Exploring Digitization of Health and Medical Data and Records Part Two
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
The Evolution of Informed Consent in U.S. Courts
What patients misunderstand about their right of informed consent
Though responsible and ethical use of artificial intelligence (AI) has been a hot topic for the past few years, there has not yet been significant adoption of laws or regulations aimed specifically at regulating the use of AI...more
Overlapping surgeries is a practice that has been used for many years by healthcare providers (such as hospitals and surgical centers). This practice generally refers to situations where one lead attending surgeon is...more
Idaho’s new parental consent law took effect July 1, 2024. Under the new law: “[A]n individual shall not furnish a health care service or solicit to furnish a health care service to a minor child without obtaining the...more
Hospitals should not delay in reviewing and revising their surgical informed consent forms and policies. On April 1, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued new guidance regarding informed consent...more
New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more
On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”), Center for Clinical Standards and Quality/Quality, Safety & Oversight Group, issued new...more
On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform...more
The new rules about chaperones for physicians in private practice (not hospitals or hospital-employed physicians) go into effect October 1, 2023. The rule is promulgated by the Medical Examining Board (MEB), which does not...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. 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...more
The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more
On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more
The Idaho legislature has amended Idaho’s Medical Consent Act. The redlined changes are shown here. Effective July 1, 2023, the rules for medical consents in Idaho are as follows: 1. Need for Informed Consent. As a...more
Idaho’s new Virtual Care Access Act (the “Act”) amends Idaho’s existing law to make it easier to render telehealth in Idaho effective July 1, 2023. The requirements of the new Act are summarized below....more
Significant health care cases of 2022 included a surprise billing unfair trade practices case, a class action recognizing a patient’s constitutionally protected interest in their inpatient classification and a ruling...more
In a win for healthcare providers, the Pennsylvania Supreme Court confirmed in Mitchell v. Shikora that evidence of the risks and complications of a surgical procedure may be admissible in a medical negligence case that does...more
On August 20, 2015, the Colorado Medical Board (the Board) adopted Policy 40-27, which sets forth important new guidelines for providers delivering healthcare services via telehealth technologies, including the ability to...more
The Maine Board of Licensure in Medicine enacted new guidelines governing the practice of telemedicine and the use of technology to deliver health care services. Effective June 2014, Maine’s guidelines expand upon prior Board...more
The Colorado Medical Board proposed updated draft guidelines for the delivery of healthcare services via telehealth, as well as remote prescribing for new patients. Recognizing that “using telehealth technologies in the...more
This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more
The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more
Many patients misunderstand what "informed consent" is all about. They often believe it's about signing a form ahead of surgery that acts as a waiver against any rights they may have for legal recourse if the surgery goes...more
Originally published in American Health Lawyers Association's MedStaff News - November 2012. Much ink has been spilled over the last several years concerning the growth of telemedicine. Taking advantage of high-tech...more