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. It is just too important to forego.

Due Diligence 40

Due Diligence Licensing Informed Consent HIPAA 40

Bill of Health

SEPTEMBER 2, 2022

This article addresses key harms and biases associated with the SDOH technology movement, and provides suggestions to address these issues going forward. Informed Consent and Refusal. Ultimately, SDOH implementers, evaluators, and stakeholders should: Establish mechanisms for informed consent and refusal.

Informed Consent 246

Informed Consent Medicaid Medicaid Public Health 246

Bill of Health

OCTOBER 13, 2023

There is no specific regulation governing such research in the U.S.; it’s just that the federal government won’t fund the research. This article is lightly edited and reprinted, with permission, from the American Council on Science and Health. The original article can be found here. To date, most, if not all, U.S.

Bioethics 298

Bioethics Informed Consent Governance Licensing 298

Healthcare IT Today

DECEMBER 22, 2023

The following is a guest article by Amy Hester, PhD, RN, BC, FAAN, Chairwoman and CEO at HD Nursing The growing use of artificial intelligence (AI) across a number of industries, particularly in healthcare, has shown both great promise as well as cause for alarm.

US Department of Health and Human Services 98

US Department of Health and Human Services Nurses Informed Consent Doctors 98

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. The inspection resulted in a non-compliant rating.

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

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. Ethics of AI in Healthcare . These concerns are not unique to the United States nor to the healthcare industry.

Governance 65

Governance HIPAA World Health Informed Consent 65

Bill of Health

AUGUST 29, 2022

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials. In this post, I argue that young people should have the opportunity to consent to vaccines. Victoria Kalumbi received her JD from Harvard Law School in 2022.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Bill of Health

SEPTEMBER 21, 2022

Professionals within a professional relationship are subject to a variety of legal constraints, such as informed consent requirements or professional malpractice liability if things go wrong. What happens if he continues to give bad health advice in what is then a government role? Dr. Mehmet Oz (@DrOz) April 3, 2020.

Malpractice 363

Malpractice Licensing Informed Consent Doctors 363

Kaiser Health News

NOVEMBER 27, 2023

“We’re not going to be like California and have massive numbers of people on government programs without work requirements,” DeSantis said at a presidential primary debate in Southern California earlier this year. California bans short-term health plans.

COVID-19 Vaccine 107

COVID-19 Vaccine COVID-19 Medicaid Medicaid 107

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. In 2023, these include United States ex rel.

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. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. 23 in its current form. at 183 (quoting Meyers v. Donnatacci , 531 A.2d 2d 398, 404 (N.J. Sizemore v.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

NOVEMBER 28, 2022

With the assistance of her employer, Dr. Moline put together an article: The article analyzed medical records and deposition transcripts for thirty-three anonymous individuals diagnosed with mesothelioma for whom Dr. Moline had conducted a medico-legal evaluation as part of tort litigation.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

APRIL 8, 2022

This often takes the form of lawsuits alleging that journal articles, continuing medical education, and other forms of scientific discussion are actionable “misrepresentations.” We said some time ago : [W]e’re sick and tired of plaintiffs alleging “you ghostwrote this” or “the article misrepresented the data.” Amersham Health, Inc. ,

Informed Consent 72

Informed Consent Governance 72