2 Important eSignature Use Cases: Informed Consent and Registration

Healthcare IT Today

We know that there are a lot of reasons for burnout in healthcare. One that sometimes people sweep under the rug a bit is the impact on productivity of outdated paper-based processes.

“Fertility Fraud” Legislation — A Turning Point for Informed Consent?

NEJM

Such legislation could herald an expansion of informed-consent doctrine State fertility-fraud laws prohibit deliberately misrepresenting the source of sperm, eggs, or embryos used to treat infertility.

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The Dr. Oz Paradox

Bill of Health

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. By Claudia E. Haupt.

New Evidence on Dementia, Identity, and Decision-Making

Bill of Health

In the prompt, a character named Robin had filled out an advance directive stating that she did not want medical treatment if she were to lose capacity (or, in the “control condition” participants were given more general information about her lifelong values). By James Toomey.

Ethics Education in U.S. Medical Schools’ Curricula

Bill of Health

The AAMC requires medical school graduates to “demonstrate a commitment to ethical principles pertaining to provision or withholding of care, confidentiality, informed consent.” By Leah Pierson. I recently argued that we need to evaluate medical school ethics curricula.

Call for Submissions – Symposium on Disability and Climate Change

Bill of Health

Announcements Bioethics Blog Symposia Call for Abstracts Disability Environment Health Law Policy Informed Consent Patient Care Petrie-Flom Center Public Health Publications Social Determinants of Health call for abstracts call for submissions climate climate change Ethics Law public policy

A New Theory for Gene Ownership

Bill of Health

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.

A Precautionary Approach to Touch in Psychedelic-Assisted Therapy

Bill of Health

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.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

Bill of Health

As a first step, we need our health agencies to keep the public informed. Physicians, particularly pediatricians, frequently prescribe off-label and use informed consent to provide the best care for their patients. By Fatima Khan.

We Need to Evaluate Ethics Curricula

Bill of Health

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. By Leah Pierson. Health professions students are often required to complete training in ethics.

How to Assess the Impact of Medical Ethics Education

Bill of Health

But many routine practices — assessing capacity, acquiring informed consent, advance care planning, and allocating resources, for instance — are. By Leah Pierson.

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

Bill of Health

In this post, I argue that young people should have the opportunity to consent to vaccines. Allowing children to consent to vaccinations may facilitate this end. Can Young People Consent to the Vaccine? Where Can Children Find the Right to Consent? By Victoria Kalumbi.

Bringing eConsent to the Intensive Care Unit

Healthcare IT Today

Director & General Manager, Patient Consent at IQVIA. The Challenge of Informed Consent in the ICU. Still, obtaining informed consent to participate in a clinical trial in these scenarios can be challenging.

How to Mitigate Ethical Challenges of AI-Driven Healthcare

Healthcare IT Today

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. . Koza ethics Healthcare AI Healthcare AI Ethics Informed Consent Natalie C.

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

Bill of Health

His writing will be informed by his experience with the war on drugs and community mental health, both as a patient and a clinician. (Clockwise from top left: Kwasi Adusei, Ismail Lourido Ali, Jonathan Perez-Reyzin, Dustin Marlan.).

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

Bill of Health

At that point, physicians and parents could make informed decisions as to whether to administer a COVID-19 vaccine or wait until they’ve received an EUA for young children. By Carmel Shachar. As trials stall and the omicron variant surges, the U.S.

Study: Decentralized and remote tech increases interest in clinical trial participation

Mobi Health News

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

Ivermectin controversy continues

Natalia Mazina

In my blog post “ Risk of dispensing ivermectin ,” I stressed the importance of obtaining informed consent prior to dispensing ivermectin. According to the complaint, the prescriber sought to obtain informed consent retroactively.

Long Trail for Extra Tissue Samples

HealthIT Answers

The concerns raised go to privacy and informed consent as the primary issues. By Matt Fisher - In healthcare, many layers always exist around seemingly each and every issue. The ongoing utilization of extra blood from newborn heel stick samples provides the latest example.

Bioethics Conference Poses Twenty-First Century Questions

Healthcare IT Today

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 […].

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1

Bill of Health

While EA is intended for treatment and is not research, federal regulations require IRBs to review and approve EA protocols and requests, the consent process, consent documents, surrogate consent, and related documents. By Alison Bateman-House, Hayley M.

Harms and Biases Associated with the Social Determinants of Health Technology Movement

Bill of Health

Referrals can simply involve providing the patient with information about a social service agency or community-based organizations that may have resources to address needs identified by the patient. Informed Consent and Refusal. By Artair Rogers.

Signant Health collaborates with Shanghai Mental Health Centre for neuroscience study

Mobi Health News

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).

Important practice-points for pharmacists independently initiating and furnishing Paxlovid

Natalia Mazina

iii) if no sufficient information is available to determine patient’s medical history and potential drug interaction, or if the pharmacist determines that taking Paxlovid may cause adverse reaction, the pharmacist must refer the patient for clinical evaluation.

A Brief History of Abortion Jurisprudence in the United States

Bill of Health

The first required a woman seeking an abortion to furnish “informed consent” prior to the procedure and stipulated that “she be provided with certain information at least 24 hours before the abortion is performed.” By James R. Jolin.

Adoption and the Meaning of Consent

Bill of Health

Adoption and abortion both rely on concepts of consent, each an exercise in autonomy. When I think of adoption consent, I think of Dawn’s case. Because the courts concluded that Dawn voluntarily consented, the adoption would stand. By Malinda L. Seymore.

Does the Right to Health Enhance Patient Rights?

Bill of Health

The State has never staged nationwide public debates followed by the creation of specific frameworks to address patient autonomy and informed consent. By Luciano Bottini Filho.

Weekly Roundup – September 3, 2022

Healthcare IT Today

Read more… Addressing Informed Consent Challenges in the ICU. Patients in intensive care are often unable to provide consent , which means they may miss opportunities to receive investigational treatments. Welcome to our Healthcare IT Today Weekly Roundup.

Sharecare Launches SaaS for Independent Decentralized Clinical Research

HIT Consultant

Within the self-service platform, easy-to-use tools allow researchers to establish and manage processes for electronic informed consent (eConsent) and adherence-based compensation, build and refine study protocols, and gather electronic patient-reported outcomes (ePROs).

FDA releases guidance for remotely acquiring data in clinical investigations

Healthcare IT News - Telehealth

"Sponsors are encouraged to engage with the DHT manufacturer or other parties in order to leverage any existing information, as appropriate, to support the DHT’s suitability for use in the specific clinical investigation," according to the draft guidance. The U.S.

FDA 152

Compliance Considerations For Telehealth Abortion Services

Healthcare Law Today

Similarly, the laws of the state where the patient is located will govern the informed consent process, the standard of care for the encounter, and any telemedicine-specific laws that a state may have adopted. In light of the U.S. Supreme Court's recent decision in Dobbs v.

Western states embark on new telehealth partnership

Healthcare IT News - Telehealth

Patient privacy and should be protected, the governors said, and patients should provide informed consent to receive care via the specific technology used to provide it.

Three Considerations for Health Care Providers After the Dobbs Decision

Healthcare Law Today

Many states have laws which restrict the way an abortion can be provided, including the type of provider who can provide the service, the location where the service may be provided, and the scope of informed consent required for the procedure.

Weekly Roundup – August 13, 2022

Healthcare IT Today

Artificial intelligence is revolutionizing healthcare, but organizations cannot ignore bias, informed consent, and other ethical challenges of using AI. Welcome to our Healthcare IT Today Weekly Roundup.

FQHCs: Proposed Guidance Addresses Health Center Delivery of Telehealth Services

Healthcare Law Today

The federal government is requesting comments on proposed guidance for federally qualified health centers (FQHCs) that provide services via telehealth.

3 Predictions for Post-COVID Clinical Trial Decentralization

HIT Consultant

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). Marc Leighton, VP of Product at Florence Healthcare.

Her First Colonoscopy Cost Her $0. Her Second Cost $2,185. Why?

Kaiser Health News

In a statement describing New London Hospital’s general practices, spokesperson Timothy Lund said: “Our physicians discuss the possibility of the procedure progressing from a screening colonoscopy to a diagnostic colonoscopy as part of the informed consent process.

ACA 99

Consent and COVID Testing of Employees

AIHC

Written By: Compliance Blogger This article addresses COVID testing and consent considerations for: healthcare organizations, nursing homes and business associates or non-healthcare workplaces. Workplace-based testing should not be conducted without the employee’s informed consent.

Inpatient telemedicine improves care and patient satisfaction at Howard University Hospital

Healthcare IT News - Telehealth

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. In March 2020, the number of new COVID-19 infections was rapidly increasing in Washington.

OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

Healthcare Law Blog

IRB approved protocols, enrollment criteria, informed consent process and other rules and regulations governing good clinical trial practice). Notably, the Requestor would not advertise the arrangement but only denote it on trial informed consent forms.

“The No Surprises Act” a/k/a “The Act that Continues Surprising Providers”

Health Law RX

The next day, April 5, 2022, CMS published these FAQs to provide general information regarding the technical legal standards of GFEs. Provide a one-page notice that includes information regarding patient protections against surprise billing.

List of Documents for Ambulatory Surgery Centers (ASCs)

Medisys Compliance

Informed consent. In addition, this pre-anesthesia evaluation should consider data from other assessments and collect information needed to complete selection and planning of anesthesia, safely administer anesthesia, and interpret findings of patient monitoring.

FDA Addresses the Role of Digital Health Technology in Clinical Trials

Healthcare Law Today

The applicable informed consent should clearly identify the data being collected and how that data will be used. The U.S.