HIPAA Journal

AUGUST 16, 2022

Intermedix Corporation worked with Lee County Emergency Medical Services for almost 15 years, with the contract terminating in September 2014. Lee County Emergency Medical Services has recently started notifying certain patients about a business associate-related data breach.

Ransomware 100

Ransomware HIPAA Licensing Governance 100

HIT Consultant

SEPTEMBER 19, 2021

According to CRICO’s national CBS Database, 66% of malpractice cases in telemedicine from 2014 to 2018 were connected to misdiagnosis. Particularly the certification and license are one of the main challenges for nurses in telemedicine. Government cooperation. Pandemic allowed those who were hesitant to try out telemedicine.

Telemedicine 98

Telemedicine Licensing Nurses HIPAA 98

Compliancy Group

JANUARY 20, 2022

The breaches affected federal, state, local, tribal, and territorial government organizations as well as private industry organizations in the medical, legal, telecommunications, finance, and energy fields around the world. . In 2014 Kiteworks was launched as a successor to FTA.

Licensing 52

Licensing Compliance HIPAA Governance 52

Compliancy Group

AUGUST 3, 2022

Customers of Aksoy’s fraudulent and counterfeit devices included hospitals, schools, government agencies, and the military.”. Cisco also caught on to the scheme, sending seven cease and desist letters to Aksoy from 2014 – 2020. Is the license valid? But how do they know what they are getting from that site?

Compliance 52

Compliance HIPAA Licensing Governance 52

HIT Consultant

DECEMBER 29, 2022

However, using virtual technology, they connect directly with their personal, licensed speech therapist to work on their concerns in the familiar setting of their home. The federal government is working to improve access. Their speech impairment makes them feel awkward interfacing with others they encounter on such a journey.

COVID-19 94

COVID-19 Hospitals Licensing Doctors 94

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). Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Healthcare Law Blog

MAY 16, 2022

Enrollee Participation in Dual Eligible Special Needs Plan (“D-SNP”) Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. 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

Healthcare Law Blog

JANUARY 10, 2022

Enrollee Participation in Plan Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of certain D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. Key provisions of the Proposed Rule are summarized below. Comments are due by March 7, 2022.

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. Implementing a Constitutional limit, FDA does not regulate a licensed practitioner who makes devices for use in his or her own practice.

FDA 98

FDA Licensing Hospitals Medicaid 98

Hall Render

SEPTEMBER 22, 2023

in repairs Sutter Health faces possible $519M payout in alleged double billing case COLORADO Denver Health sued by sons after father’s jail death How a Kaiser Permanente worker strike could affect Colorado patients Kaiser names regional president Medical Office Building in Littleton Sells for $6.1M

Nursing Homes 40

Nursing Homes COVID-19 Nurses COVID-19 Vaccine 40

Health Populi

JANUARY 5, 2021

When he led Turing Pharmaceuticals in 2015, he acquired a license for the drug Daraprim (an anti-malarial therapy also used for HIV/AIDS), raising the drug price from $13.50 government. (In a pill to $750 a pill. Shkreli was ultimately convicted on securities fraud (not related to the Draprim pricing strategy). In total, U.S.

COVID-19 62

COVID-19 Public Health COVID-19 Vaccine Doctors 62

SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

FDA 52

FDA Compliance COVID-19 Public Health 52

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. 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. at 1291-92.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

MAY 26, 2023

Both talk a fair amount about “commerce” and the respective roles of the states and federal government. You never need an authorization from a licensed professional to buy pork or fireworks. They look a lot like they are analyzing preemption, the DCC, or the plain old CC. See Gross v. Pfizer, Inc. , 2d 654, 659 (D. 3d 470 (4th Cir.

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 2014 WL 12685965, at *6 (S.D.W. 20, 2014), does not even mention the FDA. Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

FEBRUARY 29, 2024

Not all that long after the PREP Act passed, the COVID-19 pandemic started, quickly confirming the importance of freeing government and industry to work together to deploy every type of desperately needed medical resource. The government issued the necessary “public health emergency” declaration in March 2020, and the PREP Act kicked in.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59