MedTrainer

JULY 13, 2023

As the VP of Compliance at MedTrainer, I’m not only intrigued by the potential of this technology, but also by the new questions and concerns related to AI and healthcare compliance. These are some of the most common concerns around AI and healthcare compliance.

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MedTrainer

JUNE 29, 2023

Compliance isn’t a concept with a lot of grey area — you’re either compliant with regulations or you’re not! Unfortunately, this yes or no perspective often leads to the misconception that compliance tracking is easy. And, in fact, there are times when tracking compliance can be as difficult as meeting the compliance standard itself!

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. – Aftercare service : Whether to offer virtual support and/or an optional care package purchased by members at a clinic? 4 And compliance decrease over time. . – What new opportunities will arise? Introducing OTC hearing aids. – Fraud.

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Compliancy Group

MAY 24, 2024

Compliance with the Office of Inspector General’s (OIG) guidelines is more than a legal necessity in the pharmaceutical manufacturing industry. The OIG compliance program guidance for pharmaceutical manufacturers provides a roadmap for navigating complex regulatory landscapes and avoiding costly violations.

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AIHC

JUNE 6, 2023

AI Use in Healthcare Research & Quality As posted in the American Institute of Healthcare Compliance (AIHC) June monthly newsletter, the Agency for Healthcare Research & Quality (AHRQ) grantee is testing AI for use to improve breast cancer screening accuracy and efficiency. Beware of new companies offering such services.

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Compliance Now

MARCH 8, 2022

By: Megan Diehl, Manager, Compliance Consulting, MZQ Consulting. The HRSA, which maintains responsibility for the comprehensive guidelines for women, recently issued new guidance that updates and expands the list of women’s preventive services. An update to the list of women’s contraceptives found in the FDA Birth Control Guide.

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ACA FDA Compliance 188

HIT Consultant

MAY 2, 2024

– The Centers for Medicare and Medicaid Services (CMS) created two new coverage codes specifically for POGO Automatic, recognizing this new and significantly different technology compared to traditional blood glucose meters (BGMs). What You Should Know: – Intuity Medical, Inc., million seniors age 65 and up living with diabetes.

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Medicare Medicare FDA Medicaid 96

AIHC

JUNE 6, 2023

AI Use in Healthcare Research & Quality As posted in the American Institute of Healthcare Compliance (AIHC) June monthly newsletter, the Agency for Healthcare Research & Quality (AHRQ) grantee is testing AI for use to improve breast cancer screening accuracy and efficiency. Beware of new companies offering such services.

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Compliance Medical Billing HIPAA Due Diligence 52

HIT Consultant

APRIL 12, 2024

What You Should Know: – Philips Respironics , a subsidiary of Royal Philips, has finalized a consent decree with the US Department of Justice (DOJ) and Food and Drug Administration (FDA) to address issues raised during a 2021 inspection of a Philips facility in Pennsylvania.

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Healthcare IT Today

FEBRUARY 12, 2024

As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access to quality vision care nationwide. Visibly , a leading healthcare technology company, is thrilled to announce the merger of Visibly and EyecareLive.

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Hall Render

JANUARY 11, 2023

Department of Health & Human Services (“HHS”) updated the Mobile Health App Interactive Tool (the “Tool”) to include new questions and new use cases. Just a few months ago, the FDA released final guidance that clarifies the factors the agency uses to determine whether a software function is subject to its regulatory oversight.

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Compliance HIPAA FDA Due Diligence 40

Innovaare Compliance

OCTOBER 6, 2022

According to the Centers for Medicare & Medicaid Services (CMS), enrollment in MAPD keeps rising. If you have any questions, or you’d like to discuss these changes with one of our compliance experts, please call us at 1.408.850.2235. In 2022, 48% of all eligible Medicare beneficiaries are enrolled in MAPD. or Contact Us.

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Medicare Medicare Compliance Public Health 52

HIT Consultant

OCTOBER 17, 2023

What You Should Know: – Densitas ® , a provider of artificial intelligence solutions for breast cancer screening, announced a strategic partnership with Intelerad Medical Systems ® , a provider of medical imaging software and services to advance AI-driven breast cancer screening.

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Dot Compliance

JUNE 16, 2022

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance.

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Compliance Now

JANUARY 20, 2022

The ACA requires non-grandfathered health plans to pay for “preventive care” on a first-dollar basis, meaning that no copays, coinsurance, or deductibles can be charged for certain services defined as “preventive” under these rules. Thus, these colonoscopies and the associated services must also be provided at no cost to the participant.

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Healthcare Law Today

NOVEMBER 9, 2022

Starting January 1, 2023, Medicare will cover telehealth-based treatment services delivered by federally-accredited opioid treatment programs (OTPs), commonly referred to as “methadone clinics.” CMS also extended coverage for SUD treatment services provided via telehealth.

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Healthcare IT Today

AUGUST 28, 2023

Stephen Sofoul, SVP, Data & Decision Science Services at MultiPlan A critical challenge lies in the shortage of experienced financial analysts or data analysts capable of effectively analyzing the wealth of information that the healthcare industry holds. The following is what they had to say.

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US Department of Health and Human Services Telemedicine Hospitals Compliance 117

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. The severity and type of risk present in a telehealth business will vary—by jurisdiction, by provider type, by service offering, and by payor mix.

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Healthcare IT Today

MAY 19, 2024

Care navigation company Quantum Health expanded its specialty pharmacy services. CLEW Medical received 510(k) clearance from the FDA for its machine learning models that predict patient deterioration. Certifications ClearDATA achieved AWS Level 1 MSSP Competency status for its healthcare cloud, compliance, and security services.

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HIT Consultant

OCTOBER 21, 2022

US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. Every six months, CMS puts out a compliance score for each hospital. Rolland Carlson, CEO of Immunexpress. An external motivator is reinforcing the trend.

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Hospitals FDA Compliance COVID-19 98

HIT Consultant

SEPTEMBER 26, 2023

launch of its next-generation Zio® monitor and enhanced Zio® long-term continuous monitoring (LTCM) service. Zio monitor is iRhythm’s smallest, lightest and thinnest cardiac monitor, enhancing the cardiac monitoring experience for patients and healthcare providers together with new service enhancements. today announced the U.S.

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MedTrainer

OCTOBER 27, 2020

Keys to managing point-of-care testing compliance. Department of Health and Human Services is distributing SARS-CoV-2 antigen diagnostic tests to more than 14,000 facilities. While this cleared the way to proceed with antigen testing, it did not clarify outstanding differences in guidance previously issued by the FDA, CDC and CMS.

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MedTrainer

OCTOBER 27, 2020

Keys to managing Point-of-Care Testing Compliance. Department of Health and Human Services is distributing SARS-CoV-2 antigen diagnostic tests to more than 14,000 facilities. While this cleared the way to proceed with antigen testing, it did not clarify outstanding differences in guidance previously issued by the FDA, CDC and CMS.

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Compliance Nursing Homes COVID-19 Nurses 40

Healthcare IT Today

JUNE 7, 2023

Many of our concerns center on the proposed implementation timeframes associated with various concepts included in HTI-1, as well as ONC’s failure to sufficiently consider the burden compliance will place on provider organizations and health IT developers. 31, 2024, compliance timeline is unrealistic.

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Healthcare Law Blog

MAY 31, 2022

Developers and other players in the metaverse offering health-related products and services will face an ever-growing patchwork of state and federal privacy and data security laws. In response to the growth of the metaverse and digital health generally, the FDA has been working to expand its guidance in the area.

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AIHC

JUNE 14, 2023

Artificial Intelligence & Regulatory Compliance Written by Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023.

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FDA HIPAA Compliance Regulatory Compliance 45

American Medical Compliance

MAY 16, 2024

Languages: American English Key features: Audio narration, learning activity, and post-assessment Get Certified American Medical Compliance (AMC) is a leader in the industry for compliance, Billing and HR solutions. To become certified, please visit us at American Medical Compliance (AMC).

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Public Health Compliance FDA Hospitals 52

American Medical Compliance

MAY 13, 2024

Languages: American English Key features: Audio narration, learning activity, and post-assessment Get Certified American Medical Compliance (AMC) is a leader in the industry for compliance, Billing and HR solutions. To become certified, please visit us at American Medical Compliance (AMC).

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Compliance Public Health Governance FDA 52

HIT Consultant

JULY 25, 2022

Consumers continue to cut ties with traditional TV and cable services, prompting industries like the prescription pharmaceutical industry to evolve their marketing mix to accommodate emerging media. . She has held leadership roles in account service at VDX.tv Digital video formats can also support both short and long-form videos.

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HIT Consultant

APRIL 10, 2024

Take Pear Therapeutics , for example, which recently went bankrupt, although its reset substance use disorder program was the first ever digital therapeutic tool to receive FDA clearance. All compliance and security information must therefore be made accessible to them. What are the hurdles for patients?

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Doctors Compliance Framework Compliance FDA 119

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. Jesse Burke, Director of IT at HealthWorks for Northern Virginia, had to manage multiple third-party service providers to maintain on-premises IT infrastructure.

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Compliancy Group

NOVEMBER 2, 2022

The Food and Drug Administration (FDA) recognized this when they released guidance for medical device manufacturers to increase cybersecurity. Medical device manufacturers must submit a ‘Cybersecurity Bill of Materials’ during premarket reviews to the FDA for review. HIPAA compliance can help you address your security needs.

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Healthcare IT Today

SEPTEMBER 3, 2023

In a report , the Digital Medicine Society identified three priorities for successful digital health product innovation: Alignment between the FDA and payer decision-makers, alternate pathways to market for novel products, and better coordination among FDA business units. Sales Banner Health chose nference for biomedical data analysis.

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Healthcare IT Today

FEBRUARY 25, 2024

Clearwater is partnering with 25m Health to develop a cybersecurity and compliance program for health tech startups. Edifecs said it will now enable compliance with CMS Interoperability and Prior Authorization Final Rule. Family caregiver education platform Trualta is now available through PointClickCare’s Marketplace.

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Telemedicine Compliance FDA Hospitals 113

Dot Compliance

NOVEMBER 21, 2022

In essence, it offers the framework for multiple organizational functions to collaborate and produce the highest-quality goods and services to the client. The purpose of medical device quality management systems (QMS) is to make it easier to adhere to FDA requirements and standards like ISO 13485. Quality Management in Medical Device.

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HIT Consultant

MARCH 7, 2022

Earlier last year, the FDA issued an emergency use authorization (EUA) for monoclonal antibody treatments bringing additional needs for infusion treatments in many alternate care settings. Similar to 2020, there were increases in demand in 2021 for infusion pumps to treat COVID-19 patients.

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Dot Compliance

SEPTEMBER 11, 2022

The United States Food and Drug Administration (FDA) has the authority to enforce compliance with the Code of Federal Regulations , which has significant consequences if disregarded. Considering ISO 9001:2015 certifications makes sense for pharmaceutical managers given the requirement for compliance, quality, and safety.

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