Dot Compliance

FEBRUARY 22, 2022

If you’ve developed a new pharmaceutical and want to market it to health care providers or the general public, you must take one first, unskippable step: you need to get it approved by the Food and Drug Administration. FDA regulations govern what you can claim about your product and whether you can even sell it at all.

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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.

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Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. For the reasons discussed below, DTC telehealth platforms should re-visit their compliance plans and be prepared for increased state and federal regulatory scrutiny.

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Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview. I distribute products under an EUA, what do I do now?

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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.

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Hall Render

JANUARY 30, 2025

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.

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Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. As a result, FDA has now established additional requirements for authorization of Respirators made in China.

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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.

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Hall Render

JUNE 21, 2024

Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). In May 2024, the U.S. Below are some highlights from the Final Guidance.

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Healthcare IT Today

AUGUST 28, 2023

Mimi Winsberg, Co-Founder and Chief Medical Officer at Brightside Health We have been in an uncertain time for regulation around telemedicine, and there are a few key trends to watch. As a physician who is invested in complying with current regulations, I welcome clear regulatory guidelines from both the FDA and the DEA on these matters.

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Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Part 820 ), unless they fall under an exemption.

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Healthcare Law Today

JANUARY 11, 2023

Food and Drug Administration (FDA) prior to distribution. As part of a deferred prosecution agreement, which must be approved by the court, Jet Medical admitted that it distributed misbranded devices and agreed to implement enhanced compliance measures. and Martech Medical Products Inc., Pre-submission Meetings.

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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.

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Healthcare IT Today

NOVEMBER 12, 2023

News The 2024 Medicare Physician Fee Schedule continues many telehealth flexibilities first adopted during the public health emergency, such as an expanded scope of originating sites an expanded definition of qualified practitioners. RapidAI received FDA clearance for Rapid SDH , which helps to detect bleeding in the brain.

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HIT Consultant

MAY 9, 2022

The legislation mandated healthcare providers to modernize their internal recordkeeping, allowing for the swifter dissemination of medical information to support public health efforts and better medical care. PDF security features like encryption and redaction can help healthcare organizations achieve greater levels of compliance.

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MedTrainer

OCTOBER 27, 2020

Keys to managing point-of-care testing compliance. In an effort to combat the spread of the virus and to help nursing homes protect the health and safety of their residents, the U.S. Department of Health and Human Services is distributing SARS-CoV-2 antigen diagnostic tests to more than 14,000 facilities. Read the full article.

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MedTrainer

OCTOBER 27, 2020

Keys to managing Point-of-Care Testing Compliance. Keys to managing point-of-care testing complianceIn an effort to combat the spread of the virus and to help nursing homes protect the health and safety of their residents, the U.S. Non-compliance is costly, with penalties in excess of $400 per day, or over $8,000 for each instance.

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HealthIT Answers

DECEMBER 6, 2022

Food and Drug Administration is critical to protecting and promoting public health. The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. By Vid Desai & Craig Taylor - The U.S.

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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. This phaseout is scheduled to occur over four years, starting from the publication date of the Final Rule on May 6, 2024.

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HIPAA Journal

JANUARY 23, 2024

The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. Accurate and dependable diagnostic testing technology is imperative to our public health infrastructure. The company was investigated by the Federal Bureau of Investigation and shut down.

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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. The post Part 2: Who Regulates Healthcare AI?

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HIT Consultant

AUGUST 24, 2022

These include a curated leading genomics database for pathogens to better enable pathogen detection and characterization, a sequencing-based assay to detect SARS-CoV-2 genetic variants, which recently received expanded FDA EUA , and clinical-grade metagenomics assays.

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Healthcare IT Today

NOVEMBER 8, 2023

Many clinical data records can be exchanged between providers and regional public health agencies through health information exchanges. Moving beyond health system-wide or regional interoperability has been a challenge due to several financial and operational hurdles.

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HIT Consultant

APRIL 4, 2023

Regulatory Developments and Adapting Digital Health Startups If circumstances weren’t treacherous enough, digital health startups are bracing for impending regulatory changes. In Q1 2023, an acronym soup of federal agencies (FDA, CMS, DEA, FTC) announced preliminary steps and timelines for refining policies across digital health.

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AIHC

JANUARY 28, 2022

For more information on filing compliance cost reports, attend the Medicare Cost Report Camp in March 2022 presented by KraftCPAs and sponsored by the American Institute of Healthcare Compliance. This is to allow eligible antimicrobial products to begin receiving the new technology add-on payment sooner. billion in FY 2021, or 2.7

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Medisys Compliance

APRIL 20, 2022

As Public Health Emergency (PHE) has extended beyond 16 th April 2022 by 90 days, various waivers are continued, making no change in billing guidelines in pandemic. In fact, concerned authority extended the current COVID-19 pandemic telehealth waivers for five months beyond the end of the public health emergency.

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Healthcare Law Today

NOVEMBER 9, 2022

Prior to the federal COVID-19 Public Health Emergency (PHE), to initiate treatment with buprenorphine at an OTP, a practitioner needed to perform a complete in-person physical evaluation. The covered benefit includes MAT for patients with OUD, a leading treatment modality that combines prescribing FDA-approved medication (e.g.,

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AIHC

FEBRUARY 2, 2022

COVID-19) for discharges occurring on or after April 1, 2020, through the duration of the COVID-19 public health emergency period. • 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

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HIPAA Journal

APRIL 5, 2023

To the HHS’ Office for Civil Rights in response to a patient complaint or compliance audit. To authorized public health authorities to prevent or control disease, injury, or disability. To authorized public health authorities to prevent or control disease, injury, or disability.

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Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications. 1301.28.

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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. Violations of the educational requirements can be subject to fines $1,000 to $3000 per day of violation. [ix] ix] Nevada.

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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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HIT Consultant

NOVEMBER 3, 2024

Justin Sirotin, Founder and CEO of OCTO Amidst the backdrop of the United States being the world’s highest spender on healthcare, a sober reality emerges: despite this immense investment, the nation faces many alarming statistics on the state of public health. is unsustainable.

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SQA

SEPTEMBER 2, 2022

Ma rketing authorization holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’. ISPE Good Practice Guide: Critical Utilities GMP Compliance.

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Health Populi

APRIL 1, 2025

Segment focuses that are informed by individuals’ data along with local contexts and regulatory compliance — Deloitte points to AgeTech and FemTech as examples of specific market penetration opportunities. Virtual assistants embedded with GenAI that will support consumers’ journeys, and, 5. ” and so on.

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SQA

DECEMBER 10, 2021

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. According to ANVISA Public Consultation 1051/2021 , the regulator plans a six-year rollout of UDI requirements in order to boost traceability and monitoring of medical devices and equipment commercialized in Brazil.

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