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 One that sometimes people sweep under the rug a bit is the impact on productivity of outdated paper-based processes.

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.

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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.

Adding COVID-19 to the informed consent process: A Q&A for health care providers

Health Law Checkup

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

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.

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.).

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.

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 […].

Covid-19 Put the Spotlight on eConsent, and Rightfully So

Perficient

Informed consent, an integral part of clinical research, ensures that clinical trial participants are well-informed about all the relevant aspects of the clinical trial and that their participation is voluntary.

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.

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).

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

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.

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 87

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.

“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.

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.

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.

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.

Overcoming Key Hurdles in Decentralized Trials with Better Education

HIT Consultant

In addition, informed study staff will be better equipped to answer patient questions, provide context for study procedures, and help guide patients on their study journey, thereby improving the patient experience. Robert Geckeler, ScienceMedia Product Director.

Is the Smartphone Key to Unlocking Frictionless Patient Registration?

HIT Consultant

Patients are increasingly expecting a smooth, easy, consent-driven experience with their healthcare providers that rivals what they can do in other aspects of their lives. The ideal digital identification solution merges simple, seamless interfaces with advanced privacy and consent features.

Telehealth for Behavioral Healthcare

Verisys

Clear Communication on Consent and Fees. The APA advises that clients/patients may have varying degrees of technological skills or ability to thoroughly read and understand informed consent and billing. Accurate, compliant, and complete information.

Risks of dispensing ivermectin

Natalia Mazina

In addition to checking the dosage and reviewing patient’s current medication intake, the pharmacist should educate and inform the patient (in writing) of the potential side effects and risks associated with taking ivermectin.

FDA 68

SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s). USB or CD), and the frequent electronic exchange of medical device-related health information. By Laurel Hacche & Debra Cortner SQA Associates. SQA Regulatory Surveillance Summary 2022 – Spring. Agência Nacional de Vigilância Sanitária (ANVISA).

FDA 63

New York Doubles Down on Telehealth

NY Health Law

diminished quality of care, increased opportunity to violate scope of practice or informed consent laws, etc.) As policymakers have responded to the COVID pandemic, they have implemented a variety of changes that create tremendous opportunities in the post-COVID world.

Personalized Medicine: Consumer Concerns About Coverage, Affordability and Privacy

Health Populi

The poll results are published in Public Perspectives on Personalized Medicine , with the top-line finding that life science industry innovators must better educate and inform consumers on the opportunities and benefits of personalized medicine. On this point, only 10% of Americans were aware of GINA, the Genetic Information Nondiscrimination Act, which is in place to prevent employers or insurers from asking for genetic test results for employment and/or coverage decisions.

Is Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical Operations.

C&M Health Law

For any company interacting with large sets and various streams of information, this can represent a significant exposure to risk. 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. This article was originally published in Corporate Compliance Insights.

Update on No Surprises Act 2022

AIHC

The information below is not legal or consulting advice, but is provided as education and offers links to additional resources. patient must receive notice of and consent to being balance billed by an out-of-network provider). Download the CMS Model Notice and Consent forms.

Vlog: Powering Efficient Decentralized Trials With Diversity in Mind | Jeeva Informatics

Perficient

A particular sponsor may only be looking for a remote informed consent as a service offering. Param Singh: Hello, everyone. My name is Param Singh. I’m Director of the clinical operations solution practice here at Perficient life sciences.

SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

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.

HIRING THE HEALTH CARE LAWYER

Matt Kinley

Health Information Technology for Economic and Clinical Health Act (HITECH). Informed Consent matters. MAKE SURE YOUR NOT GETTING RIPPED-OFF BY THE BIG LAW FIRM. The Problem. All businesses need to be careful with hiring and paying attorneys.

Library Management in Oracle InForm

Perficient

There is inherent functionality in Oracle InForm Central Designer (CD) which makes copy groups somewhat obsolete. The InForm Process. For example, a typical screening event may include forms for informed consent, inclusion/exclusion criteria, physical exam, vitals, and screening status. — Perficient’s deep clinical data management experience makes us the ideal partner to support your use of Oracle InForm.

GDPR: Data Privacy Laws in Financial Services

Perficient

Personal data of an individual may not be processed unless he/she has provided informed consent to it or there is a legal basis to do so. Pseudonymization is the process required when personal data is stored, to transform the data in such a way that the resulting data cannot be attributed to a specific data subject without the use of additional information.

Subject Screening with Robotic Process Automation: Life Sciences

Perficient

As soon as his status changes to approved, he receives a welcome notification and a request to complete the informed consent process. My last blog analyzed site monitoring, and how robotic process automation can enhance it. My next blog discusses life science subject screening and how robotic process automation (RPA) can assist.

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

He also testified that even if the warning label contained all of the information suggested by [plaintiff’s] expert, he would still have prescribed the medication for [plaintiff]. that he had considered the information that Plaintiff claims was wrongfully omitted. . .,

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

Causation was defeated, in part, by the prescribing physician’s testimony that “he did not consider the information contained in the [updated] label to be significant enough to change his prescribing practices.”

Guest Post – Curling Up With a Good Reasonable Alternative Design Opinion

Drug & Device Law

Second, the case also involved a lawsuit against the plaintiff’s regular gynecologist, who recommended a sling procedure during an office visit and referred the plaintiff to the implanting physician, for failing to obtain proper informed consent for the defendant’s implant.

How Can A Plaintiff Prove Warnings Causation? The Ninth Circuit Wants To Know

Drug & Device Law

Or can the plaintiff establish causation by showing that the physician would have informed the plaintiff of the stronger warning and that a prudent person in the patient’s position would have declined treatment? If my doctor had informed me, I would not have consented to the treatment.

No DTC Advertising Exception to Learned Intermediary Rule in Washington

Drug & Device Law

Doctors are charged with discussing the risks and benefits of treatment and obtaining informed consent from their patients. It has been 23 years since New Jersey adopted a direct-to-consumer advertising exception to the learned intermediary rule.