MedTrainer

JUNE 4, 2024

Maintaining compliance in hospitals, health centers, and other clinically based pharmacies goes beyond the handling, dispensing, and prescribing of drugs. Pharmacy compliance rules require staff to properly manage electronic prescriptions, maintain mandatory licenses, and complete continuing education (CE) courses.

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Compliance Licensing Governance FDA 52

MedTrainer

APRIL 22, 2024

Creating and using a supplier compliance checklist ensures vendors meet regulatory requirements and are trusted partners in managing sensitive information. In this article, I’ll discuss why supplier compliance is as critical as legal and regulatory adherence for healthcare organization employees.

Compliance 52

Compliance HIPAA Licensing Fraud 52

Healthcare IT News - Telehealth

AUGUST 6, 2024

UpScriptHealth also works with other medical device companies to increase access – for example, it powers telehealth consultations for Spark Biomedical's Sparrow Ascent, the only FDA-cleared, drug-free, non-addictive, non-invasive, wearable treatment technology for the relief of opioid withdrawal symptoms.

Telemedicine 148

Telemedicine FDA HIPAA Licensing 148

Verisys

DECEMBER 12, 2023

– The best resource for monthly healthcare regulatory compliance updates. Rule 402(2) states that when a multistate licensee changes primary states of residence to another NLC party states, they shall apply for a multistate license in the new residence state within 60 days. 01ER ): Effective as a permanent rule on 11/13/2023.

Regulatory Compliance 52

Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

MedTrainer

JANUARY 12, 2024

Healthcare compliance is serious business for regulators. In this blog post, we’ll outline who regulates healthcare compliance, how rules are enforced, and why organizations need a robust compliance platform to stay in the good graces of regulators. What is Healthcare Compliance? Who Regulates Healthcare Compliance?

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Healthcare IT Today

OCTOBER 7, 2024

This allows organizations to identify compliance issues as early as possible as well as perform impact analysis as newly discovered security vulnerabilities are reported outside the organization. Security Documentation is Essential As a general rule, manufacturers are responsible for the security of the software in their products.

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FDA Compliance Licensing HIPAA 116

Hall Render

OCTOBER 18, 2024

Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023.

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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-19 216

COVID-19 FDA Hospitals Elder Care 216

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 59

Compliance Medical Billing HIPAA Due Diligence 59

Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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FDA Licensing Compliance 40

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

Hall Render

SEPTEMBER 15, 2023

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to be 5-HT2 agonists (e.g.,

FDA 40

FDA Licensing Compliance 40

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.

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FDA HIPAA Medicare Medicare 90

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

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

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.

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FDA Compliance Licensing Hospitals 85

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

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.

Medicare 52

Medicare Medicare Regulatory Compliance Medicaid 52

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

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FDA Compliance Regulatory Compliance Licensing 40

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.

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Licensing FDA Hospitals Compliance 64

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.

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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

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

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

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

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

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 94

Hospitals Governance FDA Licensing 94

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.

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FDA Licensing Hospitals Medicaid 98

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 .

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FDA COVID-19 Nursing Homes Public Health 91

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. Schedule 3 drugs must be approved by the Food and Drug Administration (FDA,) prescribed by a doctor, and distributed by a pharmacy.

FDA 214

FDA Bioethics Compliance Telemedicine 214

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.

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FDA Compliance Informed Consent Hospitals 75

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-19 211

COVID-19 Telemedicine Compliance HIPAA 211

Healthcare IT Today

DECEMBER 27, 2024

Vijay Mohan, VP, Industry Solutions and Global Life Sciences Leader at o9 Solutions Healthcare supply chains are extremely complex, with global networks requiring precise coordination, specialized shipping, regional regulatory compliance, and constant readiness to deliver critical supplies.

US Department of Health and Human Services 58

US Department of Health and Human Services Hospitals Nurses Compliance 58

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

SQA

AUGUST 1, 2024

Companies participating in the program will receive annual audits to monitor the risk and verify the maintenance of compliance with GMP, contributing to the control of the health risk of the products. Non-Compliance Rating for Upmaid Technologies Inc., This indicated a lack of proper implementation of the necessary CAPAs.

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FDA Licensing Compliance World Health 40

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

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.

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