Healthcare IT Today

MARCH 26, 2025

Federal and state agencies, including the Drug Enforcement Administration ( DEA ) and the Food and Drug Administration (FDA), are shaping the future of telehealth through evolving policies. The FDA also plays a key role in overseeing online pharmacies to ensure they comply with federal drug distribution laws.

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American Medical Compliance

MARCH 19, 2025

American Medical Compliance is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education to physicians. American Medical Compliance designates this activity for a maximum of 0.75 To become certified, please visit us at: American Medical Compliance (AMC).

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Healthcare IT Today

MARCH 24, 2025

As a pioneer in the field of lymphedema detection and monitoring, ImpediMed offers the only FDA-cleared bioimpedance spectroscopy (BIS) technology for the clinical assessment of breast cancer-related lymphedema (BCRL) the SOZO Digital Health Platform. health payors now providing coverage for over 258 million covered lives.

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HIPAA Journal

DECEMBER 8, 2022

The tool will point developers to resources where they can find out more information about their compliance obligations, along with best practices to help them deliver a safe and accurate service while ensuring the privacy and security of the health information of app users. The updated version can be found here.

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The Digital Health Corner

AUGUST 7, 2017

The FDA recently announced its Digital Health Innovation Action Plan. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. The FDA will have new digital health experts. This plan was both important and necessary.

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HIT Consultant

APRIL 5, 2023

What You Should Know: Dot Compliance , a leading provider of eQMS compliance solutions for the life sciences sector, has introduced an industry-first, ready-to-use AI-Based electronic Quality Management System for life sciences, powered by an embedded generative and predictive artificial intelligence.

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Dot Compliance

JANUARY 14, 2025

Ensuring quality and compliance across an organization continues to be the foundation for effective devices and drug products across the life sciences industry. With an automated solution that eliminates the manual work while ensuring quality and compliance across your business. Whats the best way to do this?

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Verisys

APRIL 8, 2025

Youll learn how each level works, what databases they include, and how to choose the right option for your organizations compliance and patientsafety goals. FACIS Level 1M meets and exceeds the minimum standards set forth by the Office of Inspector General (OIG) Compliance Program Guidance. Treasury Dept U.S.

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Compliance Now

MARCH 8, 2022

By: Megan Diehl, Manager, Compliance Consulting, MZQ Consulting. An update to the list of women’s contraceptives found in the FDA Birth Control Guide. Under the ACA, non-grandfathered group health plans must provide benefits for “preventive care” on a first-dollar basis. no co-payments, co-insurance, or deductibles may be applied).

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Healthcare IT Today

JANUARY 3, 2025

AI will become fundamental to drug development processes post-discovery outside of clinical trials, like quality and regulatory compliance, because of the immediate ROI and complexity reduction it can provide. There will be no in-between. That would send shockwaves through the whole pharma industry.

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Dot Compliance

FEBRUARY 5, 2025

These records are essential for ensuring consistency, safety, and compliance in the pharmaceutical industry. Each step in the process plays a role in maintaining compliance and preventing product recalls, making BMR review a vital part of quality assurance. Equipment Calibration: Documentation of equipment calibration and maintenance.

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Compliancy Group

NOVEMBER 4, 2024

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

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Dot Compliance

NOVEMBER 20, 2023

Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards. For companies in the manufacturing, processing, packing, or holding of drugs, compliance with 21 CFR Part 210 and 21 CFR Part 211 is not just a regulatory requirement; it’s the key to producing safe and effective pharmaceutical products.

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. 4 And compliance decrease over time. . By allowing retail sales of affordable hearing aids, the FDA regulations go a long way in helping consumers address this challenge yet could result in risk to health plans. – What new opportunities will arise?

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Bill of Health

MARCH 13, 2025

FDA and Food Marketing Institute v. That would help preserve the integrity of the absolute novelty rule while protecting compliance. By contrast, the U.S. Recent court decisions, including Seife v. Argus Leader , have further strengthened broad confidentiality protections.

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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.

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Dot Compliance

FEBRUARY 25, 2025

Every brochure, website, social media post, and sales presentation must adhere to strict guidelines FDA regulations, global standards, and constantly evolving requirements. Automated Workflows: Streamlined review and approval processes that ensure compliance with internal policies and external regulations.

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Compliancy Group

DECEMBER 4, 2024

Food and Drug Administration (FDA). The FDA debarment list for medical devices flags third parties guilty of non-compliance with FDA regulations. Screening potential and current vendors against the FDA debarment list should be part of your routine background checks.

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Verisys

JULY 8, 2024

Stabilization Period: The FDA has established a one-year stabilization period from November 2023 to November 2024 to allow trading partners to fully implement and troubleshoot their electronic systems without disrupting the supply chain. Without the proper compliance processes, risk for the patient and organization is added to the ecosystem.

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Dot Compliance

JANUARY 29, 2025

Improved Compliance and Risk Management Regulatory compliance: eQMS solutions help organizations meet industry-specific regulations, such as FDA, ISO 9001 , and GMP, by providing built-in compliance features. Compliance: Verify that the eQMS complies with relevant data privacy regulations, such as GDPR or HIPAA.

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Verisys

JULY 8, 2024

Stabilization Period: The FDA has established a one-year stabilization period from November 2023 to November 2024 to allow trading partners to fully implement and troubleshoot their electronic systems without disrupting the supply chain. Without the proper compliance processes, risk for the patient and organization is added to the ecosystem.

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Dot Compliance

FEBRUARY 22, 2022

FDA regulations govern what you can claim about your product and whether you can even sell it at all. For companies that manufacture drugs, biotechnology, and related products, demonstrating the safety and effectiveness of your goods to the FDA’s satisfaction has to be a top priority. What is the process for FDA drug approval?

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Dot Compliance

JANUARY 22, 2025

Audit Management Audit Scheduling: Plan and schedule internal and external audits to assess compliance with quality standards and regulations. Compliance Tracking: Ensure that employees receive the necessary training to meet regulatory requirements and job responsibilities. ISO 9001, FDA 21 CFR Part 11, ISO 13485 ). GDPR, CCPA).

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Dot Compliance

NOVEMBER 2, 2022

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. Compliance Dashboard, Inspections, FDA, accessed October 3, 2022, [link] cd/inspections.htm ).

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Dot Compliance

APRIL 11, 2025

The life sciences industry is highly regulated and patient-centric, making compliance a critical component for all companies involved in the manufacture or distribution of these products. Conduct audits to verify compliance with regulations, standards, and internal procedures.

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Bill of Health

JANUARY 19, 2022

Factors Associated with Compliance to the Hospital Price Transparency Final Rule: a National Landscape Study. A full posting of abstracts/summaries of these articles may be found on our? Barber M, Sarpatwari A, Cepuch C. COVID-19 antivirals must not affect HIV drug supply. JAMA Intern Med. 2021 Dec 13. Epub ahead of print. J Gen Intern Med.

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Bill of Health

DECEMBER 6, 2024

These technologies can act as privacy enhancing techniques (PET) to ensure privacy and compliance with regulations like HIPAA and GDPR. US Legal Requirements for Quantum-Powered Medical Devices In the United States, some quantum-powered medical devices may be governed under the existing FDA regulatory framework.

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Dot Compliance

NOVEMBER 2, 2022

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. Without FDA notification, companies may get this paper in the mail.

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Dot Compliance

FEBRUARY 15, 2024

On January 31st, 2024, almost a year after the Food and Drug Administration (FDA) published its proposed rule for the harmonization of quality system regulation (QSR) and ISO 13485, it has issued its final rule. director of the FDA’s Center for Devices and Radiological Health. What Is QMSR?

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Dot Compliance

MAY 3, 2024

In the pharmaceutical industry, the importance of regulatory compliance extends beyond fulfilling legal obligations. Compliance can be streamlined with the help of an electronic quality management system (eQMS) that incorporates regulatory standards into every operational aspect of a pharmaceutical organization.

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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.

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Health Law Advisor

JANUARY 4, 2022

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly released dashboard for FDA inspections. Some years FDA may conduct many inspections; other years not so many.

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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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