| Mintz

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 In the revised CDS draft guidance …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 …

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 …