years.

UNLABELLED: POLICY POINTS: In 2008, researchers at the Institute for Healthcare Improvement (IHI) proposed the Triple Aim, strategic organizing principles for health care organizations and geographic communities that seek, simultaneously, to improve the individual experience of care and the health of populations and to reduce the per capita costs of care for populations. In 2010, the Triple Aim became part of the US national strategy for tackling health care issues, especially in the implementation of the Patient Protection and Affordable Care Act (ACA) of 2010. Since that time, IHI and others have worked together to determine how the implementation of the Triple Aim has progressed. Drawing on our 7 years of experience, we describe 3 major principles that guided the organizations and communities working on this endeavor: creating the right foundation for population management, managing services at scale for the population, and establishing a learning system to drive and sustain the work over time. CONTEXT: In 2008, researchers at the Institute for Healthcare Improvement (IHI) described the Triple Aim as simultaneously "improving the individual experience of care; improving the health of populations; and reducing the per capita costs of care for populations." IHI and its close colleagues had determined that both individual and societal changes were needed. METHODS: In 2007, IHI began recruiting organizations from around the world to participate in a collaborative to implement what became known as the Triple Aim. The 141 participating organizations included health care systems, hospitals, health care insurance companies, and others closely tied to health care. In addition, key groups outside the health care system were represented, such as public health agencies, social services groups, and community coalitions. This collaborative provided a structure for observational research. By noting the contrasts between the contexts and structures of those sites in the collaborative that progressed and those that did not, we were able to develop an ex post theory of what is needed for an organization or community to successfully pursue the Triple Aim. FINDINGS: Drawing on our 7 years of experience, we describe the 3 major principles that guided the organizations and communities working on the Triple Aim: creating the right foundation for population management, managing services at scale for the population, and establishing a learning system to drive and sustain the work over time. CONCLUSIONS: The concept of the Triple Aim is now widely used, because of IHI's work with many organizations and also because of the adoption of the Triple Aim as part of the national strategy for US health care, developed during the implementation of the Patient Protection and Affordable Care Act of 2010. Even those organizations working on the Triple Aim before IHI coined the term found our concept to be useful because it helped them think about all 3 dimensions at once and organize their work around them.

[Official experimental testing of biomedical products. Regulatory frame and importance of for quality, safety and efficacy]. / Staatliche experimentelle Produktprüfung von biomedizinischen Arzneimitteln. Regulatorischer Rahmen und Bedeutung für die Qualität, Sicherheit und Wirksamkeit.

The official experimental testing of biomedicinal products provides a very significant contribution to ensuring quality, safety and efficacy of these indispensable medicines. Already in the prelicensing phase or to elucidate clusters of increased adverse effects, official medicinal control laboratories are committed to perform experimental testing. The official batch release can be seen as external quality control of the manufacturer's release testing. For proficient performance in these tasks, scientific research is required, in particular on the development and refinement of test methods, and considering the continuous development of innovative biomedicinal products. This article is aimed at introducing the present thematic issue and in particular the regulatory basis of experimental product testing, and illustrates by means of several examples its great importance for the sake of the patients.

Using patient safety organizations to further clinical integration.

This article addresses why in the current context of driving toward improved value, physician groups ought to consider developing a patient safety evaluation system and reporting to a patient safety organization. The fundamental challenge to physicians to succeed in the future is to clinically integrate within their own practices, standardizing to the evidence base, and measuring their performance. In addition, it is increasingly clear that the physician office practice is a source of patient safety issues. The Patient Safety and Quality Improvement Act provides two powerful protections for data that will support and bolster clinical integration and patient safety. The protections and how to deploy them are presented.

[Quality of documentation of intraoperative and postoperative complications : improvement of documentation for a nationwide quality assurance program and comparison with routine data]. / Dokumentationsqualität intra- und postoperativer Komplikationen : Verbesserung der Dokumentation für die verpflichtende Qualitätssicherung und Vergleich mit DRG-Routinedaten.

INTRODUCTION: Complications after cholecystectomy are continuously documented in a nationwide database in Germany. Recent studies demonstrated a lack of reliability of these data. The aim of the study was to evaluate the impact of a control algorithm on documentation quality and the use of routine diagnosis coding as an additional validation instrument. METHODS: Completeness and correctness of the documentation of complications after cholecystectomy was compared over a time interval of 12 months before and after implementation of an algorithm for faster and more accurate documentation. Furthermore, the coding of all diagnoses was screened to identify intraoperative and postoperative complications. RESULTS AND DISCUSSION: The sensitivity of the documentation for complications improved from 46 % to 70 % (p = 0.05, specificity 98 % in both time intervals). A prolonged time interval of more than 6 weeks between patient discharge and documentation was associated with inferior data quality (incorrect documentation in 1.5 % versus 15 %, p < 0.05). The rate of case documentation within the 6 weeks after hospital discharge was clearly improved after implementation of the control algorithm. Sensitivity and specificity of screening for complications by evaluating routine diagnoses coding were 70 % and 85 %, respectively. The quality of documentation was improved by implementation of a simple memory algorithm.

[Midwife-led birth centres: an alternative to hospital childbirth?]. / Geburtshäuser: Versorgungsalternative zur Klinikentbindung?

After midwife-led birth centres had been included into the Social Security Statute Book (§134a SGB V) and thus become covered by German Public Health Insurance since April 1st, 2007 contract negotiations on flat rate costs have followed. Meanwhile the 2nd edition of this -agreement has come into effect. The present contribution describes how this non-hospital obstetric care has developed in the last 3 years. The medical care situation is explained based on legal conditions. Special attention is paid to regulations concerning quality management as well as the certification or auditing required to remain listed in the national register of midwife-led units at the Social Health Insurance. Results are shown from data collected by the Associa-tion for Quality Assurance on Out-of-hospital births (QUAG) and from a pilot project which also contains comparisons with clinical findings. The discussion refers to data taken from German as well as international publications. The conclusion points out some aspects in need of further development.

Legal status and regulation of complementary and alternative medicine in Europe.

OBJECTIVE: The study aims to review the legal and regulatory status of complementary and alternative medicine (CAM) in the 27 European Union (EU) member states and 12 associated states, and at the EU/European Economic Association (EEA) level. METHODS: Contact was established with national Ministries of Health, Law or Education, members of national and European CAM associations, and CAMbrella partners. A literature search was performed in governmental and scientific/non-scientific websites as well as the EUROPA and EUR-lex websites/ databases to identify documents describing national CAM regulation and official EU law documents. RESULTS: The 39 nations have all structured legislation and regulation differently: 17 have a general CAM legislation, 11 of these have a specific CAM law, and 6 have sections on CAM included in their general healthcare laws. Some countries only regulate specific CAM treatments. CAM medicinal products are subject to the same market authorization procedures as other medicinal products with the possible exception of documentation of efficacy. The directives, regulations and resolutions in the EU that may influence the professional practice of CAM will also affect the conditions under which patients are receiving CAM treatment(s) in Europe. CONCLUSION: There is an extraordinary diversity with regard to the regulation of CAM practice, but not CAM medicinal products. This will influence patients, practitioners and researchers when crossing European borders. Voluntary harmonization is possible within current legislation. Individual states within culturally similar regions should harmonize their CAM legislation and regulation. This can probably safeguard against inadequately justified over- or underregulation at the national level.