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US Regulatory Pathways for Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Michelle Rubin-Onur, Allison C. Komiyama
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, was partly designed to help accelerate medical product development, including the function of the software in medical devices.3 The Cures Act removed certain software functions described in section 520(o)(1)(A)-(D) of the FD&C Act and included the limited circumstances when software functions in those sections would remain devices. Ultimately, FDA saw these changes as an efficient way to bring innovations and technological advances to patients and their caregivers. The law builds on FDA's regulations regarding digital health and expands on digital health technologies. More specifically, Section 3060(a) of this legislation, titled “Clarifying Medical Software Regulation,” amended the FD&C Act to exclude software intended for administrative support for a healthcare facility, software intended for maintaining or encouraging a healthy lifestyle (as known as general wellness software), software intended to serve as electronic patient records, and software intended for transferring, storing, converting formats, and displaying data and results.
Regulatory Considerations When Deploying your Software in a Clinical Environment
Published in Johan Helmenkamp, Robert Bujila, Gavin Poludniowski, Diagnostic Radiology Physics with MATLAB®, 2020
Philip S. Cosgriff, Johan Åtting
Nearly all medical software is constructed within the framework of a “programming environment” containing a high level language, library modules, and run-time functions. Suitable development packages (e.g., MATLAB, Maple) can be obtained from commercial suppliers or, alternatively, from open source providers (e.g., Python, IQWorks, OpenCV). Elements of these systems are thereby integrated into user-written software, so the question arises as to whether these “ready-made building blocks” need to be QA-checked by the developer?
End-User's Emotion and Satisfaction
Published in Arvind Kumar Bansal, Javed Iqbal Khan, S. Kaisar Alam, Introduction to Computational Health Informatics, 2019
Positive and satisfying interaction between end-users and medical software can improve the quality of care, enhance patients' participation in their own health care and increase the efficiency of healthcare encounters. The potential is achieved if a positive emotional experience is engendered for multiple stakeholders. Positive engagement improves the probability of stakeholders heeding the information and following the instructions. An example of positive interaction is when a specialist doctor (or a patient) can intuitively mark the related abnormality on a visual rendering of a human part instead of giving a whole lot of textual descriptions.
Prevalence of virtual reality (VR) games found through mental health categories on STEAM: a first look at VR on commercial platforms as tools for therapy
Published in Nordic Journal of Psychiatry, 2022
Almira Osmanovic Thunström, Iris Sarajlic Vukovic, Lilas Ali, Tomas Larson, Steinn Steingrimsson
All of the games which have been included would have to be carefully vetted through a gameplay by several independent psychiatric specialists in order to determine their feasibility as therapeutic tools in treatment of psychiatric disorders. Another issue that should be brought to life is regulatory aspects of using games which have not been vetted or registered as health care technology. According to policy and regulations such as the European medical device regulatory law (MDR 745/2017), all medical software should be registered and vetted before use on patients. The same applies for (for example) the American Food and Drug Administration (FDA). None of these games which are included in our list are CE marked, FDA approved or registered as medical technology. A broader discussion needs to be had about the future and current role of commercially available games and how to ensure they can safely be used in clinical settings in accordance to current regulations.
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software
Published in Expert Review of Medical Devices, 2022
Jae Hyun Woo, Eun Cheol Kim, Sung Min Kim
Meanwhile, harmonization of laws and regulations applicable to medical devices has evolved worldwide over the years, including the International Medical Device Regulators Forum (IMDRF). Since its establishment in 1992, IMDRF has devoted itself to harmonizing international standards with national regulations and issued harmonized guidelines for implementation by regulators, industry, and compliance agencies (CAB). The IMDRF regulatory model is intended to be used by regulators to develop a medical device management framework [24–29] by its members from the United States, Europe, Japan, Canada, China, Brazil, Russia, Australia, Korea, and Singapore in addition to the World Health Organization (WHO), official observers, and Pan American Health Organization (PAHO). Member States of the IMDRF have contributed to technological innovation in the global medical market with a high market share. They also presented a framework for increasing medical software. Among them, the FDA served as the chair of the working group on SaMD and developed related guidelines. The MFDS organized the Artificial Intelligence Medical Devices program to develop ‘Machine Learning-enabled Medical Devices’ for publication [30] (https://www.imdrf.org/).
The incidence of lower respiratory tract infections and pneumococcal vaccination status in adults in flemish primary care
Published in Acta Clinica Belgica, 2021
Tine De Burghgraeve, Séverine Henrard, Bart Verboven, Gijs Van Pottelbergh, Bert Vaes, Catharina Mathei
Data were obtained from Intego, a Flemish general practice-based morbidity registration network, based at the Academic Centre for General Practice at the University of Leuven [26]. All the information is routinely collected in the electronic health records by the general practitioner (GP) during daily practice. Currently, 111 GPs, all using the medical software program Medidoc®, are collaborating in the Intego project. These GPs work in 49 practices evenly spread throughout Flanders, the northern part of Belgium. Patients in this registration network cover about 2% of the Flemish population. The Intego GPs prospectively and continuously register all new diagnoses together with new drug prescriptions, laboratory test results, vaccinations, and some background information (including sex and year of birth) using computer-generated keywords linked to codes. Using specially framed extraction software, new data were collected on a yearly basis from the computers of the participating GPs by a trusted third party and entered into a central database. Registered data were continuously updated, accumulating a history for each patient.