MRO Compliance

MAY 2, 2022

Back in May of 2002, I founded MRO with two colleagues to meet the evolving needs of document and disclosure management services for the healthcare industry. Quality assurance, while still important back in 2002, had to be done manually by having an employee physically check each record that was going to be released.

Hospitals 130

Hospitals 130

Health Care Law Brief

APRIL 11, 2022

As early as 2002 and as highlighted in recent guidance , OIG has explained its longstanding concerns relating to the offering of incentives intended to induce beneficiaries to obtain federally reimbursable items and services when those incentives have been cash or cash equivalents. at 77790, 77791.

Fraud 52

Fraud Medicare Medicare Compliance 52

SQA

FEBRUARY 22, 2021

Compliance with UDI requirements will now be enforced for the first batch of devices in the agency’s phased implementation plan. Since the introduction of the exemption in 2002, the technology and manufacturing processes used to produce medical devices have changed dramatically.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

American Medical Compliance

MARCH 4, 2024

Get Certified American Medical Compliance (AMC) is a leader in the industry for compliance, Billing, and HR solutions. To become certified, please visit us at: American Medical Compliance (AMC). Also, OSHA stated in 2002 that although this type of care may occur often, it is not required to be reported.

Compliance 52

Compliance 52

HIPAA Journal

APRIL 26, 2022

The Administrative Simplification provisions led to the publication of the HIPAA Privacy and Security Rules which were enacted in 2002 and 2003 respectively. HITECH introduced the HIPAA Breach Notification Rule and new compliance requirements for both Covered Entities and their Business Associates.

HIPAA 65

HIPAA Compliance 65

SQA

JULY 8, 2022

The review has two purposes: To ensure devices included in the ARTG continue to meet the essential principles set out in the Therapeutic Goods (Medical Devices) Regulations 2002. To confirm these devices remain safe for use, by checking if they are made using PE-PUR foam or any other potentially harmful soundproofing material.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

DECEMBER 16, 2022

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. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Good Practice Guide: Membrane Based WFI Systems, May 2002. ISPE Good Practice Guide: Critical Utilities GMP Compliance. Affected needle kits should be destroyed in compliance with the health care institution’s process for disposal.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

Health Law Advisor

APRIL 26, 2023

While multi-state providers often have modified compliance programs for each state or territory, it is unlikely that even the most sophisticated provider would be able to develop the internal and technology systems necessary to permit ordering the drug in states subjected to different REMS with accompanying manufacturer and supplier requirements.

FDA 97

FDA Hospitals Governance Compliance 97

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The Therapeutic Goods (Medical Devices) Regulations 2002 now includes for Essential Principle 7.7:

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

AUGUST 10, 2023

FDA came out with guidance explicitly explaining its reach over hospitals engaged in those reprocessing efforts, [14] and in 2002 Congress validated that extension with an amendment to the underlying statute. [15] 15] Medical Device User Fee and Modernization Act of 2002, Report 107-728 (Oct. 7, 2002), at 21. [16] 13] [link]. [14]

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

AUGUST 2, 2021

ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. ISO5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

HIPAA Journal

DECEMBER 14, 2022

The compliance date for the CMS rule was July 1, 2021. HIPAA-covered entities are then given a grace period to make the necessary changes before compliance with the new HIPAA regulations becomes mandatory and the HIPAA changes become enforceable. The HITECH Act called for an increase in penalties for non-compliance with the HIPAA.

HIPAA 124

HIPAA COVID-19 COVID-19 Vaccine Compliance 124

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

AUGUST 28, 2023

If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened. 435, 436 (2002). Linda Greenhouse, “Thinking About the Supreme Court After Bush v. Gore ,” 35 Ind.

FDA 52

FDA Doctors Malpractice COVID-19 52

Drug & Device Law

SEPTEMBER 11, 2023

If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened. 435, 436 (2002). Linda Greenhouse, “Thinking About the Supreme Court After Bush v. Gore ,” 35 Ind.

FDA 59

FDA Doctors Malpractice COVID-19 59

Drug & Device Law

JULY 31, 2023

2002), held that a videogame could not be a “product” for strict liability purposes. “[I]n considering whether to recognize a new tort recovery theory, the Colorado courts give great weight to the theory’s impact on free expression.” Connecticut Connecticut’s products liability statute does not define the term “product.” See Conn.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JANUARY 30, 2023

American Honda Motor Co. , Moran , 536 U.S. Moran , 536 U.S. Walsh , 538 U.S. Dow Agrosciences LLC , 544 U.S. Learjet, Inc. , Liberty Mutual Insurance Co. ,

FDA 72

FDA Fraud Governance Medicare 72