| Mintz

Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry

… of the changes in 2017 were prompted by the passage of the 21st Century Cures Act, which exempted certain software products from the …

CMS Proposes Changes to Medicare’s Coverage Determination Criteria and Expedites Approval of Breakthrough Devices

… FDA. FDA’s Breakthrough Devices Program is a product of the 21st Century Cures Act. The program is intended to expedite the …

HIPAA and Health Care Data Privacy - 2018 Year-in-Review

… disclosure of PHI for future research , as mandated by the 21st Century Cures Act. In October, OCR and the HHS Office of the …

Health Care Enforcement Review and 2017 Outlook: FDA's Wide-Ranging Activities

… for the product. Finally, in December, Congress passed the 21st Century Cures Act, which mandated various changes to drug and device …

Senate Finance Committee Passes Drug Pricing Bill

… (HOPDs) under the Bipartisan Budget Act of 2015 and the 21st Century Cures Act of 2005. As a result, beginning January 1, 2021, …

FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”

… and speaking about the myriad provisions of the 21 st Century Cures Act. This wide-ranging law has many mandates for agency …

Kate F. Stewart

… Online Event Speaker Feb 2 2017 Part II: The Impact of Cures on Clinical Research Webinar Tracking Technologies in … in gross cash proceeds. Briefings on HIPAA: Inside the 21st Century ONC Cures Act November 1, 2021 Mintz Of Counsel Kate …

Looking Ahead: FDA in 2021

… into a broader regulatory reform legislative package like 21st Century Cures 2.0. Cures 2.0 could also bring renewed focus on the …

Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities

… (RMAT) designation program created with passage of the 21st Century Cures Act. The first final guidance, Expedited Programs for …

The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?

… device based on the specific exemptions created by the 21st Century Cures Act (see our previous posts on the Cures Act and CDS …

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

… FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership As is the tradition here at Health Law … important (and bipartisan!) legislation – the 21 st Century Cures Act (see our prior posts here ) – which …

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity Technology and Electronic Health Records

… few legal avenues to prevent information blocking, but the 21st Century Cures Act has now given ONC and OIG more direct authority to …

Regulatory Roundup: Important FDA Developments at the End of September 2022

… and other stakeholders since well before passage of the Cures Act in 2016, in part due to the increasing complexity … final guidance focuses solely on the interpretation of the 21st Century Cures Act language that exempts some types of CDS …

Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

… changing ways that people purchase and consume food in the 21st century. On the enforcement side of the FDA’s diverse and … mandated by Congress in the now-five-year-old 21st Century Cures Act , releasing four draft guidances (see here , here …

FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic Modernization, and Expansion of Certain Existing Programs

… information safe harbor in December 2016 as part of the 21st Century Cures Act (which we blogged about at the time here ); and …

FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round

… a similar program into law for medical devices in the 2016 21st Century Cures Act.) At the same time, however, PDUFA VI has some …

Ellen L. Janos

… Webinar Speaker Jan 12 2017 Part I: Introduction to the 21st Century Cures Act Webinar Panelist Jun 22 2016 The Promise of …

ML Strategies COVID-19 Insights Week In Review — May 1, 2020

… Chain Negotiations Underway on Additional Stimulus Measures 21st Century Cures 2.0 Senators Seek Phase 4 Stimulus Provisions for …

The Future of the Affordable Care Act Week 7: The American Health Care Act

… small employer health reimbursement arrangement” under the 21st Century Cures Act. Employer Reporting The bill also makes …

Health Information Privacy & Security

… & Restructuring California Land Use Cannabis Class Action Complex Commercial Litigation Construction Consumer … and Corporate Governance (ESG) FDA Regulatory False Claims Act Federal Circuit Appeals Financial Institution Litigation … Health Care Enforcement & Investigations Health Care Transactions Health Information Privacy & Security IP Due …