Loyola University Chicago School of Law, JD 2022
President Joe Biden has issued a number of Executive Orders, many of which address the ongoing COVID-19 public health emergency. On January 21, 2021, President Biden released another pillar of his Administration’s long-term plan to direct the United States out of the throes of the pandemic. The twelfth Executive Order titled, “Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats” orders the Department of Health and Human Services (“HHS”) Secretary Alex Azar to conduct a nationwide review of the interoperability of public health data systems in an effort to enhance the collection, sharing, analysis, and collaboration of de-identified patient data.
Why is data gathering and sharing a priority?
The Biden Administration has emphasized its dedication to prioritize and improve federal data collection and distribution as it relates to COVID-19 metrics. In order to restore trust in public health institutions during this year-long pandemic, there must be equitable supports, responses, and patient outcomes across the country. President Biden has organized his 198-page pandemic response plan around seven main goals and each pilar relies on increased data-sharing at its core. Federal, state, local, and Tribal governments develop their public health policies based on data insights and community need, but the infrastructure they rely on for the collection and synthesis of this data is severely lacking.
Despite the abundance of metrics available to policymakers and health care leaders, the lag in processing the data is often one to three weeks behind and render the data relatively useless in hindsight. As a result, many public health policies have proven to be more reactive to the spread of the virus rather than proactive solutions to curb the infection rates. For example, Dr. Anthony Fauci has stated that the levels of undetected community spread via asymptomatic carriers are still relatively unknown and will continue to be without a comprehensive data collection policy. Until public health officials can obtain better information on testing, positive cases, deaths as a result of the virus, and vaccinations at the local, state, and federal levels, COVID-19 will persist and its mutations will continue to infect communities.
How will the new Executive Order be implemented?
President Biden’s executive order calls on the leaders of multiple federal agencies to promote the collective and publication of COVID-19-related data with a designated pandemic response coordinator who will synthesize and relay this information to the appropriate local, Tribal, state, and other federal entities. The pandemic response coordinator will also assist with the development of policies for the specific locality based on their insights and interpretation of the data. The Office of Management and Budget will be diverting funds for the hiring of more technical staff in all federal agencies dealing with pandemic data in order to promote efficient strategies in data collection systems and processes.
In addition to the new multi-level coordination efforts, the Centers for Disease Control and Prevention (“CDC”) has been mandated to design a new dashboard for reporting of county-level COVID-19 cases in an effort to allow data submission from multiple levels and community leaders. The CDC has unique access to information submitted by commercial, public health, and in-house hospital laboratories and this information is expected to be included in the dashboard. The current COVID-19 patient data reporting system is managed by HHS. President Biden will appoint a Response Coordinator specifically to monitor HHS’ data system interoperability capabilities and effectiveness with detecting public health threats before they happen.
Although the White House has yet to respond to questions about what it envisions for the funding of public health data collection systems in local, Tribal, and state governments; the Executive Order calls for funding and innovation beyond the federal level. Additional guidance is also expected on the requirements to de-identify specific patient information as it related to the compliance with the Health Insurance Portability and Accountability Act (“HIPAA”), a federal privacy law that outlines rules for sharing personal health information.
What are the barriers to President Biden’s data-driven pandemic response plan?
Providers, community health leaders, and local government leaders have been inundated with data reporting requirements from the CARES Act, the CDC, HHS, and the Trump Administration throughout the course of the pandemic. Hospitals reported massive confusion and chaos with drastic shifts in COVID-19 patient data requirements throughout 2020. During the summer of 2020, providers were directed to report to their state, the CDC, and HHS, until HHS Secretary Azar directed all providers to skip the CDC and report only to HHS. Although there have been widespread inaccuracies in reporting metrics, most providers have demonstrated an adjustment to the new system. Another shift in data reporting requirements from the Biden Administration could yet again cause confusion and prolonged delays in information processing and analysis of COVID-19 patient data.
Another complicating element for President Biden’s data collection plan is the lack of a national health records system among providers and also public health authorities. The data that is sent into the CDC, HHS, and other agencies is received in varying formats and often lacking in unified qualitative and quantitative measures, and controls. The Biden Administration will need to release a detailed plan with the expectations for data-reporting if meaningful analysis is to be conducted on the demographic data that identifies specific communities hit hardest by the pandemic. This data is essential to the federal support of Personal Protective Equipment (“PPE”) distribution, testing supports, and the distribution of vaccinations.
Health care providers, public health officials, and government leaders across all levels will be impacted by President Biden’s Executive Order in the coming weeks and months. Although the plan is new, the health care industry will need to pay special attention to the White House for updates on the data initiative in order to remain in compliance with federal laws particularly providers participating in the Medicare and Medicaid programs.