FDA Regulation and Approval of Medical Devices: 1976-2020.

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

A proposal for shoring up Federal Trade Commission protections for electronic health record-connected consumer apps under 21st Century Cures.

Under the 21st Century Cures Act and the Office of the National Coordinator for Health Information Technology (ONC) rule implementing its interoperability provisions, a patient's rights to easily request and obtain digital access to portions of their medical records are now supported by both technology and policy. Data, once directed by a patient to leave a Health Insurance Portability and Accountability Act-covered health entity and enter a consumer app, will usually fall under Federal Trade Commission oversight. Because the statutory authority of the ONC does not extend to health data protection, there is not yet regulation to specifically address privacy protections for consumer apps. A technologically feasible workflow that could be widely adopted and permissible under ONC's rule, involves using the SMART on FHIR OAuth authorization routine to present standardized information about app behavior. This approach would not bias the patient in a way that triggers penalties under information blocking provisions of the rule.

Addressing health disparities in the Food and Drug Administration's artificial intelligence and machine learning regulatory framework.

The exponential growth of health data from devices, health applications, and electronic health records coupled with the development of data analysis tools such as machine learning offer opportunities to leverage these data to mitigate health disparities. However, these tools have also been shown to exacerbate inequities faced by marginalized groups. Focusing on health disparities should be part of good machine learning practice and regulatory oversight of software as medical devices. Using the Food and Drug Administration (FDA)'s proposed framework for regulating machine learning tools in medicine, I show that addressing health disparities during the premarket and postmarket stages of review can help anticipate and mitigate group harms.

When Does Stand-Alone Software Qualify as a Medical Device in the European Union?-The Cjeu's Decision in Snitem and What it Implies for the Next Generation of Medical Devices.

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable European Union (EU) regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU, it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates, but it also signifies a paradigm shift with a rapidly increasing digitalisation of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical artificial intelligence (AI) and Big Data.

The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?

The individual right of access to one's own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA's right of access to one's own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals' ability to find out how much data is being stored and how it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA's investigational device exemption requirements.

How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles - the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA - effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Os desafios do RGPD perante as novas tecnologias blockchain / Los desafíos del RGPD ante las nuevas tecnologías blockchain / The challenges of RGPD in face of blockchain technology / Els desafiaments del RGPD davant les noves tecnologies blockchain

O surgimento de novos softwares baseados em tecnologia blockchain lançam novas perguntas ao novo RGPD, criticado por ter sido criado tendo apenas em vista realidades virtuais centralizadas de controlo de dados. Apesar de quer o RGPD, quer o blockchaindesejarem objetivos comuns, como o aumento da transparência e da confiança na troca de dados online, a verdade é que em vários aspetos os desentendimentos entre ambos são reais: certas noções, como a de responsável pelo tratamento ou subcontratante, dificilmente se adequam; certos direitos, como o direito ao esquecimento ou à transferência de dados, correm o risco de perder conteúdo útil; ou mesmo certos princípios, como o da limitação de tratamento, dificilmente se compatibilizam com esta nova tecnología

La creación y el surgimiento de nuevos programas informáticos basados en la tecnología blockchain desafían el reciente GDPR con nuevas cuestiones, ya que se le critica tener en cuenta sólo las realidades virtuales basadas en el control centralizado de datos. A pesar de que tanto el RGDP como la blockchain comparten intereses comunes para aumentar la transparencia y la confianza en el intercambio de datos en línea, lo cierto es que, en varios aspectos, los malentendidos entre ambos son reales: algunas nociones como la de controlador o procesador de datos, son poco adecuadas; ciertos derechos, como el derecho al olvido o el derecho a la portabilidad de los datos corren el riesgo de perder su aplicación; o incluso ciertos principios, como la minimización de datos, son difícilmente compatibles con esta nueva tecnología

The creation and emergence of new software based on blockchain technology challenge the recent GDPR to new questions, as it is severely criticized for bearing in mind only virtual realities based on centralized data control. Despite both RGDP and blockchain share common interests in increasing transparency and confidence in online data exchange, the truth is that in several ways misunderstandings between the two are real: certain notions, such as data controller or processor, hardly adequate; certain rights, such as right to be forgotten or the right to data portability risk losing their enforcement; or even certain principles, such as data minimization, are hardly compatible with this new technology

La creació i el sorgiment de nous programes informàtics basats en la tecnologia blockchain desafien el recent GDPR amb noves qüestions, ja que se li critica tenir en compte només les realitats virtuals basades en el control centralitzat de dades. A pesar que tant el RGDP com la blockchain comparteixen interessos comuns per a augmentar la transparència i la confiança en l'intercanvi de dades en línia, la veritat és que, en diversos aspectes, els malentesos entre tots dos són reals: algunes nocions com la de controlador o processador de dades, són poc adequades; certs drets, com el dret a l'oblit o el dret a la portabilitat de les dades corren el risc de perdre la seva aplicació; o fins i tot certs principis, com la minimització de dades, són difícilment compatibles amb aquesta nova tecnología

Digital Diabetes Congress 2018.

Digital health is capturing the attention of the healthcare community. This paradigm whereby healthcare meets the internet uses sensors that communicate wirelessly along with software residing on smartphones to deliver data, information, treatment recommendations, and in some cases control over an effector device. As artificial intelligence becomes more widely used, this approach to creating individualized treatment plans will increase the opportunities for patients, even if they are in remote settings, to communicate with and learn from healthcare professionals. Simple design is needed to promote use of these tools, especially for the purpose of increased adherence to treatment. Widespread adoption by the healthcare industry will require better outcomes data, which will most likely be in the form of safety and effectiveness results from robust randomized controlled trials, as well as evidence of privacy and security. Such data will be needed to convince investors to direct resources into and regulators to clear new digital health tools. Diabetes Technology Society and William Sansum Diabetes Center launched the Digital Diabetes Congress in 2017 because of great interest in determining the potential benefits, metrics of success, and appropriate components of mobile applications for diabetes. The second annual meeting in this series took place on May 22-23, 2018 in San Francisco. This report contains summaries of the meeting's 4 plenary lectures and 10 sessions. This meeting report presents a summary of how 55 panelists, speakers, and moderators, who are leaders in healthcare technology, see the current and future landscape of digital health tools applied to diabetes.

Current Regulation of Mobile Mental Health Applications.

In recent years, the availability of software that is targeted toward the general public and designed to assist in the diagnosis and treatment of mental illness or to promote general mental health has expanded greatly. Regulation of more traditional health care providers and health care-associated devices is well established by statute, regulatory guidelines, and common law precedents. Applications (apps), in contrast, pose a novel regulatory challenge. This review examines the current regulatory guidelines for psychiatric mobile mental health apps, as well as the current state of case law in the psychiatric mobile mental health realm.

[Legal framework for E­health products on the European market]. / Medizinprodukterechtliche Rahmenbedingungen für E­Health-Produkte im europäischen Wirtschaftsraum.

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

[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority]. / Medizinische Software/Medical Apps : Aufgaben, Anforderungen und Erfahrungen aus Sicht einer Überwachungsbehörde.

Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

[Qualification and classification of medical apps : What should be noted and what is BfArM's contribution?] / Abgrenzung und Klassifizierung von Medical Apps : Was ist zu beachten und welche Unterstützung bietet das BfArM?

Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector.For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device.In this context, it is extremely important for manufacturers to decide at an early stage of the development whether the product is to be introduced into the market as a medical device and is therefore subject to the legislation on medical devices.This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.

Information and Communication Technology (ICT) Standards and Guidelines. Final rule.

We, the Architectural and Transportation Barriers Compliance Board (Access Board or Board), are revising and updating, in a single rulemaking, our standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the section 508-based standards and section 255-based guidelines are intended to ensure that information and communication technology covered by the respective statutes is accessible to and usable by individuals with disabilities.