Health Care Law Brief

JULY 25, 2023

The Final Rule codifies the prohibition on “information blocking” introduced by the 21st Century Cures Act (“ Act ”), which was enacted on December 13, 2016. 1033, (2016); 42 U.S.C. Department of Health and Human Services (“ HHS ”) released its final rule (“ Final Rule ”) implementing penalties for information blocking. See also U.S.

HIPAA 52

HIPAA Payment Systems Compliance Licensing 52

Bill of Health

OCTOBER 31, 2024

government has discussed the potential adoption of a uniform FOP label, with Congress directing the Centers for Disease Control and Prevention and Institute of Medicine (IOM) to produce recommendations on the topic. In 2016, Chile was the first country to implement mandatory FOP warning labels. Since 2009, the U.S.

Public Health 100

Public Health FDA Governance Licensing 100

Bill of Health

OCTOBER 28, 2024

is a licensed marriage and family therapist, researcher, and bioethicist. Ifetayo’s experience growing up with her father in prison brought her to drug policy reform work in 2013 as an intern at the Drug Policy Alliance (DPA) and then joined them full-time in 2016. Harrison M.A., William Leonard Pickard M.P.P.,

Bioethics 114

Bioethics Licensing Regulatory Compliance Hospitals 114

Healthcare Compliance Blog

APRIL 19, 2022

The events took place between January 2016 through March 11, 2019, during which time the man claimed to be a licensed physician in the state of Mississippi. He was not licensed to practice medicine in Mississippi or in any other state. He was also ordered to pay restitution of $1,537,326.14

Licensing 59

Licensing Medicare Medicare Governance 59

Health Law Advisor

AUGUST 10, 2023

2] Implementing the 21st Century Cures Act from 2016, regulated CDS software includes that intended to “analyze” “medical information about a patient or other medical information” “for the purpose of supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.”

FDA 98

FDA Licensing Hospitals Medicaid 98

Health Populi

APRIL 12, 2024

S 2016) and second, re-introduce and sign the Telehealth Modernization Act. Plainly put, we have 20 th Century laws governing 21 st century health care delivery. This, to assure the physician that he would not be tracked by the sort of FBI state licensing compact concerns described in the linked article above.

Doctors 83

Doctors Licensing Hospitals Governance 83

HIT Consultant

OCTOBER 4, 2024

Legal Compliance: Intricate laws and regulations govern patient care, labor relations, and healthcare operations. They screen for the best and select only certified, licensed, and well-trained nurses capable of performing immediately and effectively during a strike. About Trevor Fandale Trevor Fandale is the President of Huffmaster.

Nurses 98

Nurses Compliance Hospitals Licensing 98

MedTrainer

NOVEMBER 29, 2023

The Board of Registration in Medicine (BORIM) for Massachusetts is the regulatory body responsible for licensing, monitoring, and disciplining physicians in the state to ensure the highest standards of medical practice and patient care. This article reveals the must-knows for confidently achieving compliance in Massachusetts.

Compliance 52

Compliance Public Health Health Insurance Hospitals 52

Kaiser Health News

APRIL 6, 2022

About 30% of its funding comes from government grants and contracts. Since graduating in 2016, Weston has worked in development for Hope Connection International , a nonprofit his mother started to support survivors of abuse and addiction. Only 12 facilities are licensed to prescribe buprenorphine.

Licensing 92

Licensing Public Health FDA Doctors 92

Provider Trust

OCTOBER 12, 2021

License verification, especially nursing license verification, is essential to ensuring that only the most qualified practitioners are seeing your patients. Additionally, of all licensed RNs, 84.5% Additionally, of all licensed RNs, 84.5% License Verification Is Incredibly Complex. with more than 3.8

Licensing 52

Licensing Nurses COVID-19 Public Health 52

Bill of Health

SEPTEMBER 29, 2022

” While the wording of the rules have not changed, the recent USPTO notice explicitly brings all kinds of new materials within the ambit of the disclosure requirement, including: Conflicting statements made to other Government agencies (e.g., MPEP § 2016. The Duty of Reasonable Inquiry.

FDA 130

FDA Governance Fraud Licensing 130

Healthcare Law Blog

JANUARY 5, 2023

Similarly, CMS proposes to revise § 422.2267(e)(12) to specify requirements for the content of the notification to enrollees about a provider contract termination, to codify best practices that have been in CMS guidance since 2016. The Proposed Rule specifies the applicable refund methods (e.g., lump sum, premium reduction, etc.)

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in color and typeface and uses the BTNX Inc. device identifier “COV-19C25.”

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Bill of Health

SEPTEMBER 22, 2024

A rare victory for the government, announced at the end of the 2023 Supreme Court term, may signal a modest retreat from the Court’s 2022 holding that historical antecedents are the sole dictator of constitutionality.

Public Health 204

Public Health Governance Licensing 204

Hall Render

FEBRUARY 10, 2023

Dunleavy proposes extending Medicaid coverage for new mothers ARIZONA Banner Health pays $1.25M penalty over HIPAA failures from 2016 breach Arizona nursing school at risk of losing accreditation St. billion since pandemic U.S. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Hall Render

NOVEMBER 17, 2023

Jill Biden will lead new initiative to boost federal government research into women’s health Joint Commission says acute, critical access hospitals must join safety network Lawsuit claims UnitedHealth AI wrongfully denies elderly extended care Most Rural U.S. Compensation is key Is spine surgery expansion next for ASCs? Many more are waiting.

Nursing Homes 40

Nursing Homes Nurses Hospitals Doctors 40

Bill of Health

APRIL 16, 2025

Inside one of the most-fined nursing homes in Mass But if the federal government wont require minimum staffing standards, states can. If the federal government returns to the toothless per instance fines for inadequate care adopted by the first Trump Administration, states can impose their own, meatier penalties. Some already do.

Nursing Homes 242

Nursing Homes Nurses Licensing COVID-19 242

Healthcare Law Blog

JUNE 15, 2023

In their motion for preliminary injunction to withdraw or suspend the FDA approvals of chemical abortion drugs, the Texas Plaintiffs claim that the FDA is “running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs.” Fifth Circuit Order, at 2.

FDA 52

FDA Governance Telemedicine Licensing 52

Bill of Health

MARCH 28, 2023

government had funded the R&D for each of the three patented inventions that are currently blocking generic competition. government has a “paid-up license to practice or have practiced for or on behalf of the United States” the invention “throughout the world” ( 35 U.S.C. Also, aside from its “paid-up license,” the U.S.

Licensing 265

Licensing Governance Medicare Medicare 265

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether. Polansky v. UnitedHealthcare, Inc. ,

FDA 105

FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

SEPTEMBER 7, 2023

Defendants contended that anything about abortion was a “major question” that had to be decided by Congress rather than FDA and abortion was not mentioned in the FDCA, FDAAA, or other acts governing FDA. 115 (2016), eight years after Levine , there is no such presumption in express preemption either. emphasis in original).

FDA 59

FDA Licensing Telemedicine Governance 59

Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 2016) (citations omitted). 2016) (citation and quotation marks omitted). ADT, LLC , 2016 WL 3208483, at *3 (N.D. June 10, 2016); GCube Insurance Services., at 1291-92. at 1293-94.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. In 2016 (during the Obama Administration), the FDA amended this REMS, “expanding those who could be certified to prescribe. . . Sorsaia , C.A.

FDA 111

FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. at 183 (quoting Meyers v. Donnatacci , 531 A.2d

Doctors 52

Doctors Fraud Licensing Compliance 52