AIHC

JUNE 6, 2023

OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. This is certainly an area where advanced technology is needed to reduce overhead, improve compliance and reduce billing errors.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Hall Render

JULY 14, 2023

On June 7, 2023, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first Untitled Letter of the year regarding violative promotional materials for a prescription drug indicated for the treatment of endogenous hypercortisolemia (high cortisol) in adults with Cushing’s syndrome.

FDA 40

FDA Compliance 40

SQA

FEBRUARY 15, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023. The ongoing training of personnel was inadequate.

US Department of Health and Human Services 40

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

YouCompli

MARCH 29, 2023

CMS Updates to beneficiary PHE waivers that matter to healthcare compliance Sharon Parsley, JD, MBA, CHC, CHRC, contributes regularly to the YouCompli blog. As a result, the COVID-19 public health emergency (PHE) declared under Section 319 of the Public Health Service act, is expected to end officially on May 11, 2023.

Public Health 52

Public Health COVID-19 COVID-19 Vaccine Medicare 52

Innovaare Compliance

JANUARY 15, 2024

This blog delves into the details of these changes and their implications for plan sponsors and beneficiaries. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. Non-applicable drugs (i.e.,

Medicare 52

Medicare Medicare Compliance FDA 52

SQA

AUGUST 8, 2023

The new standard, RDC 786/2023 , was published in the Official Gazette on 10 May 2023 and will enter into force on 01 August 2023, but establishments will have up to 180 days to comply with the updated rules. The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products.

FDA 40

FDA Compliance Licensing World Health 40

SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

FDA 40

FDA Licensing Governance Compliance 40

SQA

JUNE 10, 2021

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda. As such, manufacturers and importers that have already submitted their applications to CDSCO may continue marketing their devices in India as they prepare for compliance.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Healthcare Law Blog

MAY 11, 2023

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain preventative screening tests (the “Arrangement”). FOOTNOTES [1] 42 U.S.C. 1320a–7b(b). [2] 2] 42 U.S.C.

Medicare 52

Medicare Medicare Fraud Compliance 52

Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

FDA 40

FDA Public Health Compliance Hospitals 40

SQA

APRIL 12, 2023

SQA Regulatory Surveillance Summary for February 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Releases the Results of the 2022 Strategy, 31 January 2023 The ANVISA Strategy Performance and Results Evaluation Report is now available for consultation, for the year 2022.

FDA 40

FDA Compliance Pharmaceutical Industry 40

Hall Render

MARCH 29, 2023

It is hard to believe that spring is finally here and the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has yet to take any enforcement action in 2023. Untitled Letters allow a company to correct the violations without any further FDA action.

FDA 40

FDA COVID-19 Compliance 40

SQA

DECEMBER 16, 2022

The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of 01 March 2023. China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

effective as of 01 July 2023. ISPE Good Practice Guide: Critical Utilities GMP Compliance. United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. The European Pharmacopoeia (Ph. Supplement 11.2,

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

DECEMBER 10, 2021

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. UDI compliance lead times for manufacturers will depend on the risk classification of their devices: Two years for Class IV (highest risk) devices. By Laurel Hacche & Debra Cortner SQA Associates. European Commission (EC).

FDA 52

FDA Compliance Public Health Hospitals 52

Healthcare Law Blog

OCTOBER 25, 2023

iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act. What Do Pharmaceutical Manufacturers Need to Do?

Licensing 52

Licensing Compliance FDA Public Health 52

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

OCTOBER 18, 2022

The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up. After this date, the CAP’s compliance team will remove non-compliant ads using targeted software, and those who continue to promote it may be referred to the MHRA for further enforcement action. Health Advance Inc.

US Department of Health and Human Services 40

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

Healthcare Law Blog

AUGUST 25, 2022

The drug publication date for 2026 will be chosen by September 1, 2023. Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. Program Compliance. Negotiation-Eligible Drugs. Penalties under the Program are severe.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

FEBRUARY 26, 2024

The action was held from 26 to 28 September 2023, at the city’s international entry points. ANVISA Publishes New Measures to Prohibit Cosmetic Products Used in Injectable Form, 10 October 2023 ANVISA published two resolutions that suspended the trade, distribution, manufacture, advertising, and use of products from PHD Cosméticos Ltda.

FDA 52

FDA Compliance COVID-19 Public Health 52

Healthcare Law Blog

NOVEMBER 13, 2023

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). This proposal would shift the burden from CMS to the MA organization to demonstrate compliance with this standard.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

FDA 105

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

Drug & Device Law

APRIL 21, 2023

84075, 2023 WL 2779206 (Nev. 4, 2023), and while the opinion does not disclose whether the implants were 3D printed, the opinion raises all the same questions. The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information).

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59

Drug & Device Law

JANUARY 23, 2023

2023 WL 239395 (D.N.J. Jan 18, 2023), the plaintiff was implanted with the defendant’s textured breast implant after undergoing a mastectomy. D’Addario , 2023 WL 239395 at *4 (internal punctuation and citation to Riegel omitted). In D’Addario v. Johnson & Johnson , et al., In other words, “where a.

FDA 111

FDA Fraud Doctors Governance 111

Drug & Device Law

JUNE 5, 2023

2023 WL 2565853 (N.D. March 17, 2023), reconsideration denied , 2023 WL 3032063 (N.D. Kelley was actually decided a couple of months ago, but due to Reed Smith’s involvement in the case, we could not blog about it until the matter recently settled. 2023 WL 3032063, at *2 (N.D. citation omitted). footnote omitted).

FDA 59

FDA Regulatory Compliance Compliance Fraud 59