AIHC

NOVEMBER 12, 2024

Written by Gabriella Neff, RHIA, CHA, CHC, CHRC, CHPC This past year, in 2024, revisions were made to clarify hospital guidelines related to informed consent specifically addressing UIEs (unconsented intimate exams) to patients while under anesthesia. OCR recently issued an FAQ focusing on this right. [6]

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Informed Consent HIPAA Compliance Hospitals 98

Bill of Health

JANUARY 29, 2024

As each contribution emphasizes, these oversights have ethical implications for research design, informed consent processes, and public communication. I hope that this symposium contributes to furthering conversations and generating new questions in the context of a broader “critical turn” within psychedelic studies.

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Informed Consent Bioethics Doctors 355

Health Law Advisor

SEPTEMBER 5, 2023

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. On August 15, 2023, the U.S.

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Bill of Health

FEBRUARY 8, 2022

Physicians, particularly pediatricians, frequently prescribe off-label and use informed consent to provide the best care for their patients. These are just two examples of ways that our process — not science — restricted vaccine access.

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COVID-19 COVID-19 Vaccine FDA Informed Consent 344

Hall Render

APRIL 16, 2024

Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum to state survey agency directors highlighting revisions and clarification to the Hospital Interpretive Guidelines for Informed Consent (the “Guidance”).

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Foster Swift

APRIL 16, 2024

In both circumstances, the former doctors carried out their sexual abuse under the guise of medical procedures and without the informed consent of their targets.

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Bill of Health

AUGUST 31, 2022

Without her knowledge or consent, her doctors derived from the cells the HeLa cell line — the world’s first immortal human cell line, worth billions and a driver of the biotechnology revolution. No doubt her doctors’ behavior was not consistent with today’s standards of informed consent. Lacks died in poverty.

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Bioethics Informed Consent Doctors 264

Bill of Health

FEBRUARY 2, 2022

More schools could consider using simulations of common ethical scenarios, where they might ask students to perform capacity assessments or seek informed consent for procedures. There are also questions about how to assess whether students will make more ethical decisions in practice.

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Informed Consent Bioethics Doctors Public Health 279

Health Law Checkup

JANUARY 20, 2022

To minimize their risk should a patient be exposed to COVID-19 while seeking medical care, health care providers should consider supplementing their informed consent process to include information about COVID-19 risks.

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Bill of Health

SEPTEMBER 23, 2022

The IRB is responsible for the review and approval of the cohort EA protocol, the informed consent form, the consent process, and other materials. Full committee review is appropriate. Single patient EA : Single patient EA involves one patient and one treating physician.

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Bill of Health

JULY 14, 2023

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S The World Health Organization supports this ban and in particular describes it as making informed consent impossible in the health care setting.

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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Informed consent includes the following basic elements: Description of clinical investigation.

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Mobi Health News

JULY 6, 2022

More than 80% of cancer patients and survivors who responded to the survey were willing to use the majority of remote interventions, like oral medications delivered to the home, electronic informed consent and wearables.

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Informed Consent 124

Bill of Health

JUNE 7, 2024

Informed consent: The informed consent process should address the potential for therapeutic misconception (participants mistaking research for clinical care) and clarify both what research results and what incidental findings will be offered to participants and how research findings differ from those produced in clinical care.

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Healthcare IT Today

SEPTEMBER 1, 2022

For this reason, the ability to provide the option for electronic informed consent (eConsent) to join a trial in place of traditional paper-based process plays a pivotal role in quickly enrolling the patient so that they may receive critical intervention as quickly as possible. The Challenge of Informed Consent in the ICU.

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Informed Consent Doctors Hospitals 98

Healthcare IT Today

AUGUST 9, 2022

The use of AI is revolutionizing the delivery of healthcare, but its use comes with significant ethical challenges that cannot be ignored, the most important of which involve bias and informed consent. . Another major ethical concern of AI use surrounds the principle of informed consent.

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Informed Consent FDA Hospitals Compliance 132

Healthcare IT Today

JUNE 22, 2021

All the standard ethical issues we talk about in medicine appear in the new genetic and biological research, often with greater urgency: safety and effectiveness, equitable access, privacy and informed consent, data sharing, and individual […].

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Mobi Health News

SEPTEMBER 13, 2019

Pennsylvania-based Signant Health (formerly CRF Health and Bracket), which provides a suite of electronic clinical outcome assessment (eCOA), eConsent and Patient Engagement solutions, announced that it will provide electronic informed consent for a significant neuroscience study by the Shanghai Mental Health Centre (SMHC).

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Informed Consent 99

Bill of Health

JUNE 29, 2022

But many routine practices — assessing capacity, acquiring informed consent, advance care planning, and allocating resources, for instance — are. And given the importance of these endpoints, it is worth determining whether ethics education improves clinicians’ decision making across these domains.

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Informed Consent Hospitals Bioethics Doctors 173

Compliancy Group

NOVEMBER 29, 2024

We review the fundamentals of HIPAA informed consent and discuss situations allowing HIPAA verbal consent to release information. The Law Behind HIPAA Informed Consent As the HIPAA Privacy Rule outlines, informed consent helps prevent the unauthorized use and disclosure of PHI.

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HIPAA Informed Consent Compliance Health Insurance 52

Healthcare IT News - Telehealth

JANUARY 3, 2022

Technology risks , such as those concerning physical well-being, privacy and informed consent. Verification, validation and usability of the technology. Using tools to collect data for clinical endpoints. Record protection and retention. Comments are due on the draft guidance by March 22. THE LARGER TREND.

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Bill of Health

DECEMBER 1, 2023

There’s a great value to be found in, say, shifting the conversation to informed consent regimes to address the transaction at the center of tissue provision in the first place. To be clear, I tend to agree that in this classification paradigm, it seems more trouble than it’s worth to go after ownership exclusively in human tissue.

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Informed Consent FDA 162

Natalia Mazina

AUGUST 16, 2022

Due to potential side effects and investigational nature of Paxlovid, pharmacists initiating and furnishing Paxlovid should require an informed consent and release signed by their patients taking Paxlovid. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid.

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COVID-19 Informed Consent FDA Licensing 98

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.

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American Medical Compliance

MARCH 11, 2024

They include principles of patient care, confidentiality, and informed consent. Documenting this consent, along with a clear explanation of the treatment risks, benefits, and alternatives, is imperative. Moreover, the Dental Practice Act specifies the criteria and procedures for obtaining and maintaining licensure.

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Regulatory Compliance Compliance ADA Informed Consent 88

Bill of Health

MARCH 6, 2024

Canada’s MAID law has some safeguards to prevent patients from being coerced into MAID, such as requiring cognitive capacity to consent, voluntary informed consent, assessors and witnesses who are independent of each other and who have no conflicts of interest, and waiting periods between different stages of the process.

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Informed Consent Governance Bioethics 133

Healthcare IT Today

MAY 18, 2023

Ethical Considerations Around Patient Consent The use of large language models in telemedicine may require obtaining patient consent for collecting, storing, and using their personal health information. Ensuring Informed Consent Develop clear and transparent policies regarding patient consent, data collection, and data usage.

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Telemedicine Informed Consent Patient Satisfaction Doctors 115

Bill of Health

FEBRUARY 21, 2024

Health Care Proxy Before the child is born, the student will recall that medical procedures require informed consent. These procedures requiring informed consent will include the labor and delivery process. The law student will be on the lookout for decisions requiring consent.

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Bill of Health

FEBRUARY 20, 2023

By Nina Kohn and Irina D. Manta This month, New York became the latest to join the growing list of states that have ended their requirements for routine masking in hospitals and other healthcare settings.

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Hospitals COVID-19 Malpractice Informed Consent 364

Bill of Health

JULY 18, 2022

By James Toomey. In my paper Narrative Capacity (recently published in the North Carolina Law Review ), I argue, among other things, that the legal system’s recognition of personal decision-making should be a function of personal identity, not (as it currently is) of an individual’s momentary cognitive functioning.

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Bioethics Informed Consent Governance 363

Healthcare IT News - Telehealth

MAY 24, 2021

Staff addressed questions related to documentation of the visits, informed consent, government regulations, physician licensing and supervision of residents, and developed forms in the EHR. Multi-way communication. "The telemedicine system currently is not integrated with other systems," Dawson said.

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Patient Satisfaction Telemedicine Hospitals COVID-19 183

Bill of Health

MARCH 9, 2022

Amid accelerating interest in the use of psychedelics in medicine, a spate of recent exposés have detailed the proliferation of abuse in psychedelic therapy, underscoring the urgent need for ethical guidance in psychedelic-assisted therapies (P-AT), and particularly relating to touch and consent.

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Bioethics Informed Consent Licensing Doctors 359

Bill of Health

JANUARY 24, 2022

By Carmel Shachar. As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

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COVID-19 Vaccine COVID-19 FDA Hospitals 69

Healthcare IT Today

JANUARY 16, 2023

The model works by garnering informed consent to collect health data on behalf of people participating in clinical research from any healthcare organization touching their care. Crescendo Health is an innovative digital health company that is transforming the way patient health data is collected and used to advance clinical research.

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Natalia Mazina

MARCH 13, 2022

In my blog post “ Risk of dispensing ivermectin ,” I stressed the importance of obtaining informed consent prior to dispensing ivermectin. On the same note, a legal action was filed in Arkansas against a prescriber (among others) for treating patients (inmates) with ivermectin without prior informed consent.

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Informed Consent 52

Bill of Health

MARCH 15, 2023

By Sarah Gabriele Doctors are now using social media platforms to spread medical knowledge and to interact with the communities that they are actively building. This trend poses new ethical questions for physicians who want to create and engage with their communities on social media.

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Doctors Telemedicine COVID-19 Informed Consent 341

Healthcare IT Today

OCTOBER 20, 2023

Healthcare providers offering CPaaS must also follow general CPaaS security standards and ensure continuous auditing to protect sensitive health information. Obtain Patient Consent It’s essential to obtain informed consent from patients when using their data for healthcare CPaaS applications.

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HIPAA Informed Consent Nurses Compliance 121