Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes

Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this process, the FDA has proposed a new rule for regulating combination products. This iBrief discusses the FDA\u27s current approach and analyzes the possible affects of the proposed regulation. Because of the many shortcomings of both systems, this iBrief concludes that the FDA should instead stop assigning center jurisdiction based on a product\u27s primary mode of action, and give the Office of Combination Products internal agency jurisdiction over combination products. This alternative approach would increase consistency and efficiency while maintaining the FDA\u27s high standards for medical product safety and efficacy

Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials

Medical device technologies: Who is the user?

A myriad of medical devices deployed by many users play an essential role in healthcare, and they, and their users, need to be defined, classified and coded effectively. This study provides definitions of terms frequently employed to describe the users of medical device technologies (MDT) as well as a classification of such users. Devices are widely used, developed and assessed by many others than clinicians. Thus, users of medical devices need to be classified in various relevant ways, such as primary and secondary users; user groups such as healthcare professionals, patients, carers, persons with disabilities, those with special needs, as well as professionals allied with healthcare. Proper definition and classification of MDT users is particularly important for integrating the users’ perspectives in the process of MDT development and assessment, as well as in relation to the regulatory, health and safety, and insurance perspectives concerning MDT

The consolidation process of the EU regulatory framework on nanotechnologies: within and beyond the EU case-by-case approach

The field of nanotechnologies has been the subject of a process of wide-ranging regulation, which covers two different trends. From the 2000s the European Commission and Parliament agreed on a type of adaptive, experimental and flexible approach, which had its apex with the Commission code of conduct on responsible nano-research developed through a set of consultations. In 2009 this initial agreement subsequently broke down and the EU started to develop a set of regulatory initiatives of a sectoral nature in several fields (cosmetics, food, biocides). Thus, the current arrangement of governance in the field of nanotechnologies appears to be a hybrid, which mixes forms belonging to the new governance method (consultations, self-regulation, agency, comitology committees, networking), working like a lung in the framework of EU policy, with more traditional tools belonging to the classic governance method (regulations, directives). This model of governance based on a case-by-case approach runs the risk of lacking coherence since it is exposed to sudden changes of direction when risks emerge and it has a weak anticipatory dimension due to both its excessive dependency on data collection and its insufficient use of upstream criteria, such as human rights, which should be used earlier, to allow anticipated intervention with a less intense use of hard law solutions

mHealth Research Applied to Regulated and Unregulated Behavioral Health Sciences

Behavioral scientists are developing new methods and frameworks that leverage mobile health technologies to optimize individual level behavior change. Pervasive sensors and mobile apps allow researchers to passively observe human behaviors “in the wild” 24/7 which supports delivery of personalized interventions in the real-world environment. This is all possible because these technologies contain an incredible array of sensors that allow applications to constantly record user location and can contextualize current environmental conditions through barometers, thermometers, and ambient light sensors and can also capture audio and video of the user and their surroundings through multiple integrated high-definition cameras and microphones. These tools are a game changer in behavioral health research and, not surprisingly, introduce new ethical, regulatory/legal and social implications described in this article