Symplr

SEPTEMBER 18, 2023

In 2004, President Bush set a goal for every American to have an electronic health record (EHR) by 2014. The goal was that better and safer care could be delivered through more complete knowledge of a patient that was accessible in a secure repository.

Licensing 52

Licensing Compliance Hospitals 52

Healthcare Compliance Blog

MARCH 31, 2022

The New York Wage Parity Act, Public Health Law sets minimum wage and benefit requirements for licensed home care services agencies (LHCSAs) that employ home care aides who render services to Medicaid recipients in New York City and three counties in New York. million to New York State for conduct between 2014–2017.

Medicaid 59

Medicaid Medicaid Governance Fraud 59

Natalia Mazina

JANUARY 26, 2023

From May 2014 to at least February 2016, Fusion Rx received approximately $14 million in reimbursements on its claims for compounded drug prescriptions. The pharmacy owner, who also acted as the pharmacist-in-charge, had his license revoked by the California State Board of Pharmacy.

Governance 52

Governance Licensing Compliance 52

Compliancy Group

JANUARY 20, 2022

Let’s Simplify Compliance Learn how to protect your business from breaches in our upcoming webinar! In 2014 Kiteworks was launched as a successor to FTA. Most customers had migrated to the new software by early 2020, and the company was no longer selling new licenses for the FTA product. .

Licensing 52

Licensing Compliance HIPAA Governance 52

HIPAA Journal

DECEMBER 24, 2022

OCR prefers to resolve HIPAA violations using non-punitive measures, such as voluntary compliance or issuing technical guidance to help covered entities address areas of non-compliance. Penalties for Non-Compliance with HIPAA. Financial penalties for HIPAA violations have frequently been issued for risk assessment failures.

HIPAA 122

HIPAA Compliance Hospitals COVID-19 122

HIT Consultant

MARCH 3, 2022

Clinical trial teams face a multitude of competing priorities, from evaluating hundreds of potential patients to maintaining compliance and recording patient progress. Seamless retrieval of accurate trial documentation is possible with support automation, and it’s essential to a clinical study’s safety, compliance and success.

Compliance 52

Compliance Licensing 52

HIPAA Journal

FEBRUARY 17, 2023

HIPAA Journal is conducting interviews with healthcare professionals, compliance professionals, and industry service providers to find out more about how their experiences with HIPAA, their successes, and the challenges they have and continue to face with HIPAA compliance. When did you first get involved with HIPAA compliance?

HIPAA 52

HIPAA Compliance Licensing Hospitals 52

Healthcare Law Blog

MAY 16, 2022

At the beginning of the applicable contract year, the credit and the use of LOIs will no longer apply and, if the application is approved, the MAO must be in full compliance with network adequacy, including having signed provider and facility contracts. A warning letter = 3 points. A notice of noncompliance = 1 point.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Bill of Health

OCTOBER 28, 2024

is a licensed marriage and family therapist, researcher, and bioethicist. She has a Bachelor’s degree from Smith College in history and African studies, where the college awarded her Outstanding Student Leader of the Year in 2014. Harrison M.A., She currently lives in New York City. Callie Hoffmann , J.D.,

Bioethics 113

Bioethics Licensing Regulatory Compliance Hospitals 113

Bill of Health

MAY 28, 2024

The process of rescheduling may be long and is unlikely to create a pathway to federal compliance for state-legal marijuana businesses without further federal legislation. Since 2014, Congress has passed spending amendments that limit the use of federal funds for enforcement against state-compliant medical marijuana programs.

FDA 214

FDA Bioethics Compliance Telemedicine 214

Health Law Advisor

AUGUST 10, 2023

FDA specifically identified the following as not having to register as device manufacturers: Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. [8] 8] We could go on, but hopefully you get the gist.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

SEPTEMBER 2, 2022

ISPE Good Practice Guide: Critical Utilities GMP Compliance. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. Affected needle kits should be destroyed in compliance with the health care institution’s process for disposal.

FDA 91

FDA COVID-19 Nursing Homes Public Health 91

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. 26 of 2014. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). 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.

COVID-19 52

COVID-19 FDA COVID-19 Vaccine Compliance 52

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 name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

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 written procedure for recall was inadequate and this procedure had not been implemented.

FDA 40

FDA Licensing Governance Compliance 40

Healthcare Law Blog

JANUARY 10, 2022

While acknowledging the sufficiency of its current practice of triennial reviews of MAOs’ provider networks for compliance with network adequacy requirements, CMS believes that a return to reviewing applicants’ provider networks will help ensure overall bid integrity, result in improved product offerings, and protect beneficiaries.

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

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. The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

FEBRUARY 26, 2024

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices,were verifiedon the spot.

FDA 40

FDA Compliance COVID-19 Public Health 40

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 40

FDA Compliance Public Health Governance 40

Drug & Device Law

JULY 31, 2023

2014 WL 46696, at *5 (C.D. 3, 2014) (claim dismissed absent any “facts to support that Defendant’s software includes physical items or is a tangible product”); Windsor Auctions, Inc. 2014 WL 1247768, at *3 (E.D. March 25, 2014); Torres v. 2014) (plaintiff’s “theory is that [defendant’s] software program. . .

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

OCTOBER 27, 2022

2014); accord, e.g. , Dougherty v. From this, the court concluded the defendants could “comply with both federal and Illinois law by obtaining proof of identity and establishing a donor identification system using photographic identification, a valid driver’s license, or any other non-biometric means.” 3d 467, 477 (E.D.

FDA 59

FDA Licensing Compliance 59