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Strategies to Unlock AI's Potential in Health Care, Part 4: How and When Will Congress Act?
… role in regulating the advancing field; for example, the 21st Century Cures Act (which our colleagues previously discussed here ). …
Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities
… working to implement regulatory changes required by the 21st Century Cures Act, which was enacted in December 2016. A proposed …
Senate HELP Committee Convenes Third and Final Cures Markup
… Senate HELP Committee Convenes Third and Final Cures Markup This morning the Senate Committee on Health, … package. This package is a compliment to the House-passed 21st Century Cures Act, which the House passed in July of 2015. …
Health Care Update & Telehealth Policy Alert
… the Medicare program to providers of telehealth services. 21st Century Cures Initiative: On the House side, the Energy and Commerce …
FDA Introducing a Variety of Programs to Help Medical Devices Get to Market
… visible, such as the Breakthrough Devices program in the 21st Century Cures Act and the Software Precertification pilot program in …
ML Strategies Publishes Washington Outlook for 2016
… on a number of initiatives we have been following in 2015: 21st Century Cures Act Senate Chronic Care Initiative Mental Health …
Health Care Congressional Outlook for the June Work Period
… bills, and work on that is expected to resume this week. 21st Century Cures The Senate’s version of the 21st Century Cures Act has …
This Week’s ML Strategies Health Care Update: Big Changes (Possibly) Ahead for Drug Manufacturers
… also expressed interest in this issue when it passed the 21st Century Cures Act. The Amarin Pharma decision is another significant …
ML Strategies Health Care Congressional Outlook
… this summer. The Senate continues its work on the 21 st Century Cures Act , but funding issues continue to hamper progress. … preview, please click here . June 08, 2016 Blog Health Care 21st Century Cures Health Care Congressional Outlook mental …
Information Blocking Rule: Key Considerations for 2022
… for Health Information Technology (ONC) issued the 21st Century Cures Act; Interoperability, Information Blocking, and the …
Next Steps for 21st Century Cures 2.0
… Next Steps for 21st Century Cures 2.0 On Monday, April 27, Representatives Diana DeGette … that will build on the original 21st Century Cures Act enacted in December 2016 (Cures 1.0). While Cures 1.0 …
CMS's Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic
… to substance use disorders, as required by the 21 st Century Cures Act. CMS proposed renaming HCC 55 to be “Drug/Alcohol …
Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier
… of health information security and ratcheted up the fear factor associated with its HIPAA Breach Reporting Tool … the nation’s current opioid crisis and implement the 21 st Century Cures Act. These tools support critical federal policy …
Evolution & Revolution: Device Policy Priorities at FDA in 2019
… clinical laboratories; laboratory developed tests; VALID Act; IVCT; in vitro clinical tests; 510(k) modification; …
FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm
… Act to the biomedical innovation package contained in the 21st Century Cures Act (H.R. 6), which was passed by the House in July of …
OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement
… it also highlights OIG’s work that has yet to result in any action. The OIG portfolio contains five substantive … an ASP-based methodology, implemented through the 21 st Century Cures Act. The Recommendations section lists ten specific …
CMS’s Draft 2018 Call Letter: Minor Updates, but Largely a Continuation of Current Policies
… Program.” Of note, CMS is also determining whether the 21st Century Cures Act may impact the pricing. 2018 Star Rating Updates …
Flash: What the Election Means for Health Care
… in lame duck: There are two major outstanding issues, the 21st Century CURES Act and mental health legislation. Republicans will …
Privacy and Security Round-up – Colorado Data Breach Law, Guidance from OCR
… or military identification number; or a financial transaction device. In addition, the law requires entities to … for future research. The guidance was mandated by the 21 st Century Cures Act, which required HHS to issue clarifications on how …
ML Strategies Provides Outlooks for Fall & Lame Duck
… remains unchanged. The Senate version of the House-passed Cures package is still in limbo, and mental health reform is … mental health package, there is momentum behind the effort. 21st Century Cures : While securing passage this summer for the …