Preparing for the Next Public Health Emergency Response Letter

HIMSS and the Personal Connected Health Alliance (PCHAlliance) provided feedback to the U.S. Senate Committee on Health, Education, Labor and Pensions white paper, Preparing for the Next Pandemic, in an effort to better position our nation to address COVID-19 and prepare for future actions.

Disease Surveillance—Expand Ability to Detect, Identify, Model and Track Emerging Infectious Diseases

Recommendation: Timely Data to Illustrate Population Disparities

In response to Issue and Recommendation 2.1, “Timely Data to illustrate population disparities,” we concur that timely population level data is essential to identify and then address health disparities. It is also important to support and fund data visualization capabilities. We commend the Centers for Medicare and Medicaid Services (CMS) for recently releasing population level COVID-19 data on Medicare beneficiaries. These data are essential to spark the development of appropriate interventions.

Public Health Capabilities—Improve State and Local Capacity to Respond

HIMSS and PCHAlliance fully support the goals included under Issue 4. We believe it will be critical to develop and implement the necessary strategies, tools, and mechanisms now to ensure we minimize any disruption to our healthcare system during future pandemics. To that end, we offer the following recommendations and points of consideration to the Committee:

• To best leverage our experiences during the COVID-19 pandemic and come out better prepared for future pandemics, we must embed greater resiliency in our healthcare system, particularly through the use of connected care (e.g., telehealth, remote patient monitoring). In response to the urgent needs and challenges presented by COVID-19, and with the goal of decreasing the risk of transmission for healthcare workers and their patients, our whole country transitioned to digital health seemingly overnight. Regulatory changes across all levels of government unleashed an unprecedented wave of telehealth and connected care adoption. This provided a lifeline for healthcare providers and patients to use digital health solutions to support care delivery and help the most vulnerable populations avoid unnecessary exposure.

U.S. healthcare providers have made significant investment in technology, workflow, and training to stand-up and provide the full range of evidence-based connected care services. For many, particularly smaller practices, this required capital investment was in addition to new policies, procedures and training.

The waivers and temporary healthcare standards and policies that were adopted in response to our nation’s COVID-19 emergency must either be made permanent on a case-by-case basis, or at a minimum will require a time- or metric-defined transition period, rather than a sudden termination. This would reassure patients and providers that the care they are currently receiving will not be disrupted and provide clarity to healthcare providers that the investments made during the pandemic can be leveraged moving forward. Additionally, for those waivers and flexibilities that are not made permanent, we must ensure that they will be exercised and leveraged during future pandemics. This will provide consistency and clarity to patients and providers and will help connected care become part of “routine” healthcare delivery, particularly during future pandemics.

• Additionally, it is far easier to scale up existing mechanisms during a crisis than it is to implement new ones. During future pandemics, we support efforts to encourage or otherwise incent industry and market suppliers to provide flexible licensing policies to allow for the necessary scaling and contraction of systems to support healthcare delivery during a pandemic. As mentioned above, we also urge any regulatory waivers to ramp up and ramp down slowly enough to give industry time to adapt or provide alternative sources of funding to offset unexpected costs.
• To ensure that patients continue to receive the necessary healthcare they require irrespective of a pandemic, HIMSS and PCHAlliance believe that specific clinical care and workflow strategies for various specialties and cohorts of people (e.g., pediatricians) should be developed and implemented. This would help guarantee that individuals are receiving the minimum necessary care (e.g., receiving vaccinations at the appropriate time) throughout a pandemic.
• Key stakeholders across the healthcare ecosystem, including health information exchanges (HIEs), hospital systems, federally qualified health centers (FQHCs), technologists, and educational institutions, should increase involvement in the planning and development of multi-year emergency preparedness plans, state health IT roadmaps, and other strategic plans with a concurrence process based on the principles of clarity, equity, transparency and collaboration among stakeholders.
• Leverage existing interoperability standards and profiling work.
  • HIMSS is partnering with HL7 International and Integrating the Healthcare Enterprise (IHE) International to accelerate the deployment of application programming interfaces (APIs), such as Fast Healthcare Interoperability Resources (FHIR®), through the creation of the Global Consortium for eHealth Interoperability. The Consortium is going to engage in and convey real world testing guidance such as test plan development, share their roadmaps and interoperability vision for global community benefit, and develop online resources to share best practices, use cases as well as interoperability strategy planning.
  • In addition, IHE is creating and maintaining implementation guidelines, called IHE Profiles, which provide a common language for purchasers and developers to discuss the integration needs of healthcare entities and the integration capabilities of health IT products.

• In addition to establishing standardized ways to format and structure data to represent its meaning in unambiguous computable ways, integrated transport and security mechanisms are critical to enable healthcare providers to reliably send, receive, find and use patient data when and where it is needed.

State public health agencies often lack adequate funding to ensure their information systems are updated and conform to national interoperability standards. We encourage support for state registries that manage and track information for immunizations, infectious diseases, and vital statistics to adopt existing standards and profiles, such as those developed by IHE Quality Research and Public Health Domain (QRPH), and fund state agency participation in industry interoperability testing events, including the IHE North American Connectathon.

• The U.S. Department of Veterans Affairs’ (VA) “fourth mission” is to “improve the Nation’s preparedness for response to war, terrorism, national emergencies, and natural disasters by developing plans and taking actions to ensure continued service to veterans, as well as to support national, state, and local emergency management, public health, safety and homeland security efforts.” In March 2020, VA was looking for IT professionals and clinicians to help staff pop-up testing sites. Some stakeholders were not aware VA would be able to provide these types of staff supports and services, which complicated the process. It is critical for all stakeholders to improve their awareness of this mission prior to the next pandemic to ensure a continuity of the healthcare system. Local, regional, and national preparation and training exercises should include VA professionals in the planning and execution phases, so communities are not relearning the VA’s role and mandate in the midst of the pandemic. HIMSS and PCHAlliance are committed to continue to partner with VA on this initiative.

Recommendation—Ensure that the United States Does Not Lose the Gains Made in Telehealth

We have long envisioned a healthcare system that seamlessly incorporates the use of connected care to enable improved quality, measurable outcomes, and increased access to healthcare for consumers while reducing complexity and costs. As noted above, the decisive actions taken by Congress and CMS in response to COVID-19 removed certain 1834(m) restrictions on telehealth and other regulatory barriers on connected care. This ensured the safe, timely and effective treatment of patients under quarantine, while simultaneously limiting further disruption in access to care, diagnosis and treatment. We fully acknowledge that the purpose of these regulatory flexibilities was to address the unique needs brought by COVID-19, on a temporary basis. However, the rate at which patients and providers rapidly and decisively adopted telehealth as a key tool in supporting, augmenting, and in many cases substituting for in-person care indicates not only a willingness, but a desire to embrace these tools on a permanent basis.

Now is the time to work towards creating a comprehensive policy framework that is predictable, forward-looking, and encourages innovative and novel approaches to care delivery. In addition to reimagining and rewriting the policies that once held back technology and discouraged innovation, we must capitalize on many of these temporary flexibilities and make their adoption permanent.

While the gains made in telehealth have had a profound impact on healthcare access and delivery in the US, many communities have been left behind. The digital divide has resulted in a lack of reliable and affordable broadband and has continued to prevent many patients and providers from utilizing telehealth and other connected care technologies. We must continue to address these disparities by making crucial investments in broadband deployment, specifically targeting underserved and rural areas, including anchor institutions and tribal lands. Research shows this lack of access negatively impacts the health of communities and clinicians’ ability to provide necessary care. Reliable and affordable broadband is critical to realize the full potential of telehealth and other connected care technologies and improve access to high quality care for all Americans.

Additionally, one of the many temporary changes in response to COVID-19 that helped expand access to telehealth was the issuance of licensing waivers, at both the state and federal levels, to support the practice and provision of care across state borders. While many of these waivers were temporary and limited to the COVID-19 pandemic, we support future efforts that ensure healthcare providers can practice safely at the top of their license across state lines without any significant undue burden. Such action can help address workforce shortages, increase access to specialty care, and further remove barriers to the adoption of connected care. We believe technology can help support credentialing changes.

Recommendation—States Need to Maintain the Capacity to Trace Contacts for Emerging Infectious Diseases, and Have Programs in Place to Surge that Capacity if Necessary

Governmental health agencies at all levels should immediately consider the engagement and deployment of mobile or digital contact tracing apps that can help expedite outbreak management and response, including hot-spotting, that also support re-opening of business, and that support the development of vital information at the community level, including:

• Daily number of cases
• Number of contacts identified through contact tracing
• Data to determine how quickly patients are isolated; if and when contacts are notified and advised to quarantine and self-monitor
• Data to inform human services and social support systems to assist the most at-risk communities
• Data to inform and support data analytics for informed policymaking at all levels of government

The use of mobile contact tracing apps along with aggressive testing will further enhance health authorities’ ability to limit perpetual outbreaks. Leveraging mobile or internet-based applications can greatly improve infection control activities within an optimal 48-72 hour timeline, thus hastening the ability of health authorities to quickly manage hotspots. Moreover, health authorities need to encourage and maintain standardized data inputs (including demographics and the aforementioned data points) to ensure robust interoperability and reporting capabilities across county, state, and country boundaries.

Responses to White Paper Questions

Disease Surveillance—Expand Ability to Detect, Identify, Model, and Track Emerging Infectious Diseases

What other barriers, in addition to limited testing capacity, and insufficient and outdated technology, make it difficult to detect and conduct public health surveillance of emerging infectious diseases?

HIMSS and PCHAlliance strongly urge prioritization of necessary funding and technical assistance to implement modern health information and technology strategies to ensure timely interoperability and sharing of public health surveillance data. An important component is the work of HIMSS, along with the Association of Public Health Laboratories (APHL), Council of State and Territorial Epidemiologists (CSTE) and the National Association for Public Health Statistics and Information Systems (NAPHSIS) that support the Data: Elemental to Health Campaign, a multi-year effort to modernize public health data systems, surveillance, and analytics at the Centers for Disease Control and Prevention (CDC) and state, local and tribal health departments. HIMSS and its partners welcome the funding included in the Fiscal Year 2020 Appropriations Package and the Coronavirus Aid, Relief and Economic Security (CARES) Act, but funding addresses only some of the challenges in this area. Overall, in the long-term, we need a predictable and sustained funding source to fully tackle this issue.

We recommend that the Committee also highlight and bolster the work underway at CDC on its Data and IT Modernization Strategy, which equips states, territories and local governmental public health agencies with the ability to capture and assess complete data points and information necessary to address 21st Century public health concerns, including COVID-19. CDC’s plan builds on expanding core data, informatics and IT capacity; advancing interoperable systems and tools; and the growing public health’s data science, informatics and IT savvy workforce. Specifically, the plan helps to promote the ability to capture and quickly assess real-time data from national disease surveillance systems, most notably the National Notifiable Diseases Surveillance System and National Vital Statistics System, as well as related syndromic surveillance and electronic laboratory reporting systems. Overall, this work will have a significant impact on the ability of our health surveillance system to mitigate how emerging infectious diseases affect populations.

In addition, broader interoperability efforts and the increased use of standards in public health reporting would also be helpful tools in ensuring timely communication among public and private health system stakeholders. According to the Office of the National Coordinator for Health IT (ONC), healthcare organizations can reduce implementation costs, accelerate integration projects, and take advantage of common collaborative endeavors by using standards whenever possible. Several projects underway at ONC push the community in the direction of greater use of the following common standards:

• The Interoperability Standards Advisory increases public awareness of interoperability standards and implementation specifications that can be used to address specific interoperability needs, including for public health purposes
• The Interoperability Proving Ground is an open, community platform where entities can share, learn and be inspired by interoperability projects occurring in the United States and globally

With more resources directed to ONC, these efforts could have an even greater impact on increasing nationwide interoperability as well as the broader use of health IT standards that help address public health needs.

Moreover, a major advance in the health IT standards domain has been the introduction of the FHIR standard from HL7® that simplifies interoperability processes. The Global Consortium for eHealth Interoperability is capitalizing on the expanded use of the FHIR standard.

There are also several existing national interoperability/health information exchange frameworks and networks (e.g., eHealth Exchange, Carequality, CommonWell, and state and regional efforts) that should be leveraged to ensure there is robust and standardized data exchange between and among public health entities and state and local health departments.

What appropriate role can innovative technologies play to improve public health surveillance?

We envision that innovative technologies, as well as novel uses of existing technologies, will continue to play a major role in improving surveillance. COVID-19 has driven innovation in our health system on a constant basis to address the multitude of challenges that have accompanied the onset and spread of the virus. Innovation thrives when the environment is structured appropriately and we envision that COVID-19 will continue to offer the community opportunities to innovate on surveillance-related issues.

The Committee should also look at opportunities for innovation in incentivizing public-private partnerships in states and large population centers that use smart health technologies such as artificial intelligence and machine learning. These technologies can provide predictive analytics with hourly detection capabilities as well as continuous monitoring for potential outbreaks, leading to greater situational awareness and timelier interventions.

The use of innovative technologies at all levels of government and healthcare delivery will also improve the ability to track trends and plan interventions. For example, Washington state is collaborating with Microsoft’s Data Science Team to build an efficient system that allows data collection about hospitalizations and disease incidence as well as a hospital data collection initiative in the Puget Sound region that captured information about bed, intensive care unit and ventilator capacity, as well as personnel availability. Such a public-private partnership provides a learning laboratory that the Committee should create opportunities for other states to model and emulate.

CDC is also directly engaged in innovative public-private partnerships that improve public health surveillance. Along with CSTE and APHL, CDC is implementing shared electronic case reporting (eCR) services to provide electronic case reports to public health agencies for integration into their surveillance systems.

The eCR Now App is constructed to connect to, and take advantage of, existing infrastructure, and is built to leverage the work the Argonaut Project, HL7, and ONC that have advanced the FHIR APIs that are now implemented in electronic health records (EHRs). For a case study, OCHIN went live with the eCR Now App across 19 states to report COVID-19 cases electronically on April 17, 2020. Thus far, OCHIN has submitted nearly 59,000 case reports to CDC related to COVID-19. This data helps explain the importance of CDC’s work generally and reinforces its partnership functions.

Additional innovative eCR efforts should be under consideration as the Committee contemplates innovative areas for future investment in public health surveillance.

There is a genuine long-term investment opportunity for CDC to implement public-private partnerships in this area to more broadly implement eCR, and fund states to improve their disease surveillance systems as well as improve laboratory reporting.

In terms of how we can facilitate innovative use of technologies, we would highlight our work underway on developing a Digital Health Indicator (DHI) measurement tool to inform health system strategy to advance digital health transformation. The DHI measures progress toward a digital health ecosystem—one that connects clinicians and provider teams with people, enabling them to manage their health and wellness using digital tools in a secure and private environment whenever and wherever care is needed. Operational and care delivery processes are outcomes-driven, informed by data and real-world evidence to achieve exceptional quality, safety and performance that is sustainable. DHI guides health system and leaders by measuring progress towards digital health systems, as well as transformation of digital care delivery that is focused on outcomes, and informed by data as well as real-world evidence.

What privacy protections should accompany new technology? Would these technologies be utilized and maintained by HIPAA-covered entities or others?

HIMSS and PCHAlliance encourage the Committee to ensure that new COVID-19-related technologies are accompanied by privacy protections that go beyond what is offered by HIPAA-covered entities. We want to synchronize and balance HIPAA privacy practices with the needs of our current electronic landscape as well as the demands placed on the healthcare community by other laws and measures. Some of the considerations that need to be taken into account include:

• HIPAA alignment with other laws and regulations is a key consideration when thinking about implementation. The patchwork of existing state laws focused on health information privacy make for a challenging environment when attempting to share data. Most of these state laws are not preempted by HIPAA, so inter- as well as intra-jurisdictional information sharing is impacted by myriad regulations and uncertainty over what rules apply in particular circumstances. This has the potential to lead to hyper-interpretation as a means to achieve compliance as opposed to supporting the efficient sharing of key health information to advance high quality, valued-based care related to COVID-19.
• HHS published a report in June 2016 titled, Examining Oversight of the Privacy & Security of Health Data Collected by Entities Not Regulated by HIPAA. It identified how large gaps in policies around access, security, and privacy continue, and confusion persists among both consumers and innovators. With new health-related technologies such as wearable fitness trackers, health social media, and mobile health apps gaining prominence in engaging patients, the report details how our laws and regulations have not kept pace with these new technologies. The HHS Report also identifies the lack of clear guidance around consumer access to, and privacy and security of, health information collected, shared, and used by those entities not covered by HIPAA.

Given the current environment, and the blending of information between HIPAA-covered entities and non-covered healthcare providers, any privacy protections will need to be more extensive than simply focusing on HIPAA-covered entities. As Congress and the Administration consider broader health data privacy changes, these issues need to be addressed, especially as COVID-19 persists. Patient privacy needs must be prioritized moving forward, and ensuring that they have granted consent and maintain control over their information as well as who their information is shared with is vitally important. Any location data and all other personally identifiable information should be appropriately safeguarded, and any device that stores data should have strong encryption management practices. In addition, such data should only be kept as long as necessary pursuant to a data retention policy (e.g., seven days, or 14 days, or 30 days, etc.) and securely deleted thereafter. Under any scenario, the key principles are that the patient is involved, engaged, and at the center of any decision-making involving the sharing of their personal data.

Stockpiles, Distribution, and Surges—Rebuild and Maintain State and Federal Stockpiles and Improve Medical Supply Surge Capacity and Distribution

How can states and hospitals improve their ability to maintain a reserve of supplies in the future to ensure the Strategic National Stockpile is the backup and not the first source of supplies during emergencies?

We point to the HIMSS Clinically Integrated Supply Outcomes Model (CISOM) as a data-linkage tool to provide organizations with a strategic pathway to track processes and products used in care, by mobilizing data to create real-world evidence of impact and outcomes for patient populations. Health systems use CISOM to create an automated supply chain infrastructure at the point of care in their organization to proactively identify risk of adverse events and cue clinicians to risk. Our work enables proactive interventions to prevent adverse events, which in turn, strengthens quality and safety for patients and improves system performance. The model guides organizations to adopt and implement four key focus areas to achieve a clinically integrated data infrastructure in clinical settings: 1) Automation; 2) Clinical Integration; 3) Predictive Data Analytics; and 4) Governance and Leadership.

In addition, we request that the committee consider the application of blockchain in healthcare to support supply chain management, which is a common use case. In addition, the Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) (2013) includes a 10-year rollout to address secure track and trace needs for drug companies. Many blockchain-enabled solutions are growing to address the needs outlined in this legislation. DSCSA supports a pilot program to explore innovative solutions to ensure compliance with the forthcoming DSCSA requirements; solutions include blockchain, artificial intelligence and APIs.

Public Health Capabilities—Improve State and Local Capacity to Respond

What specific changes to our public health infrastructure (hospitals, health departments, laboratories, etc.) are needed at the federal, state and local levels?

HIMSS and PCHAlliance encourage the Committee to consider the following changes to our public health infrastructure at the federal, state and local levels:

• As described above, HIMSS is partnering with HL7 International and IHE International on the Global Consortium for eHealth Interoperability, which could support and advance a worldwide interoperability use case around sharing infectious disease outbreak information so national health agencies would be better prepared to respond to future pandemics.
• Build consensus among federally funded efforts that often may overwhelm public health and healthcare providers who are inundated with spending time sharing similar information to different entities. Leverage national associations, including HIMSS to convene and organize stakeholders.

In addition, each year, 2–3 million lives are saved globally by vaccinations. Research shows that being up-to-date on vaccinations leads to better health outcomes, higher levels of productivity and lower healthcare costs. Sharing of data between EHRs, immunization information systems (IISs) and state immunization registries play a key role in helping clinicians manage and administer vaccines and improve public health. In order to effectively track and distribute any vaccine, it will be important to leverage and, as appropriate, provide additional support to existing public-private partnerships to help improve nationwide public health information exchange in support of a pandemic response.

A good case study is the Immunization Integration Program (IIP), implemented by HIMSS, the Drummond Group, and Chickasaw Health Consulting, LLC (CHC) under a contract with the CDC National Center for Immunization and Respiratory Diseases (NCIRD), that convenes clinicians, EHR developers, IISs, public health and other key stakeholders to improve interoperability, information sharing and management. The goal of IIP is to ensure that clinicians and IISs have timely access to complete and accurate data to improve clinical decision-making and management, increase vaccination coverage and reduce vaccine-preventable diseases.

In addition, HIMSS and IHE USA manage the North American Connectathon, the health IT industry’s largest formal interoperability testing event. Each year, nearly a dozen state public health registries participate in interoperability testing with hundreds of representatives from leading health IT market suppliers and system developers. Improving the nationwide response to track and manage immunizations, vital records, infectious diseases and other key information requires stronger engagement by every state to update their systems, implement national standards, test for and validate their interoperability capabilities.

• Ensure funding mechanisms for public health agencies at all levels to adhere to Public Health 3.0 and data modernization efforts, including the expansion of the public health epidemiological and data science workforce. Support the creation of functional roles such as a chief health strategist in all states, territories and cities/population centers to drive reporting and data analytics by leveraging timely, reliable, granular-level, actionable data to guide, focus and assess the impact of disease control and prevention initiatives in their communities. Include a focus on upstream interventions to address public health emergencies, such as COVID-19.
• Incentivize HIEs to enhance the exchange of health information across geographical/public/private data boundaries. This aims to improve data analytics and strengthen capabilities for real-time information on COVID19 through efficient, non-burdensome reporting, and data collection.
• Support health innovation models that demonstrate the value of cross-sector collaboration between health departments, intra-governmental departments, and community entities (e.g., hospitals, clinics and community-based organizations).
• Modernize public health technology infrastructure (See Disease Surveillance, Question 1 on support of the Data: Elemental to Health Campaign, a multi-year effort to modernize public health data systems, surveillance, analytics at the CDC, as well as state, local and tribal health departments).

What changes can be made to Public Health Emergency Preparedness and Hospital Preparedness Program to help states prepare and respond more quickly?

HIMSS and PCHAlliance highlight the importance of funding for the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PL 116-22), with special consideration of Sections 203 and 205. These provisions are focused on implementing practices and protocols for a more regional approach to preparedness and response and include physical and technology infrastructure considerations via state grants.

In addition, we encourage the HHS Assistant Secretary for Preparedness and Response (ASPR), in coordination with CDC, to facilitate changes to our public health communications and surveillance networks by directing HHS to update the adoption of technical and reporting standards, including standards for interoperability (as defined by the 21st Century Cures Act), and facilitate greater coordination and collaboration within the Department and across federal agencies through the exchange of data and other health information.

Who Is on the Flagpole?—Improve Coordination of Federal Agencies During a Public Health Emergency

How can federal departments and agencies more effectively work together to respond to public health emergencies?

ASPR plays a critical role in coordinating a whole-of-government response to COVID-19 and any future pandemics. However, we need to highlight the importance of other agencies and their work in helping to address COVID-19. CDC is integral in any public health response, and the work that it initiates at the state level to improve their disease surveillance systems as well as improve laboratory reporting would need to be prioritized. ONC also has a part to play in promoting health IT standards and greater adherence to those standards in processes around exchanging relevant data. Overall, we see HHS collaborating very closely with the Federal Emergency Management Agency to lead any response to public health emergencies, with ASPR and CDC directing HHS’s work in conjunction with other parts of the Department. Clearly defining how federal agencies should work together, as well as delineating each agency’s roles and responsibilities, should eliminate redundancies and lead to a more effective whole-of-government response.

Overall, we see HHS collaborating very closely with the Federal Emergency Management Agency to lead any response to public health emergencies, with ASPR and CDC directing HHS’s work in conjunction with other parts of the Department. Clearly defining how federal agencies should work together specifically to prepare and respond to a pandemic, as well as delineating each agency’s roles and responsibilities, should eliminate redundancies and lead to a more effective and holistic whole-of-government response.