The U.S. FDA has posted a roster of essential medicines and diagnostics for the COVID-19 pandemic based on the Trump administration’s Aug. 6, 2020, executive order 13944, which is directed to ensuring availability of critical supplies during pandemics, natural disasters and threats of human origin. Among the pharmaceutical agents listed are the active pharmaceutical ingredients for drugs such as Enoxaparin (heparin), amiodarone and levofloxacin. The list for medical devices includes tracheotomy tubes, hemodialyzers, reagents for molecular diagnostics, and a number of items in the category of personal protective equipment. Interested parties can comment on the list at docket number FDA-2020-N-2123.
Members of Congress query NIH’s Collins on RADx program
Three Republican members of the U.S. House of Representatives inked an Oct. 29 letter to NIH Director Francis Collins inquiring into how NIH-funded studies can be used to maximize the use of COVID-19 testing for the pandemic. The authors of the letter, including Rep. Greg Walden (R-Ore.), the ranking member of the House Energy and Commerce Committee, requested that Collins arrange a briefing with GOP staff by Nov. 12, to discuss several points of interest, such as whether any of the studies supported by the NIH Rapid Acceleration of Diagnostics (RADx) is directed toward community screening for asymptomatic patients, and whether a RADx study could be used to modify an FDA-issued emergency use authorization. The letter points to an agreement between the Department of Health and Human Services and the Rockefeller Foundation to stand up a study of the use of rapid antigen point-of-care tests for community screening, and the authors gave voice to an interest in similar efforts.
Imminent malware threat reported
U.S. federal government agencies issued a joint cybersecurity advisory regarding credible information suggestive of an imminent cybercrime threat to U.S. hospitals and other health care providers. The threat is attributed to distribution of TrickBot and BazarLoader malware, leading to ransomware attacks, data theft and possibly disruption of health care services. The report states that a single entity is likely behind both malwares, which are commonly distributed via phishing campaigns.
CDC posts telehealth report
The U.S. Centers for Disease Control and Prevention (CDC) posted an update on trends in the use of telehealth during the COVID-19 pandemic, documenting a 154% increase in telehealth services in the last week of March vs. the same period in 2019. However, the share of these telehealth services that were directly related to COVID-19 infections was only 16.2%, with most of these encounters for adults aged 18-49 years (69% in 2020, up from 66% in 2019). The percentage of telehealth visits for children younger than 5 fell in the early pandemic period to 3.5%, an absolute drop of 0.5% from the same period in 2019. A similar drop was seen in the share of telehealth for aged 5 to 17 years, which dropped from 10% to 8.6%. The CDC said the study is somewhat hampered by the limitations of the dataset, drawn from a sample of four large national telehealth providers, and the telehealth visits attributed to COVID-19 were difficult to distinguish from visits due to other respiratory infectious diseases.
CMS unveils AI competition finalists
The U.S. Centers for Medicare & Medicaid Services announced the seven finalists in the agency’s Artificial Intelligence Health Outcomes Challenge, which drew 300 entries when launched in 2019. The seven finalists will refine algorithms that are designed to predict unplanned hospital visits and skilled nursing facility admissions, as well as adverse events. The grand prize winner will receive $1 million in prize money, while the runner-up will snare $230,000, sums that will be awarded by April 2021. Among the final seven are Closedloop.ai of Austin, Texas, Jefferson Health of Philadelphia, and the University of Virginia Health System of Charlottesville, Va.