AIHC

JUNE 6, 2023

Algorithms perform relatively well on knowledge-based tests despite the lack of domain-specific training; ChatGPT achieved ~ 66% and ~ 72% on Basic Life Support and Advanced Cardiovascular Life Support tests, respectively, and performed at or near the passing threshold on the United States Medical Licensing Exam.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Health Care Law Brief

JUNE 2, 2022

For the reasons discussed below, DTC telehealth platforms should re-visit their compliance plans and be prepared for increased state and federal regulatory scrutiny. Provider Licenses. Are all providers licensed or otherwise authorized to render care via telehealth to patients located in a given state?

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Verisys

SEPTEMBER 21, 2023

A big thanks to our compliance team, who monitors state, federal, and international updates. The proposed rules explain that participating physicians and pharmacists must have an active unrestricted license and a Collaborative Agreement. September Regulatory Update – The best resource for monthly updates.

Licensing 52

Licensing Nurses FDA Compliance 52

Innovaare Compliance

OCTOBER 6, 2022

Adult vaccine recommended by ACIP is a covered Part D drug when licensed by the US Food and Drug Administration (FDA) under the Public Health Service Act for use by adult populations and administered in accordance with recommendations of ACIP. or Contact Us. appeared first on Inovaare.

Medicare 52

Medicare Medicare Compliance Public Health 52

Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. License Verification & Monitoring. OIG, SAM DEA, GSA, FDA.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

Healthcare IT Today

JUNE 10, 2023

Factors including FDA approval, a clear value proposition, demonstrated ROI, and an understanding of regulatory processes can all work in a founder’s favor. Hone care vendor Tytocare received FDA approval for a product that analyzes lung sounds captured a handheld device. Navigating Long Buying Cycles in Healthcare Innovation.

FDA 98

FDA Compliance Licensing Hospitals 98

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. Rebates from the selected drugs may change. Additional drugs will be selected for negotiation every year after 2025. [6]

Medicare 52

Medicare Medicare Compliance FDA 52

Healthcare Law Blog

MAY 31, 2022

However, traditional healthcare players, subject to the Health Insurance Portability and Accountability Act (“HIPAA”), may also find themselves innovating in this space (and grappling with how to stand up a HIPAA compliance program in the metaverse). How healthcare providers are licensed in the metaverse is also an open question.

FDA 90

FDA HIPAA Medicare Medicare 90

Verisys

NOVEMBER 14, 2023

Primary source verification must be done to confirm a provider’s education, professional license and certifications, medical training, work history, references, and more. Provider information should be continuously monitored for any changes to exclusion or license status. However, verifying a provider’s credentials is essential.

Licensing 52

Licensing Medicaid Medicaid Governance 52

SQA

MARCH 25, 2021

The approaches are intended to add value, support good business practices, and meet current compliance and regulatory expectations. United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Pharmaceutical Inspection Co-Operation Scheme (PIC/S).

COVID-19 52

COVID-19 FDA Public Health Licensing 52

SQA

JUNE 10, 2021

The CDSCO has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017. FDA plant inspection and pay $50 million in fines and forfeiture. Guidance on the Licensing of Biosimilar Products, 06 May 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. In many states, operating a ketamine clinic does not require a specific regulatory facility license. 8] Often times, the process of obtaining such license requires disclosure of non-physician ownership.

Licensing 40

Licensing Telemedicine COVID-19 FDA 40

HIT Consultant

MAY 9, 2022

With mountains of paperwork generated every year, achieving complete patient privacy and 100 percent compliance can be difficult. PDF security features like encryption and redaction can help healthcare organizations achieve greater levels of compliance. The PDF format also integrates easily into EHR platforms.

FDA 98

FDA COVID-19 Public Health Compliance 98

Verisys

JANUARY 18, 2022

Primary source verification must be done to confirm a provider’s education, professional license and certifications, medical training, work history, references, and more. Provider information should be continuously monitored for any changes to exclusion or license status. Food and Drug Administration (FDA).

Licensing 52

Licensing Medicaid Medicaid Governance 52

Healthcare IT News - Telehealth

AUGUST 19, 2020

AccessHealth’s licensed chemical dependency counselors are integrated within the medical adult clinics. In 2019, AccessHealth was able to reach a compliance rate of 71% by integrating multidisciplinary departments with medical concerns, such as mental health, nutrition, care coordination and social determinants of health.

COVID-19 174

COVID-19 Telemedicine Compliance HIPAA 174

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

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

Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

Health Law Advisor

MARCH 1, 2023

On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). 2] Statements of Charges may be found on the Washington State Department of Health website, filed under the individual provider’s name and/or license number.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

SQA

MAY 17, 2022

China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022. The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements. United States Food and Drug Administration (FDA) – Regulations and Guidances.

FDA 75

FDA Compliance Informed Consent Hospitals 75

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 IT Today

JANUARY 19, 2024

With the majority of AI tools lacking the necessary FDA clearance for use in healthcare settings, health systems will need to properly evaluate their AI investments to prioritize legitimized solutions that will ensure patient safety and legal compliance.”

Hospitals 102

Hospitals Governance FDA Licensing 102

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

Natalia Mazina

FEBRUARY 6, 2024

The only exception would be distributing FDA approved CBD products (such as Epidiolex). It is facing a dilemma: the need to provide access to medical marijuana and avoid non-compliance for its pharmacies. It is facing a dilemma: the need to provide access to medical marijuana and avoid non-compliance for its pharmacies.

FDA 52

FDA Compliance Licensing 52

Hall Render

SEPTEMBER 1, 2023

operating margin, $1B net gain halfway through its first year Illinois public health officials warn of “rising COVID-19 activity” St. Warner, Kaine announce nearly $1.4M operating margin, $1B net gain halfway through its first year Aspirus Health seeking merger partners beyond St.

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

SQA

SEPTEMBER 2, 2022

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. ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems .

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. An applicant will also need to satisfy certain prelicensure requirements and complete continuing education to maintain their license.

Licensing 52

Licensing Compliance FDA Public Health 52

Healthcare Law Today

DECEMBER 19, 2022

FDA Regulatory Considerations for the U.S. Market : Digital Health and Clinical Trials – (a) Determining whether product is regulated as a device; (b) FDA pathways; (c) Clinical trial issues; (d) Compliance issues when contracting with health care providers. To register for the program, please click here.

Telemedicine 64

Telemedicine FDA Licensing Governance 64

Healthcare IT News - Telehealth

MAY 6, 2020

The company’s Carnation Ambulatory Monitor (CAM) Patch is a P-wave centric ambulatory cardiac monitor and arrhythmia detection device that also is designed to improve patient compliance for both adults and children through its lifestyle-enabling form factor.

COVID-19 183

COVID-19 FDA Hospitals Elder Care 183

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

Healthcare IT Today

APRIL 18, 2023

XRHealth integrates immersive virtual reality and augmented reality (AR) technology, licensed clinicians, and advanced data analytics on one platform, providing a comprehensive therapeutic care solution that enables patients to receive treatment from the comfort of their homes. Sanfeliu, Managing Partner at Asabys.

Licensing 59

Licensing FDA Hospitals Compliance 59

Hall Render

MARCH 31, 2023

in 2022, survey finds Senate votes to end COVID-19 national emergency Why are 600+ rural hospitals at risk of closing? What happens if it disappears? Cooper signs bipartisan Medicaid expansion into law Greensboro medical office building sold for $1.65

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses COVID-19 40

AIHC

FEBRUARY 2, 2022

The post Coding COVID for Uninsured Patients appeared first on American Institute of Healthcare Compliance. Encounter for screening for other viral diseases (asymptomatic) Z11.52 Encounter for screening for COVID-19, asymptomatic Z20.822 Contact with and (suspected) exposure to COVID-19 Z86.16

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Medicare Medicare 52

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in color and typeface and uses the BTNX Inc. device identifier “COV-19C25.”

US Department of Health and Human Services 40

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

Hall Render

FEBRUARY 18, 2022

License wait times reach crisis levels for healthcare workers. Meet new FDA chief Dr. Robert Califf: 5 things to know. Only 14% of Hospitals Met Price Transparency Rule Compliance. Montana health facilities report vaccine compliance, with some leaving jobs. Hospitals urge HHS to fix, not end, direct contracting model.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

Hall Render

MARCH 3, 2023

million for youth mental health care KENTUCKY Pike County nursing home officials release statement following loss of Medicare agreement Three Humana executives drop $11.2M

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40