Digital Healthcare Regulatory Perspectives

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Evolving regulatory perspectives on digital health technologies for

(Just Now) WebEvolving regulatory perspectives on digital health technologies for medicinal product development. Seya Colloud 1, Thomas Metcalfe 1, Scott Askin 2, Shibeshih Belachew 3, Johannes Ammann 1, Ernst

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

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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 Freye M, …

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

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Digital Health Experience: A Regulatory Focus Perspective

(6 days ago) WebResults also show that customer experience with digital health technology positively affects customers’ attitudes toward using digital technology. Smith J.S., …

https://journals.sagepub.com/doi/full/10.1016/j.intmar.2021.07.002

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Digital Health Research and Partnerships FDA

(9 days ago) WebBoth regulatory science research and partnerships play an integral role in the Center for Devices and Radiological Health (CDRH) Digital Health Center of …

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

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Evolving regulatory perspectives on digital health technologies for

(1 days ago) WebDigital health technology tools (DHTTs) present real opportunities for accelerating innovation, improving patient care, reducing clinical trial duration and …

https://pubmed.ncbi.nlm.nih.gov/36991116/

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Digital Health Experience: A Regulatory Focus Perspective

(1 days ago) WebDigital technology is an integral part of today's healthcare, yet little is known about how these technologies affect healthcare customers' experience. This study uses …

https://www.sciencedirect.com/science/article/abs/pii/S1094996821000499

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The regulatory gap in digital health and alternative pathways to …

(7 days ago) WebBy 2020, 64 AI/ML-based digital health devices had already received marketing authorization by the U.S. FDA [3]. While adoption by patients and physicians …

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

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The Evolving Regulatory Paradigm of AI in MedTech: A Review

(Just Now) WebArtificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and …

https://link.springer.com/article/10.1007/s43441-024-00628-3

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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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Full article: Unlocking the full potential of digital endpoints for

(6 days ago) WebFigure 1(b) shows the detail of each measurement block, the measurement definition includes a description and justification for the aspect of health and context of …

https://www.tandfonline.com/doi/full/10.1080/14737167.2024.2334347

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Digital health ecosystems: A payer perspective McKinsey

(5 days ago) WebThese ecosystems enable a range of consumer-centric services by establishing a network of digital service providers (Exhibit 2). They run on technology …

https://www.mckinsey.com/industries/healthcare/our-insights/digital-health-ecosystems-a-payer-perspective

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Digital Health Experience: A Regulatory Focus Perspective

(2 days ago) WebThis study identifies how the role of the health care customer is changing and highlights effects of the changing role across the practice approaches, and proposes a …

https://www.semanticscholar.org/paper/Digital-Health-Experience%3A-A-Regulatory-Focus-O'Connor-Myrden/bf0ba825c90ed7969dbb3119c367da9b5970243e

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

(3 days ago) WebThe earliest digital health care applications did not incorporate these principles, and as such, use cases were limited to the automation of paper processes …

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

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Evolving regulatory perspectives on digital health …

(4 days ago) WebREVIEW ARTICLE OPEN Evolving regulatory perspectives on digital health technologies for medicinal product development Seya Colloud 1 , Thomas Metcalfe , Scott Askin2, …

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

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Regulatory Perspective: Digital Health Technology Tools

(5 days ago) WebDigital health technology tools (DHTTs) can help capture patient experiences in real world settings. DHTTs can include, but are not limited to, “wearables” (e.g., accelerometers), …

https://globalforum.diaglobal.org/issue/june-2019/regulatory-perspective-digital-health-technology-tools/

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Regulatory Guidance Digital Health

(3 days ago) WebEmail This List. Regulatory Guidance. The expansion of digital health related technologies has grown rapidly - accelerating even more during the COVID-19 pandemic. As digital …

https://digital.health/regulatory

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Digital Technology and the Political Determinants of Health …

(4 days ago) WebColossal financial investments in digital health technologies are being made across the world, whether smart phone apps for diagnosing, monitoring and facilitating treatment of …

https://onlinelibrary.wiley.com/doi/full/10.1111/1758-5899.13001

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The digital transformation in pharmacy: embracing online …

(6 days ago) WebLastly, examining healthcare financialization and digital division provides an international perspective, contrasting the regulated environment in the EU with the US’s …

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

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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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Patients love telehealth—physicians are not so sure McKinsey

(1 days ago) WebInvestment in digital health companies has grown rapidly—reaching $21.6 billion in 2020, a 103 percent year-over-year increase—which also suggests that this …

https://www.mckinsey.com/industries/healthcare/our-insights/patients-love-telehealth-physicians-are-not-so-sure

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MHRA launches regulatory sandbox for AI medical devices

(5 days ago) WebThe launch of the regulatory sandbox is part of the MHRA’s strategic approach to AI, published in April 2024, which aims to help the government agency “identify and …

https://www.digitalhealth.net/2024/05/ai-airlock-regulatory-sandbox-launched-by-mhra/

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Regulatory and Ethical Perspectives on Pragmatic Trials: Lessons …

(Just Now) WebRegulatory and Ethical Perspectives on Pragmatic Trials: Lessons from Three Cases Mark Neuman, MD, MSc Director, Research Partnerships, Leonard Davis Institute of Health …

https://medicalethicshealthpolicy.med.upenn.edu/master-of-bioethics/new-students/alumni-colloquium-series-2022-23/research-ethics-and-policy-series-reps-three-pragmatic-trials-regulatory-and-ethical-perspectives-mark-neuman-md-msc

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Remote monitoring code changes may be dead

(2 days ago) WebOne source considers the changes “dead.”. The coding panel met May 9-11 in Chicago for its tri-annual discussion of CPT code change applications submitted by …

https://www.fiercehealthcare.com/digital-health/amas-coding-panel-stalled-decision-diversify-remote-monitoring-codes-again

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How do we understand the value of drug checking as a …

(2 days ago) WebParticipants discussed ways that drug checking can fill a regulatory vacuum, serve as a tool of informal market regulation at the community level, and …

https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-024-01014-w

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DESIGN AND DEVELOPMENT OF MEDICAL ELECTRONIC …

(6 days ago) WebDesign and development of medical electronic instrumentation: a practical perspective of the design, construction, and test of material devices / David Prutchi, Michael Norris. p. …

https://onlinelibrary.wiley.com/doi/pdf/10.1002/0471681849.fmatter

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May 2024 Perspectives - National Academy of Medicine

(7 days ago) WebSelect Page. May 2024 Perspectives. May 10, 2024. Join Our Community. Sign up for NAM email updates. Leave this field empty if you're human: 500 5th Street NW Washington, …

https://nam.edu/streamlining-regulatory-oversight-of-respirators-used-in-health-care-settings-will-improve-worker-protection/may-2024-perspectives/

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Artificial Iintelligence in healthcare system: an Italian perspective

(2 days ago) WebSec. Regulatory Science Volume 11 - 2024 doi: 10.3389/fmed.2024.1343456. This article is part of the Research Topic. Healthcare in the age of sapient machines: …

https://www.frontiersin.org/articles/10.3389/fmed.2024.1343456

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Aadhick Solutions Inc

(7 days ago) WebHealthcare. Aadhick Solutions is uniquely positioned in helping the Payers navigate challenges around Population health, ACO, Value-base care, Regulatory reporting and …

http://aadhicksolution.com/

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Policy Experts Call for Easier Access to Healthcare Data for …

(5 days ago) Web<p>Dr. Jeffrey Brenner, a leader in coordinating healthcare initiatives in Camden, said legislation is needed to make data more easily accessible to researchers, …

https://njtechweekly.com/policy-experts-call-for-easier-access-to-healthcare-data-for-research/

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Cano Health wins creditor support to cut debt, exit bankruptcy

(6 days ago) WebMH Illustration. Cano Health Inc. won support from lower-ranking creditors for a plan to slash about $1 billion in debt and exit bankruptcy under new owners. At a court …

https://www.modernhealthcare.com/digital-health/cano-health-bankruptcy-creditor-support-cut-debt

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