Healthcare Law Today

JANUARY 20, 2022

The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device. The applicable informed consent should clearly identify the data being collected and how that data will be used. FDA Draft Guidance Recommendations.

FDA 52

FDA Informed Consent 52

AIHC

SEPTEMBER 5, 2023

In many states, the definition of telemedicine and/or telehealth stipulates that the delivery of services must occur in “real time,” automatically excluding store-and-forward as a part of telemedicine and/or telehealth altogether. Obtaining informed consent with your patient is typically done before the first appointment.

COVID-19 59

COVID-19 Telemedicine Informed Consent Compliance 59

MedTrainer

DECEMBER 7, 2023

Telehealth Law Idaho’s Virtual Care Access Act , passed in 2023, broadens virtual care’s definition to include various technology-enabled services like telemedicine and remote monitoring, considering care as rendered at the patient’s location.

Compliance 52

Compliance Licensing Compliance Officers Informed Consent 52

HIPAA Journal

JANUARY 16, 2023

One of the reasons why some people approach the topic of AI in healthcare with a degree of apprehension is that different sources offer different definitions of AI. To quote Microsoft´s definitions of the two terms: . It is also the case that some sources confuse AI with Machine Learning (ML), which strictly speaking is a subset of AI.

Governance 68

Governance HIPAA World Health Informed Consent 68

AIHC

JANUARY 5, 2022

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. Track results – are your processes working?

Medical Billing 52

Medical Billing Health Insurance Hospitals Medicare 52

SQA

APRIL 30, 2021

generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. Used/referenced in multiple IPEC guides. ANSI Standard, USP).

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Healthcare IT Today

JUNE 13, 2024

Enhancing the interpretability of AI models and promoting informed consent empower patients to understand and control how their data is used in AI applications. Definitely a lot of things to be looking out for when you integrate AI into your organization!

Governance 80

Governance HIPAA Hospitals Informed Consent 80

Healthcare IT Today

DECEMBER 22, 2023

While it sounds reasonable, the definition of “responsible use” is not provided. A key component placing providers at risk is the lack of informed consent by patients to use these models to drive their care. Government’s AI Executive Order: A Step Forward or Falling Short?

US Department of Health and Human Services 112

US Department of Health and Human Services Nurses Informed Consent Doctors 112

Healthcare Law Today

DECEMBER 12, 2022

Yes, I definitely echo what Mark says, and to not, kind of repeat everything, I would describe it, really, as evolving and heightened, right? They want companies to disclose the relevant information. They want to make sure that the consumer has given their express and informed consent, and then, of course, making cancellations easy.

Telemedicine 49

Telemedicine Fraud Governance Compliance 49

Healthcare Law Blog

AUGUST 9, 2023

The bill amends the existing Women’s Right to Know Act with the expansion of the definition of abortion. 13] Kansas : H.B. 2264 took effect July 1, 2023. 15] District Court Judge K. 20] North Carolina : Several provisions of S.B. 20 , passed by the North Carolina legislature in May of this year, took effect on July 1, 2023.

Licensing 52

Licensing Informed Consent Nurses FDA 52

Bill of Health

JUNE 18, 2024

While “responsible” is not defined, one plausible definition might be “defensible to a jury.”) Shared information While the OurNotes initiative represents a model for co-creation of information with clinicians, important non-traditional inputs that should be shared are still generally absent from the record.

Doctors 218

Doctors HIPAA Informed Consent Health Insurance 218

Drug & Device Law

DECEMBER 21, 2023

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. The penalty did not hold up, but the duty did.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

MAY 25, 2023

Another motion reflected Bexis original position (but wasn’t Bexis’ motion), that the Institute should prepare black letter, comments and reporters’ notes for both sides of this issue, similarly to the manner in which the same draft handled the question of patient-oriented versus physician-oriented standards for informed consent.

Informed Consent 59

Informed Consent Malpractice Governance 59

Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Nor could a trade association be liable for common-law negligence in either jurisdiction: “[P]ublication of testing standards and ingredient definitions did not create any legal duty to the general public.”

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

SEPTEMBER 9, 2022

Two cases are cited in connection with the court’s definition of a novel test for proximate cause for a prescription medical device warnings claim. Larkin did not discuss the standard for proximate causation or suggest, as Thacker implies, that informed consent is part of the inquiry. The first is Larkin v. Pfizer, Inc. ,

Doctors 59

Doctors Informed Consent 59

Drug & Device Law

NOVEMBER 28, 2022

Moline obtained from her employer’s institutional review board to conduct the article was structured to “reference[] federal regulations governing human subject research,” while simultaneously “waiv[ing] the requirement that Dr. Moline obtain informed consent from the individuals whose cases she planned to study.”

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

MARCH 9, 2022

The plaintiff expert intended to opine that the defendant’s premarket testing was inadequate, that the mesh device labeling inadequately informed doctors, that the labeling precluded patient informed consent, and that the inadequate labeling meant that the mesh device was “misbranded” and “adulterated.” No Informed Consent.

Informed Consent 64

Informed Consent FDA Doctors Licensing 64