Hall Render

SEPTEMBER 14, 2023

The guidance describes DCT-specific considerations that may not be present in site-based clinical trials, and how sponsors can approach such issues. DCTs often present novel problems that sponsors conducting site-based clinical trials have not previously encountered.

FDA 40

FDA Informed Consent COVID-19 Fraud 40

Healthcare Law Blog

MARCH 17, 2022

Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented.

US Department of Health and Human Services 52

US Department of Health and Human Services Informed Consent Medicare Medicare 52

AIHC

SEPTEMBER 5, 2023

The lack of multistate licensure presents a barrier to telehealth because providers must obtain and uphold licensure (and the associated medical education and financial obligations) in multiple states. Obtaining informed consent with your patient is typically done before the first appointment.

COVID-19 59

COVID-19 Telemedicine Compliance Informed Consent 59

C&M Health Law

JUNE 15, 2021

bribery, fraud, misuse). Health Insurance Portability and Accountability Act (HIPAA) can present several areas of exposure. 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

Healthcare Law Today

DECEMBER 12, 2022

Maureen has extensive experience handling malicious insider matters ranging from employee fraud, embezzlement, and misappropriation to breaches of non-solicitation, non-compete and confidentiality agreements. I think you see that, as Mark pointed out, with the fraud alert. regulatory focus over the next couple of years. Mark Josephs.

Telemedicine 49

Telemedicine Fraud Governance Compliance 49

HIPAA Journal

JANUARY 16, 2023

AI is used by the finance industry to detect potential credit card fraud. Although specific concerns differ by organization, the concerns can generally be categorized as informed consent to use data, safety and transparency, algorithmic fairness, and data privacy. .

Governance 65

Governance HIPAA World Health Informed Consent 65

Drug & Device Law

DECEMBER 21, 2023

The logic of the consumer fraud claim made no sense. Allegedly, consumers deprived of efficacy (not risk) information had their informed consent rights infringed, which in the case of persons without the genetic difference, meant that they were spared the expense of undergoing negative genetic testing.

FDA 52

FDA Fraud Informed Consent 52