Digital Health And Regulatory Issues

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Full article: Technical and regulatory challenges of digital health

(6 days ago) WEBThis editorial provides insights into the main technical and regulatory challenges of digital health development, implementation, and functioning in developing countries (Figure 1). Figure 1. Moreover, data transmission issues may lead to delays …

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

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The Digital Variome: Understanding Digital Tool Health Implications

(9 days ago) WEBThe wave of new digital health products creates regulatory decision challenges that need to be informed by real world data and data that help identify the …

https://www.fda.gov/science-research/advancing-regulatory-science/digital-variome-understanding-implications-digital-tools-health

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Health Policy and Privacy Challenges Associated With Digital …

(3 days ago) WEBThe views of the experts who we interviewed are in line with an increasing body of academic and lay literature on the relevance of digital information to health. …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7348687/

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The regulatory gap in digital health and alternative pathways to …

(7 days ago) WEBThere is no regulatory class specific to Digital Health Technologies. To ensure quality, safety, and efficacy of products with medical or health-associated uses, …

https://www.sciencedirect.com/science/article/pii/S2211883722000703

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Regulatory considerations to keep pace with innovation in digital

(Just Now) WEBThe digital health company Big Health currently releases its mental health and insomnia apps tested in randomized controlled trials through this regulatory scheme.

https://www.nature.com/articles/s41746-022-00668-9

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Digital Health: the legal and regulatory issues to consider

(5 days ago) WEBDigital Health: the legal and regulatory issues to consider. The digital health industry has grown significantly in the recent years. With increasing financial …

https://www.ropesgray.com/en/insights/viewpoints/102hjqj/digital-health-the-legal-and-regulatory-issues-to-consider

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Advancing digital health: FDA innovation during COVID-19

(4 days ago) WEBThe FDA has sought to expand access to clinically-appropriate, low-risk digital health tools during the COVID-19 pandemic by stating its intention not to enforce certain regulatory …

https://www.nature.com/articles/s41746-020-00371-7.pdf

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Integration of Digital Health Tools into Clinical Practice

(8 days ago) WEBProject Start Date: May 1, 2018 Project End Date: February 28, 2022. While FDA funding of this project has ended, the research continues to evolve and result in …

https://www.fda.gov/science-research/advancing-regulatory-science/developing-frameworks-and-tools-integration-digital-health-tools-clinical-practice

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Global strategy on digital health 2020-2025 - World Health …

(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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Decoding Digital Health: AI/ML Webinar Recap—U.S. FDA

(6 days ago) WEBTranscript: Kellie Combs: Welcome to Decoding Digital Health, a Ropes & Gray podcast series focused on legal, business and regulatory issues impacting the …

https://www.ropesgray.com/en/insights/podcasts/2024/05/decoding-digital-health-aiml-webinar-recap-us-fda-european-perspectives

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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: 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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Digital Health Research and Partnerships FDA

(9 days ago) WEBCDRH’s DHCoE fosters digital-health focused collaborations that advance public health including the following: FDA’s Centers of Excellence in Regulatory …

https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-research-and-partnerships

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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 Trends and Their Legal Issues - National Law Review

(4 days ago) WEBEmail. 212-634-3062. Bio and Articles. HB Ad Slot. Top 5 Legal Issues in Digital Health to Watch for in 2022. by: Allison Fulton, John D. Carroll, Sara Helene …

https://www.natlawreview.com/article/top-5-legal-issues-digital-health-to-watch-2022

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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: but privacy and security concerns prevented the enactment of necessary regulatory action. …

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

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Current regulatory challenges to support the spread of digital …

(2 days ago) WEB2. Regulatory environment for digital health technologies in England 2.1 Regulatory map of key stakeholders . There are a number of policy-making bodies involved in digital …

https://www.city.ac.uk/__data/assets/pdf_file/0007/569689/CHIR-Report_July2020_Regulatory-challenges-and-opportunities-for-digital-health-technology.pdf

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Key Issues as Wearable Digital Health Technologies Enter Clinical …

(1 days ago) WEBThe authors address the issues that must be confronted if we are to integrate the use of wearable digital health technologies into clinical care in a way that …

https://www.nejm.org/doi/full/10.1056/NEJMra2307160

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Regulation of Digital Healthcare in India: Ethical and Legal - MDPI

(9 days ago) WEBIn the wake of the COVID-19 pandemic, digital healthcare has gained an influx of interest and global investment. The WHO has published guidelines and …

https://www.mdpi.com/2227-9032/11/6/911

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5 Digital Health Issues to Watch at FDA in 2022

(5 days ago) WEBIn sum, expect an active FDA in 2022. 2. AI/ML-Based Software Regulation. FDA recognizes the potential for AI/ML-based software to transform healthcare and has …

https://www.covingtondigitalhealth.com/2022/01/5-digital-health-issues-to-watch-at-fda-in-2022/

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Digital Health Regulatory Issues to Watch in 2020 - NextGen

(1 days ago) WEBFrom the widespread adoption of electronic health records (EHRs), to the advances (and failures) of patient data interoperability, the digital health industry over the past decade …

https://www.nextgen.com/blog/digital-health-regulatory-issues

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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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Federal Cybersecurity Efforts Seek to Improve Protection of Health …

(2 days ago) WEBThe rise in data breaches has prompted the federal government to step up its efforts to improve healthcare cybersecurity, most recently through its Digital Health …

https://journal.ahima.org/page/federal-cybersecurity-efforts-seek-to-improve-protection-of-health-data

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Ascension Hospitals Reel From Cyberattack, Causing Patient Care …

(1 days ago) WEBAscension, one of the nation’s largest medical systems with 140 hospitals in 19 states, has yet to recover from a large-scale cyberattack earlier this month. Lauren …

https://www.nytimes.com/2024/05/23/health/cyberattack-ascension-hospitals-patient-data.html

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Ethical and Regulatory Considerations for Digital Health …

(5 days ago) WEBThe workshop featured a briefing on ethical considerations related to digital health technologies (DHTs) from a behavioral science perspective by Camille Nebeker, …

https://www.ncbi.nlm.nih.gov/books/NBK563599/

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Digital health: a case of mistaken identity - STAT

(1 days ago) WEBMany digital health companies failed to heed the lesson, and the results have been predictable. Technology has upended virtually every known industry and customer …

https://www.statnews.com/2024/05/22/digital-health-companies-medicines/

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The advancement of artificial intelligence in biomedical research …

(4 days ago) WEBArtificial intelligence to address global health issues. The way drug discovery systems are organized and funded has so far proven incapable of solving …

https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-024-01049-5

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Why UMass invested millions in 'hospital at home' - Becker's …

(5 days ago) WEBDespite being a $3.8 billion organization, making it about the 150th largest U.S. health system, UMass Memorial has one of the most robust hospital-at-home …

https://www.beckershospitalreview.com/digital-health/why-umass-invested-millions-in-hospital-at-home.html

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AI-Infused Foresight: Unveiling Megatrends for Strategic …

(3 days ago) WEBAI-Infused Foresight: Unveiling Megatrends for Strategic Adaptation. In the dynamic global landscape, several distinct megatrends have emerged as pivotal forces …

https://www.isaca.org/resources/isaca-journal/issues/2024/volume-3/ai-infused-foresight-unveiling-megatrends-for-strategic-adaptation

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Congress and the Executive Branch and Health Policy KFF

(Just Now) WEBThe federal government is not the only place health policy is made in the U.S., but it is by far the most influential. Of the $4.5 trillion the U.S. spent on health in …

https://www.kff.org/health-policy-101-congress-and-the-executive-branch-and-health-policy/

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Regulation of Digital Healthcare in India: Ethical and Legal …

(4 days ago) WEBIn this paper, I analyze the legal, structural, and ethical concerns around digital health and provide an understanding of the problems these shortcomings pose, as well as policy …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10048681/

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PE-owned physician group backed Florida C-section policy shift

(9 days ago) WEBA debated Florida law that allows physicians to perform cesarean deliveries outside of hospitals came about after backing by a private equity-owned physicians …

https://www.beckershospitalreview.com/legal-regulatory-issues/pe-owned-physician-group-backed-florida-c-section-policy-shift.html

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CFIA 2025 Framework: Building for the future - inspection.canada.ca

(2 days ago) WEBAn agile regulatory environment will also allow the CFIA to be flexible. Agility when delivering critical services that protect food safety, animal health, plant health and …

https://inspection.canada.ca/en/about-cfia/cfia-2025/framework

Category:  Food Show Health

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