New Data Rules Could Empower Patients But Undermine Their Privacy
New York Times
The Trump administration announced broad new rules on Monday that will allow people for the first time to use apps of their choice to retrieve data directly from their health providers. The new rules will for first the time require doctors and medical centers to send a core set of medical data directly to third-party apps after a patient has authorized the information exchange. In addition to lab test results and vital signs, the data will include clinical notes about a patient's surgeries, hospital stays, imaging tests, and pathology results. Don Rucker, MD, the national coordinator for health information technology at HHS, said access to medical data through consumer apps would give people more detailed insights into their health and greater choices over their health care. "We as patients have not gotten really anywhere near the benefits from modern computing that we could or should get," Rucker said. "The ability of smartphones to take the care with you, to be continuous, to be engaging, is going to allow totally different ways of thinking about chronic illness." Some industry observers note giving people access to their medical records may heighten risks to patient privacy, and that without accompanying federal safeguards, the new rules could expose people who share their diagnoses and other intimate medical details via mobile apps to serious data abuses.
Coronavirus Test Kits Aren't Keeping Up With Surging U.S. Demand
Wall Street Journal
States on the front lines of the coronavirus fight are complaining about the availability of test kits, exposing strains in the nation's effort to contain the epidemic. The Centers for Disease Control and Prevention (CDC) is now shipping hundreds of test kits. Some public health labs and private lab companies have also rolled out their own test kits. Large commercial lab companies including LabCorp and Quest Diagnostics are launching coronavirus testing services. That has increased the capacity to test samples to thousands of people a day, but public health experts and government officials say that is not enough, especially after CDC recently broadened the criteria for testing to anyone who shows signs or symptoms, had traveled to a country with an outbreak, or come into contact with a confirmed case. The goal is to get to a point where people with symptoms can be tested quickly, but that has proven to be a big challenge. "We are not at that point now," said Tom Inglesby, director of the Center for Health Security of the Johns Hopkins Bloomberg School of Public Health, said at a briefing Friday on Capitol Hill. "We don't have the bandwidth to do that now." FDA Commissioner Stephen Hahn said Friday that as of Thursday, CDC had shipped out supplies for about 900,000 tests. Testing requires more than one specimen per patient, so the number of people who could be tested with those supplies is fewer.
NY State Labs Get FDA Emergency Use Authorization for SARS-CoV-2 Test
The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to two public health laboratories in New York state to run an assay for detecting the SARS-CoV-2 pathogen, which causes COVID-19 infections. The test was approved according to new emergency diagnostic regulations. On Feb. 29, FDA issued guidance allowing high-complexity commercial, academic, and government labs to develop and use SARS-CoV-2 tests. The guidance requires labs to validate their tests subsequently notify FDA. They may then begin using the test, but must also submit a completed EUA request to FDA within 15 days. The New York test is authorized for emergency use on nasopharyngeal and oropharyngeal swabs and sputum samples collected from people who meet the clinical or epidemiological criteria for testing. These criteria include clinical symptoms of COVID-19, contact with a possible or confirmed COVID-19 case, history of travel to a location where COVID-19 cases were detected, or other epidemiologic links. Testing is limited to the New York State Department of Public Health Wadsworth Center and the Public Health Laboratories of the New York City Department of Health and Mental Hygiene.