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
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...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
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
A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively...more
Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard....more
Medical ethicists and patient advocates are raising concerns about a big, costly, and often unsuccessful procedure that “pumps blood out of the body, oxygenates it, and returns it to the body, keeping a person alive for days,...more
The Food and Drug Administration (FDA) has taken the unusual step of limiting and restricting sales of the birth control medical device, Essure®, to healthcare providers who provide adequate risk versus benefit discussions...more
The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more
Connecticut state and federal courts faced a number of significant health care issues last year. We have summarized those cases that we think are particularly relevant to Connecticut hospitals, group practices and individual...more
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more
Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more
On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more
In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more