Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation.

OBJECTIVES: Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for "prescribable" health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. METHODS: We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. RESULTS: When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. CONCLUSIONS: Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Advancing digital health applications: priorities for innovation in real-world evidence generation.

In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.

[Digitalization of healthcare and its effects on quality of care]. / Digitalisierung im Gesundheitswesen und ihre Effekte auf die Qualität der Gesundheitsversorgung.

Ensuring the quality of healthcare services is a core concern of the statutory health insurance system. It is therefore not surprising that recent initiatives to (further) digitalize the healthcare system, specifically to introduce the electronic patient record and other applications in the telematics infrastructure, with the Patient Data Protection Act ("Patientendaten-Schutz-Gesetz", PDSG) of digital health applications with the Digital Care Act ("Digitale-Versorgung-Gesetz", DVG), or to strengthen hospital IT with the Hospital Future Act ("Krankenhauszukunftsgesetz", KHZG), are justified by ensuring or even increasing the quality-of-service provision.This article sheds light on the question of how the use of various digital solutions relates to the classic goals of quality assurance in healthcare, in particular, whether digital solutions are suitable for promoting quality assurance.It is shown that digital solutions are fundamentally suitable for ensuring quality. This is due to two characteristics of digital solutions: the possibility of comprehensive data collection and the possibility of making data available independent of time and place. However, it is also apparent that the benefits associated with digital solutions are highly dependent on the specific use cases.

[Digitized healthcare in 2030-a possible scenario]. / Digitalisierte Gesundheitsversorgung im Jahr 2030 ­ ein mögliches Szenario.

Due to the rapidly advancing digitalization, healthcare will also change significantly in the next few years. For example, in Germany, new legal framework conditions have already set the course for the electronic patient record (ePA), the e­prescription, and the integration of digital health applications (DiGA). The new fast-track procedure of the Federal Institute for Drugs and Medical Devices (BfArM) for evaluating the reimbursability of DiGA is an important step that will be followed by others in the coming years.This article uses a future scenario for the year 2030 to describe the legal, technical, and practical changes that could occur by then. In 2030, healthcare could be organized in individual and integrated treatment pathways that offer comprehensive support to the insured. Interoperable digital components could, for example, make structured data available for research purposes. Doubts concerning data protection could become a thing of the past if data protection law is reformed and harmonized and new consent procedures for patients are developed. New professional fields could become established and market access for innovative digital medical products could be further improved.Another important aspect that can help to exploit the potential of digital healthcare is the creation of a European data space based on a technical infrastructure that upholds high ethical and social standards. Active measures on the part of legislators can create the necessary conditions for innovations to be incorporated into the system for the benefit of patients and for the German healthcare system to be able to cope with the ongoing changes in medical technology.

Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring.

In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern market access are often evolving slowly, sometimes creating market barriers. This article gives a brief overview of the existing clinical studies regarding the use of smart wearables in cardiac monitoring and provides insight into the main regulatory and legal aspects that need to be considered when such products are intended to be used in a health care setting. Based on this brief overview, the article elaborates on the specific requirements in the main areas of authorization/certification and reimbursement/compensation, as well as data protection and data security. Three case studies are presented as examples of specific market access procedures: the USA, Germany, and Belgium. This article concludes that, despite the differences in specific requirements, market access pathways in most countries are characterized by a number of similarities, which should be considered early on in product development. The article also elaborates on how regulatory and legal requirements are currently being adapted for digitally driven wearables and proposes an ongoing evolution of these requirements to facilitate market access for beneficial medical technology in the future.

International comparison of minimum volume standards for hospitals.

INTRODUCTION: Minimum volume standards have been implemented in various countries for quality or safety policies. We present minimum volume standards in an international comparison, focusing on regulatory approaches, selected sets of procedures and thresholds as well as predetermined consequences of non-compliance. MATERIALS AND METHODS: We combined a comprehensive literature search in electronic databases in March 2016 with a hand-search of governmental and related organisations' webpages. We also contacted international experts to verify the information we found in the literature and to obtain additional data. RESULTS: Minimum volume standards have been introduced in different countries predominantly for highly specialized surgical procedures. The same evidence has led to different definitions and ways of implementation of minimum volume standards in Germany, Canada (Ontario), the Netherlands, Switzerland, and Austria. The regulatory approaches to minimum volume standards and the predetermined consequences of non-compliance differ across the countries. CONCLUSION: The sets of procedures for which minimum volume standards and corresponding thresholds have been introduced vary across countries, possibly due to different regulatory approaches. In addition, key attributes of the health care system might affect the development and implementation of minimum volume standards. Therefore, it is not feasible to formulate uniform recommendations that are applicable to all countries. Our results provide a comprehensive overview of international minimum volume standards and can be used to inform policy decisions.

COMPREHENSIVE ASSESSMENT OF COMPLEX TECHNOLOGIES: INTEGRATING VARIOUS ASPECTS IN HEALTH TECHNOLOGY ASSESSMENT.

OBJECTIVES: Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects. METHODS: Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers. RESULTS: The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods' applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources. CONCLUSIONS: The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.