| Mintz

Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation

… Congress liked what FDA was doing so much that in the 21st Century Cures Act certain software functionality was deleted from …

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

… blocking definition in the implementing regulations for the 21st Century Cures Act, which sets forth a knowledge standard such that a …

ONC Publishes Report, Commentary on Information Blocking Rule Claims Trends

… in the Information Blocking Final Rule involved. While the 21st Century Cures Act (Cures Act) allows OIG to investigate any …

What to Expect at FDA Following Commissioner Gottlieb's Departure

… the past few years to set the FDA’s agenda by passing the 21st Century Cures Act and other laws that include programmatic and …

CMS Proposes Changes to Medicare Advantage Program for CY 2020

… misuse. Risk Adjustment Payments By way of background, the 21st Century Cures Act requires CMS to update the risk adjustment model …

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 …

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 …