HIPAA Journal

JULY 15, 2023

We have compiled these HIPAA Compliance Guidelines because HIPAA rules and regulations can be very confusing for healthcare professionals tasked with ensuring HIPAA compliance at their organization. We have slightly amended it to be more relevant to HIPAA compliance in 2023. Designate a Privacy Officer and a Security Officer.

HIPAA 80

HIPAA Compliance Compliance Officers Licensing 80

Healthcare Law Blog

JANUARY 26, 2023

The 2011 Final Rule On February 23, 2011, HHS issued the final rule entitled “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws” (the “ 2011 Final Rule ”). The 2019 Final Rule was therefore vacated in its entirety and HHS has been operating under the 2011 Final Rule since its adoption.

ACA 105

ACA Medicaid Medicaid Compliance 105

Innovaare Compliance

JANUARY 15, 2024

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. With a team of compliance specialists, Inovaare provides in-depth technical expertise and compliance preparedness evaluation, guidance, and support.

Medicare 52

Medicare Medicare Compliance FDA 52

Verisys

JULY 13, 2023

How to Tackle Pharma’s 3 Biggest Compliance Risks Head-On with Verisys How often have you started at a new organization and heard these phrases? “ Some companies make decisions based on compliance standards and optics, while others may be more lax. Clinical trial compliance can offer unique challenges for pharmaceutical companies.

Compliance 52

Compliance Due Diligence Pharmaceutical Industry Fraud 52

SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services 40

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

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