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.

Telemedicine 59

Telemedicine COVID-19 Compliance Informed Consent 59

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.

HIPAA 78

HIPAA Informed Consent Nurses Compliance 78

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.

Medical Billing Outsourcing 59

Medical Billing Outsourcing Informed Consent Medical Billing Medicare 59

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.

COVID-19 52

COVID-19 Nursing Homes 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.

FDA 40

FDA Informed Consent COVID-19 Fraud 40

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.

Medical Billing Outsourcing 52

Medical Billing Outsourcing Medical Billing Informed Consent Nurses 52

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.

Due Diligence 40

Due Diligence Licensing Informed Consent HIPAA 40

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.

Medical Billing 52

Medical Billing Health Insurance Hospitals Medicare 52

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.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

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.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

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).

FDA 75

FDA Compliance Informed Consent Hospitals 75

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.

Governance 65

Governance HIPAA World Health Informed Consent 65

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.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

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.

Doctors 52

Doctors Fraud Licensing Compliance 52

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?

Informed Consent 59

Informed Consent Malpractice Compliance 59

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.

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59