Digital Health Regulation Paper

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Evolving regulatory perspectives on digital health …

(Just Now) WebDigital health technology tools (DHTTs) present real opportunities for accelerating innovation, improving patient care, reducing clinical trial duration and minimising risk in medicines development.

https://www.nature.com/articles/s41746-023-00790-2

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WHO Digital Health Guidelines: a milestone for global …

(Just Now) WebIntroduction. On April 17, 2019, the World Health Organization (WHO) reached a new milestone as it released the first evidence-based guidelines on digital …

https://www.nature.com/articles/s41746-020-00330-2

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Global strategy on digital health 2020-2025 - World …

(7 days ago) Webdigital health 19 2. Advance the implementation of national digital health strategies 21 3. Strengthen governance for digital health at global, regional and national levels 23 4. …

https://apps.who.int/iris/bitstream/handle/10665/344249/9789240020924-eng.pdf

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A PATH TO PATIENT CENTERED DIGITAL HEALTH …

(7 days ago) Webaccuracy of digital health applications and ensure their safety and effectiveness for patients. Second, many digital health applications are not designed in a way to promote …

https://law.yale.edu/sites/default/files/area/center/solomon/document/digital_health_policy_paper_final.pdf

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Full article: Technical and regulatory challenges of digital …

(6 days ago) WebAnother significant challenge in digital health regulation is the shortage of technical expertise among regulatory staff. This shortfall hinders the successful implementation …

https://www.tandfonline.com/doi/full/10.1080/13696998.2023.2249757

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A Framework for Digital Health Policy: Insights from …

(1 days ago) WebIntroduction. Digital health technologies represent a growing market share due in part to rapid advances in wireless technology and computing power as well as …

https://journals.plos.org/digitalhealth/article?id=10.1371%2Fjournal.pdig.0000382

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Reimagining Digital Health Regulation - Deloitte US

(5 days ago) Webreview. This paper synthesizes various ideas developed by a number of individuals and working groups into an integrated, high-level framework that can be used to inform …

https://www2.deloitte.com/content/dam/Deloitte/us/Documents/public-sector/reimagining-digital-health-regulation.pdf

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The Promise of Digital Health: Then, Now, and the Future

(3 days ago) WebThe discussion paper Digital Health COVID-19 Impact Assessment: Lessons Learned and Compelling Needs was produced in parallel to and in coordination …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9499383/

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Guidances with Digital Health Content FDA

(1 days ago) WebList of FDA Guidance Documents with Digital Health Content. Issue Date. Guidance. Guidance Status. 08/11/2023. Off-The-Shelf Software Use in Medical Devices. Final. …

https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content

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The regulatory landscape for digital health apps needs reform - STAT

(1 days ago) WebThe current regulatory landscape for digital health apps needs to be reformed. Since the fall of 2020, working with a team of 19 student researchers at Yale’s …

https://www.statnews.com/2021/08/03/refor-regulatory-landscape-digital-health-applications/

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Digital Health Regulation In Asia-Pacific

(2 days ago) WebThis position paper is intended to be shared with regulators with the aim of aiding the creation of a fit-for-purpose regulatory 004 <<<< Overview of Digital Health …

https://apacmed.org/wp-content/uploads/2021/01/APACMed-Digital-Health-Regulation-in-APAC.pdf

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Digital Health Yale Law School

(2 days ago) WebThe project was also presented on June 10, 2021 to scholars at the Health Law Professors Conference. This policy paper, “A Path to Patient-Centered Digital Health Regulation,” …

https://law.yale.edu/solomon-center/projects-publications/digital-health

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Digital Health Regulation In India - APACMed

(Just Now) Webadoption of Digital Health (DH) solutions in the region, especially as a result of the COVID-19 pandemic, the focus of the Committee is to seek greater harmonization around topics …

https://apacmed.org/wp-content/uploads/2021/10/Digital-Health-Regulation-in-India_Position-Paper.pdf

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Assessing the future of regulating the digital health landscape

(2 days ago) WebRegulation has as an important role to play in demonstrating to the public, and to users, the trustworthiness of the system to build confidence in the use of data, …

https://www.digitalhealth.net/2021/11/assessing-the-future-of-regulating-the-digital-health-landscape/

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Digital Health Regulation in Asia-Pacific - apacmed.org

(3 days ago) Webthe paper’s content. To provide regulators with recommendations that enable the implementation of a harmonized framework, supporting the 004 <<<< Digital Health …

https://apacmed.org/wp-content/uploads/2021/10/DHC-Regulatory-Paper_China-Korea.pdf

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Digital health: trends, opportunities and challenges in - Springer

(Just Now) WebDigital health interventions refer to the use of digital technology and connected devices to improve health outcomes and healthcare delivery. This includes telemedicine, electronic …

https://link.springer.com/article/10.1007/s40012-023-00380-3

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Sync fast and solve things—best practices for responsible digital …

(Just Now) WebResults. Our data highlights the need for stakeholders in digital health (DH) to adapt specific governance and innovation best practices to meet ethical and societal …

https://www.nature.com/articles/s41746-024-01105-9

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Ask a Question About Digital Health Regulatory Policies FDA

(2 days ago) WebQuestions about Medical Device Regulation. Please send these questions to the Division of Industry and Consumer Education (DICE) at 1-800-638-2041 or …

https://www.fda.gov/medical-devices/digital-health-center-excellence/ask-question-about-digital-health-regulatory-policies

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HHS Announces Next Steps in Ongoing Work to Enhance

(Just Now) WebThe paper details four pillars for action, including publishing new voluntary health care-specific cybersecurity performance goals, working with Congress to develop …

https://www.hhs.gov/about/news/2023/12/06/hhs-announces-next-steps-ongoing-work-enhance-cybersecurity-health-care-public-health-sectors.html

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Digital Health Laws and Regulations Report 2024 USA

(1 days ago) WebThe key issues for digital platform providers are: Compliance with data privacy laws, including the HIPAA, CCPA, and HITECH Act with regard to health data …

https://iclg.com/practice-areas/digital-health-laws-and-regulations/usa

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Digital Health Technologies for Remote Data Acquisition in Clinical

(9 days ago) WebThis guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on …

https://www.federalregister.gov/documents/2023/12/22/2023-28262/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations-guidance-for

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The digital transformation in pharmacy: embracing online …

(6 days ago) WebThe paper also examined the impact of digital technologies on pharmacy practice and education, with a focus on telepharmacy services, e-prescribing software, …

https://jhpn.biomedcentral.com/articles/10.1186/s41043-024-00550-2

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House subcommittee passes legislation on telehealth, hospital-at …

(9 days ago) WebThe House Energy and Commerce Subcommittee on Health May 16 passed a number of bills during a markup session, including AHA-supported legislation. The …

https://www.aha.org/news/headline/2024-05-16-house-subcommittee-passes-legislation-telehealth-hospital-home-during-markup-session

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Electronic Health Records (EHR) American Medical Association

(1 days ago) WebAn electronic health record (EHR) digitizes a patient’s paper chart. It collects the patient’s history of conditions, tests and treatments and can be used to create a more …

https://www.ama-assn.org/topics/electronic-health-records-ehr

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The Effectiveness and Safety of a Mobile Application Based Self

(9 days ago) WebThese preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making …

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4831840

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Digital Transformation In Healthcare: Advice For Health - Forbes

(7 days ago) WebEHRs are the digital core of modern healthcare. They revamp how we document and deliver care. These comprehensive records tell a detailed story of a …

https://www.forbes.com/sites/forbestechcouncil/2024/05/22/digital-transformation-in-healthcare-advice-for-health-organizations/

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The EU passes the AI Act and its implications for digital - Nature

(Just Now) WebRegulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) No …

https://www.nature.com/articles/s41746-024-01116-6

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Digital Health Regulation In Asia-Pacific: China and Korea

(2 days ago) WebThe APACMed Digital Health Committee published a first position paper Digital Health Regulation in Asia-Pacific: Overview and Best Practices calling for the …

https://apacmed.org/digital-health-regulation-in-asia-pacific-overview-and-best-practices-2/

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Plans for long-awaited digital health records goes to Cabinet with …

(9 days ago) Web6.31am, 21 May 2024. 2. GOVERNMENT PLANS TO push ahead with plans to roll out digital health records that will enable healthcare workers to quickly view a …

https://www.thejournal.ie/digital-medical-records-cabinet-memo-6384672-May2024/

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Scholarly Article or Book Chapter E-Cigarette Health Harm …

(Just Now) WebPoster, Presentation, Protocol or Paper. Deposit scholarly works such as posters, presentations, research protocols, conference papers or white papers. If you …

https://cdr.lib.unc.edu/concern/articles/s1784x78v

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Consultation paper 2 - Department of Health and Aged Care

(4 days ago) WebThis second consultation paper outlines the details of the proposed approach to regulating aged care. The Department of Health and Aged Care acknowledges the …

https://www.health.gov.au/resources/publications/a-new-model-for-regulating-aged-care-consultation-paper-2-details-of-the-proposed-new-model-full-report?language=en

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