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Building the Story of Scientific Evidence for Digital Therapeutics: Trials, Meta-Analysis, and Real-World Data
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Derek Richards, Angel Enrique, Jorge Palacios, Nora Eilert
In Australia, the Therapeutic Goods Administration (TGA) undertook a modification of the regulations for medical devices to clarify the regulation of digital therapeutics.6 Fundamentally, the modification aimed to provide a more adaptive regulation of digital medical devices so that they are not subject to unnecessary regulatory oversight. These changes included a description of what regulated software products are, the introduction of new classification rules, and adjustments to essential principles to cover the requirements for these devices. Similar to other countries' efforts, the Australian regulatory framework is risk-weighted and outcomes-based. As part of the classification, it has included a category called Digital Medical Devices that mirrors the category of SaMD used by the FDA. The TGA conceptualizes a Digital Health Roadmap comprised of seven stages towards final marketing, including gathering feasibility data, proof of concept, and evidence generation to support the claims, without much specification on the clinical trial requirements.
Consumer Access and Control of Data, Data Sharing, Consumer Participation
Published in Connie White Delaney, Charlotte A. Weaver, Joyce Sensmeier, Lisiane Pruinelli, Patrick Weber, Nursing and Informatics for the 21st Century – Embracing a Digital World, 3rd Edition, Book 4, 2022
Technology trends are changing to meet new policies that create opportunities for consumers to access, control and share their health information. Increasingly in healthcare, emerging technologies are moving away from business to consumers (B2C) models and into consumer to business (C2B) models that aim to improve consumer health, engagement and empowerment. The B2C models exchange goods and services direct to consumers (Amazon, Walmart). In contrast, the C2B models allow consumers to be influencers; in some cases, a consumer can receive a commission for their insights and demand is driven by consumer requests for certain services or products. Through consumers answering basic sets of questions, healthcare organizations can tailor their interaction with patients and their caregivers. That means that healthcare C2B models are ‘customized to me.' The needs of the individual end-user determine what the service looks like making innovation part of the goal. Healthcare is experiencing a shift into C2B through telemedicine, mobile, on-demand consumer health applications (apps) and behavior modification tools (NOOM; Livongo, 2021). The 21st Century Cures Act and related policies open up endless possibilities to a future where consumers and their input become key to future proofing new innovations and products. Ease of use of these new consumer-oriented apps will ensure consumer adoption with gains in self-directed, health promotion and participation in care-as-a-service (CaaS) platforms.
Cellular Grafting Techniques
Published in Vineet Relhan, Vijay Kumar Garg, Sneha Ghunawat, Khushbu Mahajan, Comprehensive Textbook on Vitiligo, 2020
There is ongoing research to simplify the procedure of noncultured cellular grafting, and modifications with respect to safety of the procedure and to reduce the cost of treatment. These modifications have significantly helped in reducing the cost of treatment and enabling its use in resource-limited settings. The methods are being revised rapidly to achieve a concentrated pigment cell population for transplantation.
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives
Published in Expert Review of Medical Devices, 2023
Alan G Fraser, Elisabetta Biasin, Bart Bijnens, Nico Bruining, Enrico G Caiani, Koen Cobbaert, Rhodri H Davies, Stephen H Gilbert, Leo Hovestadt, Erik Kamenjasevic, Zuzanna Kwade, Gearóid McGauran, Gearóid O’Connor, Baptiste Vasey, Frank E Rademakers
In the USA, the FDA has proposed a total product lifecycle (TPLC) regulatory approach to AI – and ML‒based SaMD. Its principles include initial premarket assurance of safety and effectiveness, SaMD prespecifications (SPS), an algorithm change protocol (ACP), transparency, and monitoring of real-world performance (RWP). The paper in April 2019 on a ‘Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device’ [48] has been influential. After public consultation, the FDA published its response in 2021 with an action plan that includes a tailored regulatory framework for AI–ML‒based SaMD and the design of regulatory science methods ‘to eliminate algorithm bias and increase robustness’ [145]. A detailed review of US legislation relevant to AI medical devices was published by the National Academy of Medicine [146].
Feasibility of a reablement-program in a Swedish municipality
Published in Scandinavian Journal of Occupational Therapy, 2023
In 35 cases (56%), one or more relatives were included in some phase of the assessment and/or planning of the intervention. In 55 cases (89%), the actions initiated by OTs and PTs included collaboration with other professionals within the organization, including home care staff (n = 27), district nurses (n = 26), OTs (n = 24), PTs, (n = 14), social workers (n = 7), and other staff (n = 5, e.g. companion service, relief service in the home for next-of-kin). In 30 cases, the collaboration included three or more professionals (including the respondent). In 19 cases (30%), the intervention included collaboration with stakeholders outside the organization, including staff within specialized health care (n = 12), staff within primary care (n = 5), staff managing home modification (n = 1), a repair person (n = 1), staff handling technical aids (n = 1), and a trustee (n = 1).
Increasing access to quality healthcare through collaborative leadership
Published in International Journal of Healthcare Management, 2020
Increasing and ensuring improved access to quality healthcare service requires healthcare leaders to engage the relevant individuals to ensure their involvement in identifying modifications that need to be made to the existing structure [10]. With the ever-evolving complexity of challenges to healthcare access, there is a need for healthcare leaders to employ collaborative leadership skills to promote collective efforts by all relevant entities toward enhancing that access [11]. In this study, collaborative leadership refers to a leadership approach that takes into account the efforts available across organizational boundaries [12,13]. Al-Sawai [9] indicated that the collaborative leadership approach ensures that the different departments and individuals are interdependent and their activities are synchronized. As a result, it enhances the potential for achieving the set goal of improving access to quality healthcare service. Enhanced collaborative efforts can only be realized if leaders promote the modeling of collaborative behavior, motivate the workforce, and constantly nurture interdependency between different stakeholders in the healthcare system [14].