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

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 e‑prescription, 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