Bill of Health

APRIL 18, 2023

The enormous ‘data hunger’ of medical AI may also affect medical privacy, and the opaque nature of many AI applications may put existing health practices and other patients’ rights under pressure, such as the provision of information, informed consent, and legal redress.

Informed Consent 144

Informed Consent Elder Care COVID-19 Doctors 144

Natalia Mazina

SEPTEMBER 20, 2021

This month, the American Medical Association, American Pharmacist Association, and American Society of Health-System Pharmacists issued a joint release urging prescribers and pharmacists to stop ordering, prescribing, and dispensing ivermectin to prevent or treat Covid-19 outside of clinical trials.

COVID-19 85

COVID-19 FDA Informed Consent Doctors 85

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. SARS-CoV-2 (COVID-19) continues to be a health risk to be mitigated by health care institutions and at the workplace.

COVID-19 52

COVID-19 Nursing Homes Informed Consent Nurses 52

Bill of Health

MARCH 15, 2023

This picture rapidly changed with the COVID-19 pandemic and the increased use of telemedicine, creating the necessity to revisit the classic standard for establishing a doctor-patient relationship.

Doctors 341

Doctors Telemedicine COVID-19 Informed Consent 341

Bill of Health

FEBRUARY 15, 2023

Wolf With our recent (and continuing) experience of the devastating COVID-19 global pandemic, one might think that our collective appreciation for public health efforts and the people advancing those efforts would be high. By Leslie E.

Public Health 222

Public Health COVID-19 World Health Informed Consent 222

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. Higher rates of use of telehealth are now standard in many practices since the coronavirus disease 2019 (COVID-19) pandemic.

COVID-19 59

COVID-19 Telemedicine Compliance Informed Consent 59

Health Populi

JULY 31, 2023

While technology has become a “deeper and more integral part of people’s lives,” the analysis recognized, “these deeper ties between individuals and technology generated mixed effects and perhaps even more mixed feelings” in and in the wake of the COVID-19 pandemic.

Informed Consent 62

Informed Consent COVID-19 Health Insurance HIPAA 62

Hall Render

SEPTEMBER 14, 2023

This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices.

FDA 40

FDA Informed Consent COVID-19 Fraud 40

HIT Consultant

NOVEMBER 17, 2021

As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Further underscoring this trend, 93% of sites also reported that they would allow sponsors or CROs to conduct remote monitoring, compared to 74% pre-COVID.

COVID-19 97

COVID-19 Pharmaceutical Industry Informed Consent Compliance 97

HIT Consultant

NOVEMBER 2, 2021

This strategy will let patients take the lead in double-checking their own data for errors and providing informed consent for data access across providers, all from their own personal devices. The ideal digital identification solution merges simple, seamless interfaces with advanced privacy and consent features.

Informed Consent 98

Informed Consent Patient Satisfaction COVID-19 98

Verisys

JANUARY 27, 2022

COVID has impacted every aspect of daily life, and these changes have affected people’s mental health, making telehealth services for behavioral health more important than ever. Telepsychiatry services where digital intervention is allowed include: Treatment of COVID-related symptoms. Clear Communication on Consent and Fees.

US Department of Health and Human Services 52

US Department of Health and Human Services Telemedicine Licensing Informed Consent 52

Bill of Health

AUGUST 29, 2022

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated , and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19. [1]. Youth in the foster care system and those who are justice-involved face additional challenges during the ongoing COVID-19 pandemic.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Healthcare IT News - Telehealth

AUGUST 7, 2020

Governors Jay Inslee of Washington, Kate Brown of Oregon, Steve Sisolak of Nevada and Jared Polis of Colorado say their states, just as they have with other areas of the COVID-19 pandemic, will be collaborating on telehealth strategy. Confidentiality.

COVID-19 215

COVID-19 Informed Consent Governance Fraud 215

SQA

APRIL 30, 2021

Commission Extends Transparency and Authorization Mechanism for Exports of COVID-19 Vaccines, 11 March 2021. The EC has extended until the end of June 2021 the transparency and authorization mechanism for COVID-19 vaccine exports. The mechanism provides for authorizations of exports of COVID-19 vaccines outside the EU.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Healthcare Law Today

DECEMBER 12, 2022

Well, first, telemedicine really advanced during the COVID pandemic, where a lot of people found it very useful in a way to stay well by using telemedicine. One thing I’m looking out for is how many states draw back on telemedicine now that the COVID crisis is mostly over. They want companies to disclose the relevant information.

Telemedicine 49

Telemedicine Fraud Governance Compliance 49

SQA

FEBRUARY 15, 2023

Until EUDAMED is brought fully online, a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR (see MDCG 2022-19). Decentralization is enabled by the advancement of digital tools, telemedicine, and more mobile and local healthcare.

US Department of Health and Human Services 40

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

HIT Consultant

APRIL 27, 2022

Prior to COVID , major technological transformation initiatives were already underway at many clinical trial sites, sponsors, and contract research organizations (CROs.) By the end of the year, I expect the majority of sites will have an electronic Investigator Site File (eISF) and electronic informed consent (eConsent).

Informed Consent 98

Informed Consent Doctors Hospitals COVID-19 98

HIPAA Journal

JANUARY 16, 2023

Drug development processes can be significantly accelerated with AI technologies that quickly extract meaningful information from large datasets to predict harmful interactions with existing drugs, improve the quality of clinical trials, and reduce time to approval.

Governance 65

Governance HIPAA World Health Informed Consent 65

Hall Render

FEBRUARY 10, 2023

billion since pandemic U.S. leading cause of death is heart disease, Alabama’s matches that Alabama lawmakers put temporary hold on $1 billion contract for prison healthcare New rolling NICU a ‘game changer’ for critical babies in Alabama More than a dozen Alabama hospitals at immediate risk of closing; officials say hospitals suffer $1.5

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Kaiser Health News

NOVEMBER 27, 2023

From abortion to covid-19 vaccines, Newsom and DeSantis could not be further apart. DeSantis has led his state to restrict abortion and gender-affirming care and to ban covid-related mask and vaccine mandates. The Sunshine State’s covid-19 vaccine booster rate for residents age 5 and older is 12.4%.

COVID-19 Vaccine 107

COVID-19 Vaccine COVID-19 Medicaid Medicaid 107

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. COVID-19 was such a health emergency, and the PREP Act is why, despite an appalling degree of antivaxx agitation out on the hustings, there has been next to no actual product liability litigation concerning COVID-19 vaccines.

FDA 105

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

Drug & Device Law

FEBRUARY 29, 2024

6, 2024), the Central District of California looked at the PREP Act in the usual context in which we deal with preemption: A tort lawsuit (involving product liability and related state law tort claims) against a medical product manufacturer (here, the manufacturers of the COVID 19 antiviral medications remdesivir and tocilizumab).

COVID-19 59

COVID-19 Informed Consent FDA Governance 59

Drug & Device Law

FEBRUARY 26, 2024

15, 2024) (“ CHD ”), the Third Circuit affirmed the right of a publicly supported university to require COVID-19 vaccination as a prerequisite to its students’ in-person attendance. First of all, only one of the plaintiffs ever sought vaccination, so the rest were never entitled to informed consent at any time.

COVID-19 52

COVID-19 COVID-19 Vaccine Informed Consent FDA 52