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Digital health technology (DHT) is increasingly used to facilitate the conduct of clinical drug trials. The European regulatory environment would benefit from some adjustments to realize the full potential of DHTs. Considering current discussions such as the European Accelerating Clinical Trial Initiative (ACT EU), we propose four concrete adjustments to this regulatory landscape to introduce risk-based qualification approaches for DHTs. In our view, these changes would have the potential to facilitate the use of DHT in clinical research and thus provide access to innovative therapies in Europe., (© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Public Health Emergencies (PHE) have had repercussions on health systems on a global scale, and timely access to new health technologies is a challenge for health policy. The national regulatory authorities (NRA) play a key role in the evaluation and regulation of these technologies. The present study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the health system's effective response during a PHE. This research, based on WHO and Brazilian NRA norms and documents, considered dimensions related to strategies for strengthening regulatory activities and regulatory instruments used to accelerate access to technologies, especially during PHEs. International cooperation between the NRA and the WHO were important strategies for strengthening the NRA, with emphasis on the use of reliance, regionalization, accelerated assessments, and work/information sharing, as well as the processes of regulatory harmonization and convergence. In addition to the use of existing regulatory instruments, efforts were also identified in order to implement new ones.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues., (© The Author(s) 2024. Published by Oxford University Press.)

Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and outcomes. As the regulatory contours of these technologies are being defined, there is a notable lack of literature on the key stakeholders such as the organizations and interest groups that have a significant input in shaping the regulatory framework. This article explores the perspectives and contributions of these stakeholders in shaping the regulatory paradigm of AI-enabled medical technologies. The formation of an AI regulatory framework requires the convergence of ethical, regulatory, technical, societal, and practical considerations. These multiple perspectives contribute to the various dimensions of an evolving regulatory paradigm. From the global governance guidelines set by the World Health Organization (WHO) to national regulations, the article sheds light not just on these multiple perspectives but also on their interconnectedness in shaping the regulatory landscape of AI., (© 2024. The Author(s).)

Argentina, as other countries, showed several public policies related to the health technologies implemented to fight and treat the COVID-19 pandemic. This study sought to analyze how articulation vs. cooperation and autonomy vs. division of powers between entities occurred in Argentina, exploring asymmetries between several entities in implementing public policies related to health technologies during the pandemic and the influences of other actors. For this, a documentary research was carried out related to 2020-2021 (technical reports published by the World Health Organization, national agencies and scientific societies, laws, court decisions, press, and research and in-depth interviews with members of the Argentine Ministries of Health). The processes and results of decision-making in the Ministries of Health were analyzed, outlining the coverage and orientations of each technology and the political party in power in the province. This study found heterogeneous results and processes between Ministries and disputes within them. It also observed the poor adherence to official guidelines due to technical-political criteria (power relations, social, media, academic, judiciary, and legislative pressure). Some cases showed a strong tension between the government and its opposition over the discussion of technologies. Each province in Argentina has autonomously defined its policies on health technologies for COVID-19, and decision-making in public administration was disorderly, complex, and non-linear during the pandemic.

Background: Patenting protects innovation, fosters academic incentives, promotes competition, and generates new revenue for clinician-inventors and their institutions. Despite these benefits, and despite plastic surgery's history of innovation, plastic surgery-related patent applications are few. The goal of this article was to use unpublished data and formulate a robust discussion., Methods: The U.S. Patent and Trademark Office's boolean search was investigated between the timeline of 1975 and June 23, 2020, to identify patents related to the key phrases to contrast patent (both, issued and filed) tally in each specialty. Queries for two key phrases related to plastic surgery and a core plastic surgical activity, both with and without the added term "plastic surgery," were performed., Results: Total patents with "cardiology" outnumber those with "plastic surgery" by 22,450 versus 7749 (i.e., almost 3:1). The overwhelming number of patents with "cosmetic" are non-plastic-surgery related: 87,910 total versus 2782 for those with plastic surgery. The corresponding numbers for "wound healing" are 36,359 versus 2703. Reasons for the patent gap between clinical innovations in plastic surgery and number of patents in our field are identified. Clear steps to bridge this gap are delineated that include a step-by-step process for patenting, from idea creation through commercialization. The authors propose "breakthrough to bank," a framework wherein academic medical centers can create an environment of innovative freedom, establish the infrastructure for technological transfer of intellectual property, and generate a pipeline toward commercial applications., Conclusions: Innovation and inventions are important hallmarks for the progress of plastic surgery. Using a stepwise process, it may be possible to convert ideas into patents., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Medical interventions are becoming more complex day by day. Moreover, compared with the past, more healthcare professionals take part in the same intervention in the field of medicine. The use of technology in medical interventions has also increased. This change in the health sector brings together several legal discussions. In this study, the legal consequences that arise from the treatment processes carried out by the residents and resident educators (registerers / attending physicians), the exchange of information between them, and the usage of some messaging platforms, especially WhatsApp, in this process will be analyzed.

Since hydrogel therapies have been introduced into clinic treatment procedures, the biomedical industry has to face the technology transfer and the scale-up of the processes. This will be key in the roadmap of the new technology implementation. Transfer technology and scale-up are already known for some applications but other applications, such as 3D printing, are still challenging. Decellularized tissues offer a lot of advantages when compared to other natural gels, for example they display enhanced biological properties, due to their ability to preserve natural molecules. For this reason, even though their use as a source for bioinks represents a challenge for the scale-up process, it is very important to consider the advantages that originate with overcoming this challenge. Therefore, many aspects that influence the scaling of the industrial process should be considered, like the addition of drugs or cells to the hydrogel, also, the gelling process is important to determine the chemical and physical parameters that must be controlled in order to guarantee a successful process. Legal aspects are also crucial when carrying out the scale-up of the process since they determine the industrial implementation success from the regulatory point of view. In this context, the new law Regulation (EU) 2017/745 on biomedical devices will be considered. This review summarizes the different aspects, including the legal ones, that should be considered when scaling up hydrogels of natural origin, in order to balance these different aspects and to optimize the costs in terms of raw materials and engine.

Personalised medicine, digital innovations, and neuro-technologies all offer significant potential benefit for human health and welfare, but also raise complex governance challenges. A variety of approaches have been adopted in the governance of innovative medicines and health technologies, including risk assessment, ethics and self-governance. Recently anticipatory or 'upstream' modes of governance have garnered favour. Anticipatory regulation demands a closer relationship between regulators and innovators, to shape the trajectories of the technology. In the EU context, responsible research and innovation has emerged as a key mechanism of governance. This is linked but distinct from a human rights governance which has the advantage of exerting both legal and moral force. What is needed in the healthcare context are governance models which ensure human rights considerations are taken into account from the earliest stages of innovation, to maximise the likelihood that developments are from the outset beneficial and oriented towards protecting ethical values.

Patent rights are recognized as a property asset with an attendant right to exclude. However, recent policy developments highlight that the right to exclude is not inviolable. This paper explores two rapidly evolving exceptions to patent exclusivity, both of which take the form of compulsory licenses. First, under the international Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS"), national governments can compel patent owners to out-license technology in service of greater good. These egalitarian compulsory licenses improve access to technology but undermine patent value. Second, compulsory licenses are increasingly relied upon as an equitable remedy in U.S. patent litigation. Typically referred to as "ongoing royalties," these court-mandated compulsory licenses are a modern alternative to injunctions against adjudged infringers. TRIPS compulsory licenses and ongoing royalties arise under independent legal frameworks, but necessarily invoke parallel economic considerations. While the wisdom of each has been discussed at length by others, this paper explores principles of royalty determination employed in each context. Considering both frameworks, an analysis of where each succeeds and fails is provided, together with an exploration of optimized royalty frameworks.

Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness of the current Guideline for Stem Cell Research and Therapy (2009) are examined. The study's findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation (2016) of the International Society for Stem Cell Research (ISSCR) containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders.

The question of early patient access to innovative health technologies arises from the assumption that, once a certain level of effectiveness or efficiency is achieved, waiting for mainstream coverage would represent a loss of opportunity for patients or for the community. This was the premise on which the round table based its dialogue. Early access is understood as the funding of a technology that comes within this field and is CE-marked but has not yet attained "mainstream" coverage. There are several early access schemes in France ("forfait innovation", early coverage, exceptional coverage, RIHN). This round table was an opportunity to establish mapping, extended to devices not dedicated to early access but which could nevertheless provide some patients with access to non-mainstreamed technologies (Article 51, ETAPES experiments, DGOS call for projects, local schemes). It is an initial step that would need to be further developed and complemented by the dissemination of common communication materials available to all, including patients. The existing schemes are in fact still poorly known. Consideration would also have to be given to the advisability of developing these schemes in order to adapt them to the new European requirements. More generally, early access schemes must be integrated into an ecosystem that is conducive for their relevance: consideration of procedures associated with medical devices benefiting from early access; short time frames of examination; patient information. Finally, the round table proposes the creation of a new early access scheme, complementary to those that exist and that would be positioned, after CE marking, between the "forfait innovation" and mainstreaming: PRESTO (Prise En charge Sécurisée et Temporaire de technologies innOvantes) (secure and temporary coverage for innovative technologies)., (Copyright © 2019. Published by Elsevier Masson SAS.)

Dermatologists are among the most inventive physicians, trained in the multiple disciplines of medical dermatology, surgical dermatology, and dermatopathology. Many of the advances in dermatology practice have been derived from inventive colleagues who identify opportunities for improvement in practice, develop viable prototypes to address these practice opportunities, and persevere through the hard work of developing new technologies to advance the practice of dermatology. In this article, we will review the basic elements of invention, patents, and the range of outcomes associated with the pursuit of invention. Examples of innovative dermatologic technologies and approaches will be reviewed. Opportunities abound for dermatologists to contribute to the advancement of medical care through invention in our specialty. J Drugs Dermatol. 2019;18(9):904-908.

In 2016, the European Medicines Agency published the conclusions of its pilot on adaptive pathways, with products in early stages of development still building up to their marketing authorisation. Adaptive pathways rests on three principles: iterative development; gathering evidence through real-life use to supplement clinical trial data; and early engagement of patients, payers and health technology assessment bodies in discussions on a medicine's development. While the pilot has now finished, the practical system-wide implications of employing the adaptive pathways approach are not known and further consideration of these three principles is required. In this paper we used the three principles that underpin adaptive pathways to discuss main scientific and European policy developments likely to determine progress on further implementing adaptive pathways in the European setting., (© 2019 The British Pharmacological Society.)

Purpose of Review: Advancements in biomedical engineering and advanced therapies including tissue engineering products necessitate revisions to the regulation and governance of their production and use to ensure patient safety. In this review, the current regulations and recent improvements on the governance of biomedical devices are reviewed., Recent Findings: Current regulations on approval of biomedical devices failed to address some important aspects related to the definition of biocompatibility of medical implants. The main issue was that the failure to establish design requirements for a specific application - in this case, the pelvic floor. Another issue was the lack of knowledge on disease mechanisms leading to an inability to define clear targets for surgical treatment. A clear example of this is the recent vaginal mesh scandal., Summary: Surgical innovations are inherently challenging. It is no surprise that the regulatory landscape lags behind advancements in biomedical technologies. Very recent modifications to the available regulations particularly in Europe aim to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures patient safety while supporting innovation.

Wearable medical devices (WMDs) will advance point-of-care diagnostics and therapeutics. This article analyses the market and patents for wearable devices. Activity monitors have the largest market share, and the intellectual property landscape is dominated by electronics corporations. However, the majority of these patents have not been realized in commercial products., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objectives: Health care innovation and technologies can improve patient outcomes, but policies and regulations established to protect the public interest may become barriers to improvement of health care delivery. We conducted a scoping review to identify policy and regulatory barriers to, and facilitators of, successful innovation and adoption of health technologies (excluding pharmaceutical and information technologies) in Canada., Methods: The review followed Arksey and O'Malley's methodology to assess the breadth and depth of literature on this topic and drew upon published and grey literature from 2000-2016. Four reviewers independently screened citations for inclusion., Results: Sixty- seven full- text documents were extracted to collect facilitators and barriers to health technology innovation and adoption. The extraction table was themed using content analysis, and reanalyzed, resulting in facilitators and barriers under six broad themes: development, assessment, implementation, Canadian policy context, partnerships and resources., Conclusion: This scoping review identified current barriers and highlights numerous facilitators to create a responsive regulatory and policy environment that encourages and supports effective co-creation of innovations to optimize patient and economic outcomes while emphasizing the importance of sustainability of health technologies., (Copyright © 2018 The Author(s). Published by Elsevier B.V. All rights reserved.)

Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".

Knee replacement surgery is one of the most commonly done and cost-effective musculoskeletal surgical procedures. The numbers of cases done continue to grow worldwide, with substantial variation in utilisation rates across regions and countries. The main indication for surgery remains painful knee osteoarthritis with reduced function and quality of life. The threshold for intervention is not well defined, and is influenced by many factors including patient and surgeon preference. Most patients have a very good clinical outcome after knee replacement, but multiple studies have reported that 20% or more of patients do not. So despite excellent long-term survivorship, more work is required to enhance this procedure and development is rightly focused on increasing the proportion of patients who have successful pain relief after surgery. Changing implant design has historically been a target for improving outcome, but there is greater recognition that improvements can be achieved by better implantation methods, avoiding complications, and improving perioperative care for patients, such as enhanced recovery programmes. New technologies are likely to advance future knee replacement care further, but their introduction must be regulated and monitored with greater rigour to ensure patient safety., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

In this article, I draw on research carried out in Europe, primarily in Germany, on patients' and scientists' perspectives on mitochondrial replacement techniques (MRTs) in order to explore some of the complexities related to collective representation in health governance, which includes the translation of emerging technologies into clinical use. Focusing on observations, document analyses, and interviews with eight mitochondrial disease patient organization leaders, this contribution extends our understanding of the logic and meanings behind the ways in which patient participation and collective representation in health governance initiatives take shape. My findings highlight the ways in which a commitment to a global mitochondrial disease patient community and a sense of patient solidarity influence expressions of support with regard to legalizing mitochondrial replacement techniques. My analyses illustrate how normative practices and expectations of participatory governance potentially foreclose opportunities for sustained collective patient engagement with the complex ethical, social, and political dimensions of emerging technologies and may silence diverse and potentially dissenting embodied and lived responses to the prospects of particular technological developments.

Recent advances in military-funded neurotechnology and novel opportunities for misusing neurodevices show that the problem of dual use is inherent to neuroscience. This paper discusses how the neuroscience community should respond to these dilemmas and delineates a neuroscience-specific biosecurity framework. This neurosecurity framework involves calibrated regulation, (neuro)ethical guidelines, and awareness-raising activities within the scientific community., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies., Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec's (Canada) publicly funded healthcare system., Results: Entrepreneurs have a direct influence over a new technology's value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology-as a health intervention and as an economic commodity-and provide economic worth to the venture that is bringing the technology to market., Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy., (© 2017 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Objective: To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China., Methods: Exploratory factor analysis (EFA) and first-order confirmatory factor analysis (CFA) based on a structure equation model (SEM), higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre l5.3., Results: There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation., Conclusion: This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.

The study aimed to examine the regulation and adoption of health technologies for the diseases of poverty in the Brazil's Unified Health System (SUS). An exploratory, descriptive study was conducted between January and May 2016 consisting of the search and analysis of relevant documents on the websites of Brazil's National Health Surveillance Agency, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Commission for the Adoption of Technologies by the SUS, and Saúde Legis (the Ministry of Health's Legislation System). The 2014 version of the Brazilian National List of Essential Medicines (RENAME, acronym in Portuguese) contained 132 medicines for diseases of poverty. Over one-third of these (49) had only one national producer, while 24 were not registered in the country. The number of medicines contained in the RENAME dedicated to this group of diseases increased by 46% between 2006 and 2014. Despite advances in the regulation and incorporation of technologies by the SUS, given the lack of market interest and neglect of diseases of poverty, the government has a vital role to play in ensuring access to the best available therapies in order to reduce health inequalities. It therefore follows that Brazil needs to improve the regulation of medicines that do not attract market interest.

This review focuses only on specific studies into the SUS regionalization process, which were based on empirical results and published since 2006, when the SUS was already under the aegis of the Pact for Health framework. It was found that the regionalization process is now underway in all spheres of government, subject to a set of challenges common to the different realities of the country. These include, primarily, that committee-structured entities are valued as spaces for innovation, yet also strive to overcome the bureaucratic and clientelist political culture. Regional governance is further hampered by the fragmentation of the system and, in particular, by the historical deficiency in planning, from the local level to the strategic policies for technology incorporation. The analyses enabled the identification of a culture of broad privilege for political negotiation, to the detriment of planning, as one of the main factors responsible for a vicious circle that sustains technical deficiency in management.

Research in neuroscience and neurotechnology (neuroS/T) is progressing at a rapid pace with translational applications both in medicine, and more widely in the social milieu. Current and projected neuroS/T research and its applications evoke a number of neuroethicolegal and social issues (NELSI). This paper defines inherent and derivative NELSI of current and near-term neuroS/T development and engagement, and provides an overview of our group's ongoing work to develop a systematized approach to their address. Our proposed operational neuroethical risk assessment and mitigation paradigm (ONRAMP) is presented, which entails querying, framing, and modeling patterns and trajectories of neuroS/T research and translational uses, and the NELSI generated by such advancements and their applications. Extant ethical methods are addressed, with suggestion toward possible revision or re-formulation to meet the needs and exigencies fostered by neuroS/T and resultant NELSI in multi-cultural contexts. The relevance and importance of multi-disciplinary expertise in focusing upon NELSI is discussed, and the need for neuroethics education toward cultivating such a cadre of expertise is emphasized., (Copyright © 2016 Elsevier Inc. All rights reserved.)

One of the key advantages of adaptive licensing (AL) is to align the licensing of new medicines more closely with patient needs for earlier access to beneficial treatments. From an innovators perspective, "earlier" market access may seem an obvious incentive to gain earlier revenue generation. However, this is offset with an "earlier" start to patent and regulatory protection periods, which, depending on the technology, disease, population, and timing of subsequent asset protection periods, can present a conflict., (© 2016 American Society for Clinical Pharmacology and Therapeutics.)