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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Ropes & Gray LLP's Digital Health Practice Group ordered by Published Date Descending.
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Aiming To Foster Innovation, FDA Proposes Regulatory Framework Specific To Prescription Drug Software
As such, the software output would be subject to FDA's regulations for FDA required labeling or promotional labeling, as applicable.
United States
5 Dec 2018
2
FDA Issues Draft Guidance On Devices With Multiple Functions
On April 27, 2018, FDA issued draft guidance on the regulation of devices with multiple functions.
United States
15 May 2018
3
FDA Issues Draft Guidances To Scale Back Regulation Of Digital Health Software
These developments continue to build on the policies FDA has been developing in recent years to clarify the applicability of FDA regulatory requirements to digital health technologies.
United States
14 Dec 2017
4
FDA Announces New Digital Health Innovation Programs
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the FDA has announced new plans to streamline the development and availability of high quality digital health products.
United States
31 Jul 2017
5
FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework
In his first public statement as Commissioner of the Food and Drug Administration ("FDA") on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes.
United States
26 Jun 2017
6
FDA Finalizes Guidance On Postmarket Management Of Medical Device Cybersecurity
On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices.
United States
19 Jan 2017
7
21st Century Cures Act – Provisions To Promote Drug Development
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
8
21st Century Cures Act – Provisions Relating To Digital Health
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
9
21st Century Cures Act – Provisions Relating To Reimbursement & Fraud And Abuse
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
10
21st Century Cures Act – Provisions Relating To Development Incentives For Certain Classes Of Drugs
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
14 Dec 2016
11
FDA Issues Final Guidance on General Wellness Products
On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate "general wellness products," including software applications, ..
United States
4 Aug 2016
12
Health Apps And HIPAA: OCR Publishes New Privacy Guidance For Health App Developers
On February 11, 2016, in response to requests from developers of mobile health applications, the Department of Health and Human Services Office for Civil Rights released a new guidance document addressing the applicability of HIPAA to applications that collect, store or transmit health information.
United States
22 Feb 2016
14
CMS And ONC Issue Final Rules For EHR Advancement
On October 6, 2015, the U.S. Department of Human Health and Services ("HHS") released two final rules related to the Medicare and Medicaid Electronic Health Record Incentive Programs.
United States
23 Oct 2015
15
21st Century Cures Act – Provisions Relating To Digital Health: Interoperability And Information Blocking
On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the "bill") by a vote of 344-77.
United States
24 Jul 2015
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