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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 …
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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 …
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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, …
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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 …
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A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA
… through recent amendments to the FD&C Act – such as in the 21st Century Cures Act from 2016 and the Food and Drug Omnibus Reform Act …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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Health Care Privacy and Security in 2024: Six Critical Topics to Watch
… one of the various information blocking provisions of the 21st Century Cures Act (Cures Act) and in addition to “disincentives,” it …
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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 …
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Medicare, Medicaid and Commercial Coverage & Reimbursement
… Licensing & Certification Healthcare: Affordable Care Act Healthcare: Biosimilars Healthcare: Centers for Medicare … Hospitals & Health Systems Healthcare: Inflation Reduction Act Healthcare: IRA Update Healthcare: Legislation … Pharmacies Healthcare: Physicians Healthcare: Sunshine Act Healthcare: Telemedicine Healthcare: Value-Based Care …
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Digital Health
… States Follow Suit? June 10, 2020 | Blog | Next Steps for 21st Century Cures 2.0 May 8, 2020 | Blog | Telehealth Reimbursement …
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Washington Outlook for 2016
… plate this year include a response to the outcome of the 21st Conference of Parties to the United Nations Framework … achieving carbon neutrality by the second half of the century; adapting to adverse climate impacts and fostering … passage of its version of the House-passed 21st Century Cures Act, enacting legislation around the Senate chronic …