Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Informed consent includes the following basic elements: Description of clinical investigation.

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Healthcare IT Today

OCTOBER 20, 2023

The following is a guest article by Nate MacLeitch , Founder and CEO at QuickBlox The demand for AI-powered Communications Platform as a Service (CPaaS) in healthcare is evident: 75% of executives believe that generative AI has reached a stage where it is poised to reshape the healthcare industry.

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MedTrainer

NOVEMBER 5, 2023

Colorado, like other states in the United States, has its own set of regulations and requirements that make managing healthcare compliance in Colorado tricky. To effectively manage compliance, healthcare organizations must establish a robust system for monitoring and interpreting these changes and swiftly implement necessary adjustments.

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Healthcare IT Today

MARCH 14, 2025

This includes requiring vendors to sign Business Associate Agreements (BAAs) that clearly define their compliance responsibilities, verifying that the vendors AI models are trained on secure, compliant datasets, and ensuring all data handling aligns with HIPAAs technical and administrative safeguards.

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MedTrainer

OCTOBER 4, 2023

Corporate compliance training helps healthcare organizations balance the need to provide top-notch care with adhering to a plethora of regulations. What Is Corporate Compliance Training? What Is the Difference Between Corporate Compliance Training and Regulatory Compliance Training?

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Compliancy Group

OCTOBER 21, 2024

The Health Insurance Portability and Accountability Act (HIPAA) compliance patient consent form is essential for properly using and disclosing protected health information (PHI). Failure to get informed consent can have dire consequences for your organization.

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Compliancy Group

MARCH 25, 2024

In today’s complex healthcare landscape, compliance is crucial. A healthcare compliance due diligence checklist is one essential tool that can help organizations in their quest for compliance. What is a Healthcare Compliance Due Diligence Checklist? What is a Healthcare Compliance Due Diligence Checklist?

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MedTrainer

JANUARY 15, 2025

Most compliance systems fail over time because they are based on the skills of an individual or they have stretched the limits of a program that the organization has outgrown. What Is a Plan of Correction in Healthcare Compliance? How many programs / systems does my compliance program utilize?

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Medisys Compliance

JULY 23, 2024

Introduction Radiation oncology billing is a complex and evolving field that requires specialized knowledge to ensure accurate reimbursement and compliance with regulatory standards. This article will explore the latest developments, new billing codes, compliance tips, and strategies to optimize reimbursement.

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Medical Billing Outsourcing Compliance Informed Consent Medical Billing 59

AIHC

SEPTEMBER 5, 2023

Compliance Considerations for Best Outcomes Written in collaboration with the AIHC Volunteer Education Committee Delivering mental health services via telehealth has increased since the COVID-19 pandemic. This article is not intended as legal or consulting advice. Telehealth rules and regulations vary greatly by state.

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Medisys Compliance

FEBRUARY 13, 2024

Ensure informed consent is obtained for treatment and billing practices. Staying informed about billing updates and specific payer requirements is crucial for continued compliance and efficiency. Remember, billing for less than 53 minutes under this code or submitting vague documentation can lead to claim denials.

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AIHC

OCTOBER 11, 2021

Written By: Compliance Blogger This article addresses COVID testing and consent considerations for: healthcare organizations, nursing homes and business associates or non-healthcare workplaces. This article is not intended as legal or consulting advice. Encourage and answer questions during the consent process.

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Medisys Compliance

FEBRUARY 29, 2024

This article explores into the key considerations for optimizing billing for virtual care in primary care, ensuring you receive proper reimbursement for your services. Capture Patient Consent: Document the patient’s informed consent for receiving care via telehealth services.

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Medical Billing Outsourcing Informed Consent Medical Billing Medicare 59

Medisys Compliance

APRIL 30, 2024

This article provides a comprehensive guide for anesthesiologists and providers on telehealth anesthesia billing, covering key aspects of telehealth billing. Patient Consent: Obtain informed consent from patients before conducting a telehealth consultation.

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Medical Billing Outsourcing Medicare Medicare Informed Consent 59

Medisys Compliance

APRIL 11, 2022

In this article, we shared list of required documents for ambulatory surgery centers who are beneficiaries of Medicare. Informed consent. Documentation of compliance with discharge criteria Condition of the patient on discharge. Documentation of vital signs, assessments, and other findings. Nurses’ notes.

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Medical Billing Outsourcing Medical Billing Informed Consent Nurses 52

Hall Render

SEPTEMBER 14, 2023

For health care institutions conducting DCTs, considerations include compliance with fraud and abuse and beneficiary inducement requirements. Hall Render blog posts and articles are intended for informational purposes only.

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SQA

MAY 17, 2022

China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022. For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s).

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HIPAA Journal

JANUARY 16, 2023

This article aims to answer the questions what AI in healthcare is, what are – or what will be – the benefits of AI in healthcare, and how can concerns about the ethics of AI in healthcare be overcome. These concerns are not unique to the United States nor to the healthcare industry.

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Governance HIPAA World Health Informed Consent 64

SQA

APRIL 30, 2021

EC Issues Notice on the Handling of Duplicate Marketing Authorization Applications (MAAs) of Pharmaceutical Products under Article 82(1) of Regulation (EC) No. The European Commission (EC) has issued a notice on the handling of duplicate MAAs of pharmaceutical products under Article 82(1) of Regulation (EC) No.

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COVID-19 Vaccine COVID-19 Compliance Governance 52

AIHC

JANUARY 5, 2022

This article is a follow up to the August 17, 2021, Sending “Surprise” Medical Bills to Patients? The nonparticipating provider or facility provides the beneficiary, enrollee or participant with a written notice and obtains consent that includes certain content and within a specific timeframe and format outlined in regulation and guidance.

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C&M Health Law

JUNE 15, 2021

This article was originally published in Corporate Compliance Insights. Suppose that a biopharmaceutical enterprise submits regulatory approval for a new product, only to realize that the data collected from outsourced clinical trials is based on insufficiently informed consent.

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SQA

FEBRUARY 15, 2023

The application/notification must be submitted via the EUDAMED database (Article 69 IVDR). It includes aspects such as home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs, and electronic informed consent.

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Healthcare IT Today

JUNE 13, 2024

Ownership and protection of data are paramount, with compliance issues such as HIPAA regulations adding complexity. Questions surrounding the sharing of proprietary information and the risk of algorithmic compromise or manipulation heighten ethical concerns. This creates the opportunity for bias related to location.

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AIHC

AUGUST 13, 2024

The American Institute of Healthcare Compliance (AIHC) Volunteer Education Committee has written this article in response to several requests for more information on the Final Rule, which aims to ensure that all people have non-discriminatory access to healthcare. The effective date was July 5, 2024.

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Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Plaintiffs’ own litigation strategy thus opened the door to compliance evidence.

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Drug & Device Law

APRIL 21, 2023

Heck, Bexis and our colleague Matthew Jacobson even wrote a law review article on the topic a few years back. That would be especially true in states where regulatory compliance is a defense or partial defense. So maybe the manufacturer’s duty to warn and the physician’s duty to obtain informed consent merge.

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Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. has no power to enforce compliance”), aff’d , 405 F.

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Drug & Device Law

JANUARY 28, 2022

For instance, Plaintiffs relied on a medical journal article that compared the product at issue with the defendant’s own TVT product. She sued the gynecologist, not the surgeon who implanted the mesh, for failing to obtain informed consent for the implant. at *13-*14. That’s right. Can she do that?

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