| Mintz

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 …

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 …

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 …

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 …

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 …

Evolution & Revolution: Device Policy Priorities at FDA in 2019

… types of CDS were exempted from FDA oversight in the 2016 21st Century Cures Act (Cures Act). In the revised CDS draft guidance …

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 …

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 …