Digital Health Apps Legislation

Listing Websites about Digital Health Apps Legislation

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Mobile Health App Interactive Tool Federal Trade …

(3 days ago) WEBThe FDA focuses its regulatory oversight of digital health devices on a subset of mobile health apps that could pose a risk to consumers if they don’t work as intended. The FDA considers a software function to be a medical device, and subject to …

https://www.ftc.gov/business-guidance/resources/mobile-health-apps-interactive-tool

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Direct-to-Consumer Health Apps: Ethical, Legal, and - Bill of Health

(Just Now) WEBDirect-to-consumer (DTC) health apps, such as apps that manage our diet, fitness, and sleep, are becoming ubiquitous in our digital world. These apps provide a window into …

https://blog.petrieflom.law.harvard.edu/in-focus/direct-to-consumer-health-apps/

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FTC finalizes changes to health breach notification rule

(8 days ago) WEBFTC finalizes changes to data privacy rule to step up scrutiny of digital health apps. The FTC's Health Breach Notification Rule dates back to 2009. Since the rule’s issuance, health apps and

https://www.fiercehealthcare.com/health-tech/ftc-finalizes-changes-data-privacy-rule-step-scrutiny-digital-health-apps

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Multinational landscape of health app policy: toward …

(Just Now) WEBIn 2020, more than 91,000 digital health apps were released in app stores, averaging 250 new apps per day 1. The authors examined national healthcare …

https://www.nature.com/articles/s41746-022-00604-x

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Should We Regulate Direct-to-Consumer Health Apps?

(3 days ago) WEBThere should ultimately be a line drawn surrounding digital health apps for wellness, compared to those that are intended to address a specific disease as a …

https://blog.petrieflom.law.harvard.edu/2021/09/01/direct-to-consumer-health-apps-regulation/

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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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Regulating digital health apps needs user-centered reform

(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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AHLA - Digital Health Equity: Narrowing the - American …

(5 days ago) WEBABSTRACT: Since the onset of the COVID-19 pandemic, digital solutions, including mobile health apps, patient portals, and telehealth serve as a critical access …

https://www.americanhealthlaw.org/content-library/journal-health-law/article/9db38c74-ca4e-4e9c-810d-063fdad6b7b4/Digital-Health-Equity

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Digital Health Policy Navigator FDA

(Just Now) WEBThe Digital Health Policy Navigator was developed to aggregate the FDA's device digital health guidance documents, including those that interpret the 21st …

https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator

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Health app policy: international comparison of nine …

(Just Now) WEBJoseph C. Kvedar. npj Digital Medicine (2022) An abundant and growing supply of digital health applications (apps) exists in the commercial tech-sector, which …

https://www.nature.com/articles/s41746-022-00573-1

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Digital Health and Telehealth - American Bar Association

(2 days ago) WEBDigital health includes not only telehealth and telemedicine, but also personalized medicine, remote patient monitoring (RPM), mobile health, health IT, …

https://www.americanbar.org/groups/health_law/publications/aba_health_esource/2022-2023/september-2022/digital-health-and-telehealth-navigating-the-current-legal-framework/

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Multinational landscape of health app policy: toward …

(4 days ago) WEBStrategies to increase transparency, organize app marketplaces, and monitor existing apps are needed to ensure that the global wave of new digital health tools fullls. its promise …

https://www.nature.com/articles/s41746-022-00604-x.pdf

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HIPAA & Health Apps HHS.gov

(1 days ago) WEBHealth App Use Scenarios & HIPAA - This guidance details various use scenarios for mHealth applications, and explains when an app developer may be acting …

https://www.hhs.gov/hipaa/for-professionals/special-topics/health-apps/index.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 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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Rise in Use of Mental Health Apps Raises New Policy Issues

(5 days ago) WEBConsumer Protection. Use of digital behavioral health services increased during the COVID-19 pandemic when in-person visits were limited. This brief examines …

https://www.kff.org/mental-health/issue-brief/rise-in-use-of-mental-health-apps-raises-new-policy-issues/

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Examining health apps and wearable use in improving physical

(Just Now) WEBHealth apps and wearables are touted to improve physical health and mental well-being. However, it is unclear from existing research the extent to which …

https://www.nature.com/articles/s41598-024-61268-z

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Digital Health Law: What Digital Health Companies Need to

(4 days ago) WEBDigital health apps may be subject to regulation by the Food and Drug Administration (FDA). FDA guidance has stated that the agency intends to regulate health apps that …

https://www.venable.com/insights/publications/2017/08/digital-health-law-what-digital-health-companies-n

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What is Digital Health? FDA

(8 days ago) WEBDigital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of …

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

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New FTC rule requires digital health apps to notify users of data …

(4 days ago) WEBThe revised Health Breach Notification Rule (HBNR) requires vendors that manage digital health records that are not covered by HIPAA to notify individuals, the …

https://www.benefitspro.com/2024/05/10/new-ftc-rule-requires-digital-health-apps-to-notify-users-of-data-breaches/

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

(3 days ago) WEBIn the digital age, regardless of the specific barrier to the creation and support of individual and population health (e.g., COV-ID-19, staff burnout, challenging …

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

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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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Recognising the value of digital health apps: An assessment …

(4 days ago) WEBfor health apps were chosen for consideration because the field of health apps is dynamic and continuously evolving, among other reasons due to accelerated …

https://www.medtecheurope.org/wp-content/uploads/2021/11/2111_v4.8_mte_dht_reimbursement16.11.2021-2.pdf

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Digital Health Laws and Regulations United Kingdom 2024

(2 days ago) WEBNHS Digital, which currently has the role as statutory custodian for health and social care data for England, taking a role in creating data collections, data sets and …

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

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Health care groups: Regulate AI, but not too much - POLITICO

(9 days ago) WEBCongressional leaders unveiled legislation that would set a two-year deadline for Oracle Cerner and the Department of Veterans Affairs to hit certain metrics in their …

https://www.politico.com/newsletters/politico-pulse/2024/05/15/health-care-groups-regulate-ai-but-not-too-much-00157910

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Digital Health Laws and Regulations Germany 2024

(5 days ago) WEBThe law is expected to come into force at the beginning of 2024. Similar to the DiGA concept, a new system for the reimbursement of digital care applications ( …

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

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Driving the digital transformation of Germany’s healthcare …

(9 days ago) WEBApps on prescription, easy use of online video consultations and access to a secure healthcare data network for treatment everywhere – all achievements of the “Act to Improve Healthcare Provision through Digitalisation and Innovation” (Digital Healthcare Act – DVG), which was approved on 7 November 2019 by the Bundestag and adopted on

https://www.bundesgesundheitsministerium.de/en/digital-healthcare-act

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Digital health apps and telemedicine in England and Wales

(1 days ago) WEBSoftware in the form of digital health apps may be considered a “medical device.”. In this post-Brexit period, medical devices placed in the “Great Britain market” (England, Wales …

https://cms.law/en/int/expert-guides/cms-expert-guide-to-digital-health-apps-and-telemedicine/england-and-wales

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The Benefits of AI in Healthcare IBM

(7 days ago) WEBThe World Health Organization (WHO) spent 18 months deliberating with leading experts in ethics, digital technology, law, and human rights and various …

https://www.ibm.com/think/insights/ai-healthcare-benefits

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Low-intensity digital mental health service promised in federal …

(8 days ago) WEBThe federal government says it will spend $588 million over eight years to set up a "low intensity digital mental health service", which the government says will be …

https://www.abc.net.au/news/2024-05-16/digital-mental-health-services-falls-short-say-psych-groups/103852996

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Euro Convergence: Experts concerned about incompatibilities …

(Just Now) WEBBERLIN @ Experts are concerned that the recently adopted European Artificial Intelligence (AI) Act is in some ways incompatible with the Medical Device Regulation …

https://www.raps.org/News-and-Articles/News-Articles/2024/5/Euro-Convergence-Experts-concerned-about-incompati

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TikTok Sues U.S. Government Over Law Forcing Sale or Ban

(6 days ago) WEBTikTok sued the federal government on Tuesday over a new law that would force its Chinese owner, ByteDance, to sell the popular social media app or face a ban …

https://www.nytimes.com/2024/05/07/business/tiktok-ban-appeal.html

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Biden to debate Trump: Here's what the candidates may spar about

(1 days ago) WEBAs president, Trump signed legislation to increase funding for substance use disorder treatment in the wake of the opioid epidemic. In 2017, he declared the opioid …

https://www.usatoday.com/story/news/politics/elections/2024/05/17/biden-trump-debate-topics-immigration-economy-israel/73714179007/

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Digital Health Laws and Regulations Report 2024 India

(3 days ago) WEBThe digital health industry in India is expected to increase from $3.83 billion in 2022 to $18.34 billion by 2030, at a CAGR of 21.6% between 2022 and 2030. …

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

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TikTok Sues US Over Divest-or-Ban Law, Alleging It Is - Variety

(3 days ago) WEBAs expected, TikTok filed a federal lawsuit seeking to overturn the U.S.’s new law that would force Chinese parent company ByteDance to sell the app — or face a …

https://variety.com/2024/digital/news/tiktok-sues-us-law-ban-app-unconstitutional-1235994443/

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