This issue’s “Legal Briefing” column covers legal developments pertaining to informed consent. Not only has this topic been the subject of recent articles in this journal, but it also been the subject of numerous public and professional discussions over the past several months.Legal developments concerning informed consent can be usefully grouped into nine categories: 1. General disclosure standards in the clinical context2. Shared decision making3. Staturorily mandated abortion disclosures4. Staturorily mandated end-of-life counseling5. Other staturorily mandated subject-specific disclosures6. U.S. Food and (...) Drug Administration (FDA) labeling and federal pre-emption of state informed consent law7. Relaxed informed consent for HIV testing8. General disclosure standards in the research context9. Issues on the horizon. (shrink)

This “Legal Briefing” column covers recent legal developments involving patient decision aids. This topic has been the subject of recent articles in JCE. It is included in the 2010 Patient Protection and Affordable Care Act. And it has received significant attention in the biomedical literature, including a new book, a thematic issue of Health Affairs, and a recent article in the New England Journal of Medicine. Moreover, physicians and health systems across the United States are increasingly integrating decision aids into (...) their clinical practice. Both federal and state laws play a significant role in promoting this expanded use. On the other hand, concerns about liability could stymie development and implementation. We categorize legal developments concerning patient decision aids into the following five sections:1. Development of decision aids2. Effectiveness of decision aids3. Federal regulation of decision aids4. State regulation of decision aids5. Legal concerns regarding decision aids. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving the Patient Self-Determination Act . Enacted in the wake of the U.S. Supreme Court’s Cruzan decision in 1990, the PSDA remains a seminal event in the development of U.S. bioethics public policy, but the PSDA has long been criticized as inadequate and ineffective. Finally, recent legislative and regulatory changes promise to revitalize and rejuvenate it. The PSDA has been the subject of recent articles in The Journal of Clinical Ethics.I categorize (...) new legal developments concerning the PSDA into the following eight sections:1. Background and History2. Rules and Requirements3. Criticism and Challenges4. Failed Efforts to Amend the PSDA5. Personalize Your Care Act of 20136. New Regulations7. New Regulatory Guidance8. Expanded Enforcement. (shrink)

Patient decision aids enable patients to be better informed about the potential benefits and harms of their healthcare options. Certification of patient decision aids at the national level in the United States is a critical step towards responsible governance—primarily as a quality measure that increases patients’ safety, as mandated in the U.S. Patient Protection and Affordable Care Act (PPACA). Certification would provide a verification process to identify conflicts of interest that may otherwise bias the scientific evidence presented in decision aids. (...) Certification also benefits clinicians who may otherwise face malpractice claims based on harm to patients caused by possible reliance on patient decision aids that are inaccurate, incomplete, or presented in a manner that biases the patient’s decision. Existing work by the International Patient Decision Aid Standards Collaboration could guide the establishment of a certification process within the U.S. This article argues for national certification of patient decision aids and discusses how that may be achieved. (shrink)

For millennia physicians were admonished to obscure the details of patients’ illnesses and poor prognoses. The Hippocratic ethic precludes physicians from including patients in medical decisionmaking. That ethic demanded of doctors that they “[p]erform [their duties] calmly and adroitly, concealing most things from the patient … revealing nothing of the patient's future or present condition.”.

The Wisconsin Supreme Court, after adopting the doctrine of the objective patient standard, expanded it in bold and innovative ways over nearly four decades, until the Wisconsin legislative and executive branches drastically reversed this course. The saga has implications for other jurisdictions considering adoption or expansion of the objective patient standard doctrine.