Medical Devices Law Research Articles

Ethics, design, and implementation criteria of digital assistive technologies for people with dementia from a multiple stakeholder perspective: a qualitative study

BackgroundDementia impairs the ability of people with dementia to be autonomous and independent. They need support from third parties, who should ideally respect their autonomy and independence as much as possible. Supporting people with dementia can be very burdensome for caregivers and numbers of patients increase while numbers of potential caregivers decline. Digital assistive technologies (DATs) that directly support patients or their caregivers may help bridging the increasing gap between need of support and available resources. DATs have the potential to preserve the autonomy and independence of people with dementia and promote their abilities, if they are properly designed in close interaction with future users. In our study, we focused on ethical concerns, technological requirements, and implementation criteria for DAT in general and specifically to support outdoor mobility of people with dementia.MethodsWe applied a qualitative approach and conducted a World Café (2 tables, n = 7) and an online focus group (n = 6) with people with dementia, relatives, healthcare professionals, scientists, ethics experts, and experts for digitally-assisted medical care. We descriptively analyzed the data using a content analysis approach.ResultsThe participants reported technological (e.g., lack of Wi-Fi), financial (e.g., expensive devices or lack of budget for DATs), political (e.g., legal hurdles such as the European Medical Device Law or data protection regulations) as well as user-related hurdles (e.g., lack of digital competence) for the implementation of DAT in dementia care. Among the issues discussed were the importance of autonomy, independence, safety, privacy, and questions of decision making capacity in DAT’s use. Participants identified opportunities and benefits in self-learning, situation-aware DATs and wished for dementia-friendly communities. They emphasized the value of personal interaction that should not be replaced, but rather supported by DAT.ConclusionThe results revealed multiple hurdles and ethical concerns for DAT use and provided recommendations for designing and implementing DATs. Further investigations are needed on the impact of DAT on personal interactions in caregiving and the role of DAT in dementia-friendly communities.

Considering the Professionalism of Pharmacists from a Viewpoint of "Regulatory Science"

Regulatory science underpins scientific regulations, including reflection papers, guidelines, and administrative notices, and is closely related to the quality assurance (QA) of pharmaceuticals, foods, and chemicals in our living environment. Historically, QA has been considered the basis of pharmaceutical science. Therefore, the Pharmaceutical and Medical Device Law specifies that pharmacists, as marketing directors of pharmaceutical products, are responsible for their QA. Furthermore, a pharmacist is responsible for the QA of foods and environmental chemicals by several laws; for example, as a food sanitation supervisor or an environmental sanitation training officer. This suggests that the professional expertise of pharmacists is expected in medical care where pharmaceuticals are used and in other fields associated with QA. Thus, I consider that the professionalism of a pharmacist is guided by spiritual concepts with a pragmatic attitude and conformance to these expectations.

A Trial of Practical Training on Online Medication Instructions in Clinical Preparatory Education: Development of Human Resources to Provide New Forms of Medical Care after the COVID-19 Pandemic

The coronavirus disease 2019 (COVID-19) pandemic has considerably affected several social services. The Ministry of Health, Labour, and Welfare has partially revised the Pharmaceuticals and Medical Devices Law and established legislations on permanent online medication instructions. Based on these social needs, the development of human resources to provide online medication instructions is vital. Therefore, we developed a training program for providing online medication instructions in preparatory clinical education. Pharmacy students who had conducted medical interviews with standardized patients participated in the training. Educational outcomes were evaluated using an objective multiple-choice test and free description before and after practical training. The median number of correct answers on objective tests on the legislation on online medication instructions increased significantly. Based on the free description analysis, students were able to comprehend the influence of communication environment on the quality of medication instructions. Based on the results of the direct evaluation using objective testing and indirect evaluation by analyzing the free descriptions, they also acquired the skills necessary for providing online medication instructions. Therefore, this training program can contribute to mastering the provision of online medication instructions.

JS-WHL-ISH-LANCET-4: VALIDITY OF AUTOMATED BPMD IN CLINICAL PRACTICE AND PUBLIC HEALTH. A GLOBAL NEED FOR HYPERTENSION MANAGEMENT

HEARTS in the Americas is the flagship program to improve population hypertension control and to reduce the CVD burden. Currently, the initiative is being implemented in 2095 primary health care facilities in 24 countries. Accurate BP measurement is key to effective management of hypertension and is one of the six strategic pillars of HEARTS. A pivotal action to facilitate the progress of the agenda was to examine the regulatory frameworks related to BPMDs in participating countries. Study found that most countries had an existing medical devices law, or the foundation for such a law, that stipulated a regulatory bodies responsibilities. However, only six countries had regulations that applied explicitly to BPMDs, and just two had regulations that mandated accuracy and precision validation criteria as a condition of premarket approval. Seven countries had government bodies responsible for enforcing medical device regulations, and seven had mechanisms to remove devices from the market that did not comply with regulations. Seven countries had a centralized system of acquiring BPMDs, but the acquisition was only regulated in six of these countries. In summary, BPMDs can be approved for sale in most countries without the manufacturer providing evidence of passing an internationally accepted clinical validation standard. The efforts to improve access to validated automated BPMDs are different for each country, in line with its priorities, health system maturity including regulatory, economic, and political conditions. Indeed, most of the facilities implementing HEARTS began to use accuracy-validated automated BPMDs. The general achievements showed in concrete actions are twofold: sectors of governments have been investing politically and administratively in modifications to regulations that do not require a substantive legislative process; and improved procurement toward exclusive access of validated automated BPMDs has been at least partially achieved. The improvement of procurement mechanisms has focused on defining technical specifications that include accuracy validation. The challenges that the countries face to reach the goal of exclusive use of validated BPMDs in PHC are enormous and multifactorial. This confirms the need for a robust regulatory framework and comprehensive strategic approach to exclusive use of clinically validated automated BPMDs at regional level. The successful implementation of the initiative depends on a coordinated effort across government and other stakeholders that will contribute to better diagnosis and management of hypertension in the Americas.

Health and medical apps - Same same but different? A review of definitions in public health and law

Abstract The terms health app and medical app are often used interchangeably but do not necessarily mean the same. Medical apps can be regulated as mobile medical devices and therefore need to meet general safety and performance requirements. On the contrary, health apps are not part of this legal framework and do not need proof of their efficacy or guaranteeing data security. We need distinct definitions of health and medical apps to understand these terms better and regulate such technologies more effectively. We will provide an overview of health and medical apps definitions and a differentiation flowchart from public health and legal perspectives. A search in 6 databases identified 22 publications that defined health apps and 11 reports that described medical apps. The core elements of these definitions were identified through qualitative analysis. Health and medical apps share the same devices, technical functions and collect health data. While it can be highly challenging to decide which legal requirements have to be fulfilled by an app, we deem it unfit as a distinction criterion. It requires legal knowledge, which is neither suitable nor practical for users. However, medical device law is closely linked to the app’s intended medical or health purpose criteria, which allows a clear differentiation. Additionally, the difference in the user group can be used for separation. Our suggestion for the definition would be that health apps are software programs on mobile devices that process health-related data on/for their user. They can be used by every health-conscious person to maintain, improve or manage the health of an individual or the community. As an umbrella term, health apps include medical apps. They share the same technological functions and devices as health apps. Health professionals, patients, and family caregivers are the main user groups of medical apps. Due to the intended use for clinical purposes, medical apps can be regulated as mobile medical devices. Key messages • Separating apps based on legal regulation is impractical & can’t be expected from all stakeholders. Differencing between health and medical apps requires the user group and the health aim of the app. • Health apps include medical apps. Since 2019, medical apps in Germany contain digital health applications (DiGA). Since 2022, medical apps partly include digital care applications (DiPA).

Legal aspects of data cleansing in medical AI

Data quality is of paramount importance for the smooth functioning of modern data-driven AI applications with machine learning as a core technology. This is also true for medical AI, where malfunctions due to "dirty data" can have particularly dramatic harmful implications. Consequently, data cleansing is an important part in improving the usability of (Big) Data for medical AI systems. However, it should not be overlooked that data cleansing can also have negative effects on data quality if not performed carefully. This paper takes an interdisciplinary look at some of the technical and legal challenges of data cleansing against the background of European medical device law, with the key message that technical and legal aspects must always be considered together in such a sensitive context.

The Intention; Requirements for Software as a Medical Device in EU Law

The role of software in society has changed drastically since the start of the 21st century. Software can now partially or fully facilitate anything from diagnosis to treatment of a disease, regardless of whether it is psychological or pathological, with the consequence of software being comparable to any other type of medical equipment. Furthermore, software can be disembodied from the traditional role of medical equipment, which is clearly seen in the use of apps. %Make that clearer We see this with the medical device legislation, specifically the Medical Device Regulation (MDR) not being explicitly created for software, as well as unpredictable developments in the field such as contact tracing applications or self diagnostic tools in general. Any uncertainties concerning the interpretation of these rules must therefore be cleared, both for the sake of the manufacturer as well as the user. In this paper, we show how and when software is considered a medical device in EU law, more specifically in the Medical Device Regulation. To do this, we first create a framework for the intention of the manufacturer, since this would otherwise likely pose a barrier that would prevent software from being seen as a medical device at all. We show how and where software is specifically mentioned in the regulation, and how it is understood. We also include a comparison between US law and the EU regime, and take a quick look at contact tracing applications as such, as well as the practice of two European regulators. We finally create, from existing requirements, a decision diagram comprising a guide to determining whether a piece of software is a medical device or not under the MDR, to illustrate our findings and combine this with with the aforementioned manufacturer's intention framework. We find that in theory it is possible to determine whether software is a medical device, and therefore falls within the MDR's scope or not, but this assessment remains very unsure. This is because of the ambiguity of the criteria as well as how the MDR is designed. A literal interpretation of the Regulation yields immediate issues with whether a particular piece of software should be included or not. Furthermore, if software is considered to be a medical device, the software's manufacturer will be subject to strict organisational and cybersecurity obligations, and can face severe penalties such as withdrawal or bans on their software for infractions. At the same time, enforcement is left to national regulators in each Member State, creating potential inconsistencies in oversight and interpretations, as well as lacking a clear body of legal practice. We see that because of the pivotal importance of manufacturer's intention for triggering the application of the MDR, there exists an actual risk of circumvention of the MDR, and show that the Principle of Circumvention could be applied. However, we find that US law, via FDA guidelines, has measures that can be used as inspiration for reform of medical device law and practice in the EU, including an exclusion list and overarching federal penalties in the form of withdrawal, for not reporting which and how one's software is a medical device.

Practical blood transfusion and adverse transfusion reactions

Blood transfusion, which has been conducted as a basic medical procedure since 17th century, is a supportive therapy to compensate loss of each blood component. All blood materials are donated, and alive and subject to decay, type-dependent for transfusion, vary in quality, may induce severe adverse reactions, such as anaphylaxis, and may transmit infectious agents. Therefore, not only the scientific and clinical decisions but also ethical considerations should be focused on for their use. All blood products are determined as "Products Derived from Specific Organism" by the Pharmaceutical and Medical Devices Law in Japan. Of note, blood management systems are different among countries; the Japanese Red Cross Society is a unique organization that collects and manufactures blood products under supervision of the Japanese Government. It establishes a hemovigilant system by which it collects all the information concerning transfusion-related adverse events and provides them to the responsible transfusion service staff of each hospital. Physicians should check all the information from the Japanese Red Cross and refer both the "Guidelines for Blood Transfusion" and "Guidelines for the Usage of Blood Products" by the Ministry of Health, Labor and Welfare for transfusion practice.

Artificial intelligence : Ahelpful tool for radiologists?

Artificial intelligence (AI) is not intelligent in the human meaning-AI works on the basis of algorithms created by humans and the results of AI are based on real-world data. AI is regulated by all legal frameworks that also apply in other scenarios, in particular data protection law and medical device law. AI delivers results that are as good as the database that formed the learning content of the AI enables. If, for example, the data on which the AI is based contain discrimination, this discrimination is "learned" by the AI; since the AI does not really think, the AI cannot reflect its own results either-it can only make acomparison within the parameters of the specifications by the software developers. If AI is used, the question of the algorithms implemented and the database on which the decision is based must therefore be clarified beforehand and acheck must be carried out based on this to determine whether the AI is suitable for use. Due to the missing possibility of real human thinking, AI cannot replace physicians, but can assist them in their daily work.

Regulating Certification Bodies in the Field of Medical Devices: The PIP Breast Implants Litigation and Beyond

This article uses the breast implants scandal around the French producer Poly Implant Prothèse (PIP) to discuss the regulation of medical devices in EU law. Thereby, the specific focus is on the role of tort liability of certification bodies in complementing the public law regime of medical devices law. As tort law has not been harmonized yet at the level of EU law, national legal systems may produce different results; which indeed the PIP case demonstrates, with diverging judgments from French and German courts. Showing the deficiencies of the public law system of the Medical Devices Directive of 1993 as well as of the new Medical Devices Regulation of 2017, the article argues that tort liability is a necessary regulatory instrument to ensure that certification bodies live up to their duties under medical devices law and therefore a necessary instrument for the protection of the health and safety of patients.

Legal framework for E‑health products on the European market

Legitimately categorizing software in the healthcare sector is complex. According to European medical devices law, software can be considered amedical device. The decisive factor is whether the software is used for directly controlling atherapeutic 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. Acontribution 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.

PP53 New Medical Device Law: Germany's Experience With Refund Restrictions

Introduction:Since 2005, new hospital examination and treatment methods (NUB) were reimbursed by hospital individual supplementary fees as long as they were not sufficiently covered by a DRG. In 2016, the NUB procedure was decisively changed by legal norm §137 h SGB.V to evaluate medical devices (MD) of high risk classes, particularly invasive, or new theoretical-scientific concepts versus treatment alternatives by the Federal Joint Committee (G-BA). Hospitals and manufacturers have to submit detailed information on the application of the MD and the scientific evidence to G-BA along with a NUB application. This assessment may lead to exclusion of the method from reimbursement by the statutory health insurance (SHI).Methods:The published MD consultation submissions, assessments and G-BA resolutions (to date) were analyzed regarding evaluation criteria, treatment potential and study obligation.Results:In 2017, nineteen procedures were reviewed by G-BA with respect to §137 h. Two ultra-controlled high-intensity focused ultrasound (HIFU) indications were regarded as having potential benefit but not sufficient evidence yet, thus respective studies have to be initiated. Three procedures were regarded as eligible according to §137 h but not yet evaluated. Six procedures (ultra-controlled HIFU in five indications, targeted lung denervation in chronic obstructive pulmonary disease) were rated as having no potential benefit, while eight procedures were regarded as not eligible according to §137 h.Conclusions:Initially put into place for high risk class and primarily invasive devices, consultations and assessments under §137 h show that there is some uncertainty around applicability criteria. The majority of those procedures which fell under the assessment law failed to be granted potential benefit as treatment alternative. Currently consultations are ongoing which could possibly lead to the exclusion of these methods from the performance spectrum of the SHI. Manufacturers should revise their study concepts in order to fulfill the specific demand for robust evidence.

New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products

In Japan, the Pharmaceuticals and Medical Devices Law was passed in 2014. In this new law, regenerative medical products were defined, and a conditional and term-limited approval system only for regenerative medical products was instituted. Therefore, regenerative medical products can be approved based on phase I and/or II trials. Gene therapy and adoptive cellular therapy are categorized as regenerative medical products. This law is intended for registration trials for marketing authorization. The Act on the Safety of Regenerative Medicine was also implemented in 2014. This act is intended for clinical research and medical practice involving processed cells other than registration trials. Under this act, a review of plans on medical treatments or clinical studies by a certified committee and submission of the plans to the Ministry of Health, Labour and Welfare (MHLW) are mandatory. The MHLW instituted the SAKIGAKE (meaning a pioneer or forerunner in Japanese) designation system in 2015. This designation is similar to the breakthrough therapy designation in the US and PRIME in the EU. In addition, the MHLW started the "Project for Enhanced Practical Application of Innovative Drugs, Medical Devices and Regenerative Medical Products" to promote personnel exchange and cooperation in writing of guidelines on the evaluation of innovative medical products between the Pharmaceuticals and Medical Devices Agency and academia. Some new guidelines regarding gene and cellular therapy were published. In this review, we comprehensively described these complicated regulations and problems to be solved in order to facilitate global readers' understanding of Japanese regulatory frameworks.

Osteoporosis Liaison Service and Medication Instruction.

The goals of the osteoporosis liaison service are to prevent the disease more effectively, to diagnose it properly and to provide a higher quality treatment for it as well as to increase healthy life- span and to minimize the gap in health status by offering raising awareness activities. Pharmacist can play an important role in achieving both of goals. "The family pharmacist system", which was introduced by the Pharmaceuticals and Medical Devices Law(Yakkiho)in 2016, is expected to contribute to achieve the former goal while "Health supporting pharmacy" is expected to strive for the latter goal. It is also necessary to build a patient-centered collaborative relationship between hospital pharmacists and those of insurance pharmacy by sharing the information on the patients' medication. In that sense, it seems that osteoporosis managers who have a license for a pharmacist can play a significant role as a collaboration hub in the service and they can be expected to help prevent osteoporosis bone fracture and repeated fracture by supporting them in life in the community. It seems their role as a connector among all pharmacists will be more important.

New Health Technology Assessment for Market Access of Medical Device in Korea: Review of Medical Law, Medical Device Law, National Health Insurance Law

New Health Technology Assessment for Market Access of Medical Device in Korea: Review of Medical Law, Medical Device Law, National Health Insurance Law

Medical Devices Law for anesthesiologists

The Medical Devices Law is a relatively new legal system, which has replaced the still well-known medical devices regulations in Germany. The Medical Devices Law in Germany is based on European directives, which have been translated into national law with the Medical Devices Act. The Medical Devices Act is a framework of regulations and incorporates a number of decrees that address specific topics within the medical devices directives and in turn individual regulations refer to guidelines and recommendations from other sources which provide detailed technical information on specific topics. Overall, the Medical Devices Act represents a very complex legal system, which needs to be permanently observed with respect to continuous updating and adjustment. In this article the design and the structure are described but most of all the article filters significant problem areas that need to be considered when using and operating medical devices, especially for anesthesiologists.

Was muss ein Chirurg von der Arbeit einer medizinischen Ethik-Kommission wissen?

Ethical committees or institutional review boards are interdisciplinary committees to assess the ethical, social, legal and medical aspects of research involving human subjects. The ethics commission is to protect both the patient as well as the investigators and other personnel involved in the implementation of scientific projects. According to the professional code (Berufsordnung) every physician is obliged to consult an ethics committee to get a an approval before carrying out a research project. Concerning the Declaration of Helsinki, the advice of physicians is an international standard before carrying out a research project. In addition to the advisory function the ethics committee has an authorisation function within the pharmaceutical and medical device law. In the present publication the advisory and authorisation functions of an German ethics committee are briefly explained.

Die Nutzenbewertung von Medizinprodukten in der chirurgischen, patientenorientierten Forschung

Surgery depends on the application of therapeutic procedures that are based on scientific evidence. It legitimises its claim in patient care through operations with proven benefit consisting of cure or improvement of symptoms. Moreover, clinical research and evaluation of surgical technique, strategy and innovation is closely entangled with medical devices. These surgical trials are regulated beyond the German drug and medical devices law, but scientific and ethical rules still follow the principles of clinical epidemiology and evidence-based medicine. Standardisation of surgical and perioperative care is the inevitable prerequisite in clinical trials to define and to evaluate effectiveness of surgical devices. The Study Centre of the German Surgical Society has established an efficient infrastructure for such trials in Germany and is working to refine the scientific methodology in order to improve the current basis of evidence. (As supplied by publisher).

Are the Votes of Ethics Committees in Germany for the Protection of Clinical Study Trial Subjects “Sovereign Acts?”

A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called "revaluation" of the Medical Device Law Deutsches Medizinproduktegesetz-MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the medical faculties and are therefore official authorities. It follows that the votes of ethics committees are then "sovereign acts" or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee's vote is a sovereign act. This has, in turn, resulted in the public ethics committees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethics committees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult.

Realization of administration unit for 3He with gas recycling

Hyperpolarized (HP) noble gases (3He,129Xe) are used for MR-imaging of the lung. In the majority of case the HP gas is filled in Tedlarbags and directly inhaled by the patients. Starting from an earlier pilot device, an administration unit was built respectively to the Medical Devices Law to administer patients HP noble gas boli in defined quantities and at a predefined time during inspiration with high reproducibility and reliability without reducing MR-quality. The patient's airflows are monitored and recorded. It is possible to use gas admixtures, measure the polarization on-line and collect the exhaled gas for later recycling. The first images with healthy volunteers were taken with this setup in a clinical study. Current results will be presented.