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This study uses Department of Health and Human Services data to analyze surveillance of electronic health records for patient safety issues to identify those with a potential for patient harm, and the frequency of these issues.

On May 2, 2019, the US Department of Health and Human Services (HHS) and Office of Civil Rights (OCR) released a final rule that heightens the rights of hospitals and health workers to refuse to participate in patients’ medical care based on religious or moral grounds. The rule covers OCR’s authority to investigate and enforce violations of 25 federal “conscience protection” laws. Tied to the US Constitution’s spending power, the rule applies to state and local governments, as well as public and private health care professionals and entities if they receive federal funds such as Medicare or Medicaid. The rule applies to a range of important health services such as abortions, sterilizations, assisted suicide, and advance directives — extending to sex reassignment and HIV treatment.

On July 7, Tom Price, MD, secretary of the Department of Health and Human Services (HHS), announced the appointment of Brenda Fitzgerald, MD, as the 17th director of the Centers for Disease Control and Prevention (CDC). To this position, Dr Fitzgerald brings her experience as Commissioner of the Georgia Department of Public Health, a role in which she championed infant health and survival, tobacco control, and obesity prevention. Other significant choices of individuals to head agencies that affect the public’s health include the recent nomination of Jerome Adams, MD, MPH, as surgeon general, and reappointment of Francis Collins, MD, PhD, as National Institutes of Health director. While such choices appear to bode well for public health, how well these agencies and others will be funded for programs affecting public health both inside and outside the United States matters enormously. What has the Trump administration signaled about its intentions in its proposed budget?

Original scientific reports in peer-reviewed journals are the cornerstones of new medical knowledge. Yet medical journalism, unlike research, is not a science but rather, like medical practice, a mix of art and science. All journals face the continuing challenges of providing their readers with information they can trust, improving their systems for evaluating manuscripts, and dealing with increasing concerns about financial and intellectual conflicts of interest. Diagnosing the ills of biomedical publications and advancing solutions are the missions of the International Congresses on Peer Review and Biomedical Publication, the seventh and most recent of which was held in Chicago in September 2013, organized by The JAMA Network and the BMJ and once again led by Drummond Rennie, MD.

This article focuses on levonorgestrel emergency contraception known as Plan B One-Step and the decision to make it available over-the-counter for all women of childbearing age. It describes the emergency contraceptive how it works and the politics involved in the decision to make it available as a nonprescription drug.

MANY RACIAL AND ETHNIC MINORITIES, PEOPLE with limited English-language proficiency, people with disabilities, and other commonly underserved populations face unique health challenges, have reduced access to health care and insurance, and often experience poorer health throughout their lives. In the past, identifying disparities and effectively monitoring efforts to reduce them have been limited by a lack of specificity, uniformity, and quality in data collection and reporting procedures. The importance in the documentation of disparities and the critical importance of rich data systems to understand and track interventions to reduce health disparities among population subgroups have been called for, dating back to the 1985 Report of the Secretary’s Task Force on Black and Minority Health and the recent Institute of Medicine report Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement. As noted in those reports, consistent methods for collecting and reporting health data will help better characterize the nature of health problems in underserved populations. The Department of Health and Human Services (HHS) has adopted new data standards for the collection of race, ethnicity, sex, primary language, and disability status for selfreported data collected from population-based health surveys. Data standards were developed in accordance with section 4302 of the Affordable Care Act. That section of the act focuses on the standardization as well as collection, analysis, and reporting of health disparities data. It requires the HHS secretary to establish data collection standards for race, ethnicity, sex, primary language, and disability status. The law requires that, once established, these data collection standards be used in national population health surveys. The law also gives the secretary the authority to require collection of additional demographic data on departmental population health surveys and to develop appropriate additional data collection standards. Even though data collection will not reduce disparities, having such data is fundamental to the department’s efforts to understand the causes of health disparities, design effective responses, and evaluate progress in reducing disparities. The new data standards for race, ethnicity, sex, primary language, and disability status represent a critical step in uniformly collecting data needed to track disparities and to ensure continued progress in efforts to reduce disparities.

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) has proposed sweeping revisions to the federal regulations for the protection of human research participants. The goal is to “enhance protection while simultaneously eliminating unreasonable burdens.” Although the goal is admirable, some changes intended to remove unnecessary regulatory burdens may allow serious risks (ie, the probability of harm is significant, not merely possible or conceivable), particularly to highly vulnerable participants (ie, participants’ ability to give free and informed consent is seriously compromised). In this Commentary, 3 major issues in the Advance Notice of Proposed Rule-Making (ANPRM)—ensuring riskbased protections, institutional review board (IRB) reviews of multisite studies, and informed consent—are discussed. New policies to reduce regulatory burdens should be coupled with procedures to protect participants if research poses serious risks, involve highly stigmatizing conditions, or include significantly vulnerable participants.

In February 2014, the Department of Health and Human Services (HHS) issued a landmark ruling allowing patients direct access to completed medical laboratory reports.1 The ruling took effect April 7, 2014, and gives laboratories 180 days from that date to comply. Although this recent change to the Clinical Laboratory Improvement Amendments (CLIA) empowers patients by removing access barriers to personal health information, it raises a variety of clinical and ethical questions involving practitioners, patients, and society. To capture the benefits of the change and to minimize potential challenges, clinicians will need to proactively counsel patients to ensure that patients do not engage in detrimental self-interpretation of test results, especially because of the abundance of information and misinformation made available through the Internet and other sources.2

Health information privacy is important in US society, but existing federal and state law does not offer adequate protection. The Department of Health and Human Services, under powers granted by the Health Insurance Portability and Accountability Act of 1996, recently issued a final rule providing systematic, nationwide health information privacy protection. The rule is extensive in its scope, applying to health plans, health care clearinghouses, and health care providers (hospitals, clinics, and health departments) who conduct financial transactions electronically ("covered entities"). The rule applies to personally identifiable information in any form, whether communicated electronically, on paper, or orally. The rule does not preempt state law that affords more stringent privacy protection; thus, the health care industry will have to comply with multiple layers of federal and state law. The rule affords patients rights to education about privacy safeguards, access to their medical records, and a process for correction of records. It also requires the patient's permission for disclosures of personal information. While privacy is an important value, it may conflict with public responsibilities to use data for social goods. The rule has special provisions for disclosure of health information for research, public health, law enforcement, and commercial marketing. The privacy debate will continue in Congress and within the president's administration. The primary focus will be on the costs and burdens on health care providers, the ability of health care professionals to use and share full medical information when treating patients, the provision of patient care in a timely and efficient manner, and parents' access to information about the health of their children.