Digital Health And Regulatory Issues

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Full article: Technical and regulatory challenges of digital …

(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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Challenges and opportunities of digital health in a post …

(3 days ago) WEBINTRODUCTION. Digital revolution has changed the product and service development in almost all aspects of human life, including human health.[] Digital …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8103966/

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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 …

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

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Regulatory considerations to keep pace with innovation …

(Just Now) WEBThe COVID-19 pandemic has accelerated interest in digital health, with an unprecedented rise in investment in and use of digital tools as medical devices to …

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

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Sync fast and solve things—best practices for responsible …

(Just Now) WEBInclusive co-creation ensures that ethical and societal issues in digital health innovations, such as Iqbal, J. D. & Biller-Andorno, N. The regulatory gap in …

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

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Full article: Gaps in digital health policies: an insight into …

(6 days ago) WEBSafety issues in digital health extend beyond data privacy and regulatory lag, directly impacting patient health. Generally, these concerns can be categorized into …

https://www.tandfonline.com/doi/full/10.1080/13696998.2023.2266955

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The Digital Variome: Understanding Digital Tool Health …

(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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The regulatory gap in digital health and alternative …

(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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Transforming Care and Outcomes with Digital Health …

(4 days ago) WEBThe pandemic has greatly accelerated use of digital health in areas such as public health surveillance and virtual care in many countries, highlighting some of the …

https://catalyst.nejm.org/doi/full/10.1056/CAT.22.0053

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Digital health: trends, opportunities and challenges in

(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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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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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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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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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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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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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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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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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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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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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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Federal Cybersecurity Efforts Seek to Improve Protection of Health …

(2 days ago) WEBHealthcare data breaches affect millions of people every year, and it’s a growing problem. Medical records include financial and personal information that …

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

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Digital Health Laws and Regulations Report 2024 - ICLG

(7 days ago) WEBDigital Health Laws and Regulations 2024. Digital Health Laws and Regulations. 2024. ICLG - Digital Health covers digital health and healthcare IT, …

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

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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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Ascension Hospitals Reel From Cyberattack, Causing Patient Care …

(1 days ago) WEBFor two weeks at the 140-hospital system, doctors and nurses have had little access to digital records for patient histories, resorting to paper and faxes to treat …

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

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AI-Infused Foresight: Unveiling Megatrends for Strategic …

(3 days ago) WEBBroad, Regulatory Frameworks Needed to Responsibly Harness AI. As regulatory frameworks for the AI era continue to evolve, governments around the world …

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

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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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Unlocking your digital health strategy NCPA

(9 days ago) WEBJoin the next Business Booster webinar on June 11, “Unlocking Digital Health: Strategies for iCare+ Commercialization,” presented by IPC, and delve into the realm of …

https://ncpa.org/newsroom/qam/2024/05/28/unlocking-your-digital-health-strategy

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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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Think Tank Review - May 2024 - Consilium

(2 days ago) WEBForecasts and prospects of the June European Parliament election; digital aspects of the EU Single Market and their importance for the EU’s global …

https://www.consilium.europa.eu/en/documents-publications/library/library-blog/posts/think-tank-review-may-2024/

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Nelson Mullins - Nelson Mullins FinTech Attorneys Co-Author …

(2 days ago) WEBNelson Mullins partners Richard Levin and Kevin Tran, and of counsel Bobby Wenner recently co-authored a chapter in Global Legal Insights’ AI, Machine …

https://www.nelsonmullins.com/insights/news/press_releases/nelson-mullins-fintech-attorneys-co-author-chapter-in-global-legal-insights-ai-machine-learning-and-big-data-2024

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

(9 days ago) WEBSeventeen Florida hospitals have closed their maternity units since 2019, according to KFF Health News, which cites information from the Florida Hospital …

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

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Las Vegas physician convicted in $2M fraud scheme - Becker's …

(5 days ago) WEBA physician was convicted by a Nevada federal jury for his role in a nearly $2 million Medicare and Medicaid fraud scheme. Eduardo Abellana, MD, 75, of Las Vegas, …

https://www.beckershospitalreview.com/legal-regulatory-issues/las-vegas-physician-convicted-in-2m-fraud-scheme.html

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The Deloitte Global 2024 Gen Z and Millennial Survey

(1 days ago) WEB2024 Gen Z and Millennial Survey: Living and working with purpose in a transforming world The 13th edition of Deloitte’s Gen Z and Millennial Survey connected with nearly 23,000 …

https://www.deloitte.com/global/en/issues/work/content/genz-millennialsurvey.html

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