Blog from April, 2020

Brandi Vincent


The pandemic-driven outcomes could demonstrate what strategic interagency efforts around emerging technology can catalyze in rapid timeframes.


Three federal agencies have teamed up to collectively leverage and accelerate 3D printing and other advanced manufacturing technologies in the fight against COVID-19.

The Food and Drug Administration, Veterans Affairs Department and National Institutes of Health recently signed a Memorandum of Understanding to formalize a unified effort through which they’ll solicit designs for, produce and test 3D-printed personal protective equipment and other medical supplies to support America’s response to the worldwide health emergency. 

Through the work, the agencies are also engaging in a public-private partnership with the non-profit accelerator America Makes, which will act as a sort of matchmaker between the health care facilities that need the agency-approved, to-be-printed goods and manufacturing industry insiders with the capabilities to produce them. 

“This initiative is rapidly evolving,” Dr. Beth Ripley, chair of the Veteran’s Health Administration's  3D Printing Advisory Committee and enterprise lead of VHA’s 3D Printing Network told Nextgov Monday. She now also serves as VA’s representative for the new MOU-driven effort.

As Ripley’s title suggests, federal agencies have been harnessing 3D printing to serve their missions in a variety of efforts over the last few years. But the global spread of the novel coronavirus ushered in new equipment shortages and growing strains on America’s medical supply chain—and subsequently introduced a fresh use for 3D printing, which can rapidly accelerate the speed between the first concept of a product, and the time it takes to produce it into reality. FDA, NIH and VA already possess the resources necessary to quickly test and share 3D-printed designs of face masks, shields and other supplies that medical personnel now need, so they likely came together to help accelerate that delivery.

Ripley shared details on the process laid out in the memorandum. It begins with NIH’s 3D Print Exchange, which is an existing tool used to share and find models that are clinically relevant and readily compatible with 3D printers. People with 3D designs of materials relevant to COVID-19 that they aim to share can submit them to NIH online. Then VA evaluates and tests the submitted designs. 

“The VA 3D Printing Network prints the parts and assesses their safety and clinical efficacy in collaboration with VA’s frontline medical providers,” Ripley explained.

As part of its duties highlighted in the memorandum, VA, through its Innovation Ecosystem, also swiftly launched an external website that interested individuals and health care entities can access to submit designs, find solutions, or support the testing involved. As the designs prove to be safe and effective in VA’s assessment, FDA then participates in the review process, provides guidance and ultimately makes the final designs easily accessible online. 

Finally, America Makes acts as a streamlined, solitary voice that connects those with significant 3D-printing capabilities to health care facilities with urgent needs for the supplies approved in the agencies’ process.

The partnership came together fast, moving from the original collaboration concept to actual existence in less than a week. And it’s already producing results. 

"In just six days, VA tested two face shields and designed and tested one face mask,” Ripley said. “We have already made significant progress in a short time."



Matthew Michela


Driven by business interests, many healthcare organizations continue to use the pretext of patient privacy all too easily, to keep data locked away. It's time to review what this generation of patients really want.


When I started working in healthcare, I was speaking and writing about the lack of interoperability and its effect on cost and quality. Now, three decades later, despite advances in science and technology, unfortunately, most of the barriers to interoperability are essentially still in place. The financial incentives and business practices preventing interoperability are so entrenched that it’s taken a perfect confluence of forces to make cracks into heavily fortified data silos. Finally, market forces combining the entry of new big tech companies, a meteoric rise of consumerism in healthcare, and regulatory vigor are setting the foundation for change.

New Regulations Pave the Way
The Federal Health IT Strategic Plan released by the Office of the National Coordinator (ONC) is a broad plan that seeks to address these structural problems. First, we’d like to applaud the ONC for its extremely well thought out and comprehensive plan. It succinctly captures the wide range of challenges and the major components that need to be addressed in order to break down those barriers.  The plan also provides a clear structure and guidance on these issues.

The plan, however, would benefit from a measure of prioritization of the objectives and strategies, or guidance on which should receive more emphasis in the immediate future. Among the 13 objectives identified in the plan, several would generate a more immediate impact and would accelerate progress and momentum of the other objectives if they received more immediate attention.

Patient Ownership of Data Controls Everything Else
The plan specifically calls out, and correctly so, the paramount importance of patients’ right to control their health, and how this must include the right to access and control their health information.

For decades, national policy on healthcare data privacy has been based upon the determination that healthcare data is especially sensitive, vitally important, directly impactful, and needs to be more secure than even our financial data. As such, it has been protected, held highly confidential and locked away as a fundamental condition of its collection. The protection of patient data has worked its way into every aspect of healthcare from the design of all technology, research, direct patient care, and even the design of physical facilities.

While the goal of keeping patient data confidential has been largely achieved, an unintended consequence of this protective effort has led to a lack of medical data availability — contributing to misdiagnoses, medical errors, suboptimal outcomes, and even patient death. A Johns Hopkins Study estimated that more than 250,000 people die each year due to medical errors, which is the third leading cause of death. Tragically, many of these deaths are preventable and the lack of relevant clinical data at the point of care is universally recognized by clinicians as a major reason medical errors occur.

The Challenge of Democratizing Data
Driven by business interests, many healthcare organizations continue to use the pretext of patient privacy all too easily, conveniently, and frequently to keep data locked away in order to preserve their own financial self-interest and market share.

Meanwhile, over the past 20 years, other industries from banking to navigation apps have allowed consumers to make their own choices about how private they want their data to be, in return for other tradeoffs in their lives. This generation of citizens openly shares its physical location with third parties to more conveniently navigate the roads and avoid delay. Consumers share their biometrics with fitness companies so they can be guided more effectively in exercise. They share their purchases and spending habits so they can more efficiently search for the product that best fits their need. They share videos of their home interiors and exteriors so they can watch their pets during the day or ensure the safety of delivered packages. They share their banking and financial information so they can improve their credit scores. And so on…

ONC has the capability to emphasize this point in both its policy-making and its ability to influence industry dialogue and perceptions. It’s critical to revisit our cultural perspective on the importance of the government, in combination with physicians and big industry, as the entities determining the rules for healthcare data privacy for citizens. This is an important step in helping clear the road for achievement of the ONC’s heath IT goals. As an example, even getting to a single national identifier would allow the ONC to better establish standards and procedures to share data and dramatically accelerate the achievement of the identified objectives. Subsequently, technology companies of all sizes can make decisions on where to invest development dollars.

This generation of citizens has demonstrated their capability, interest, and capacity to understand complex issues and make decisions for their own lives. It’s time to get them engaged on this topic. We may just find that historical assumptions that are generating so much complexity are no longer valid.




Jessica Kent


Organizations are using real-world data to gather evidence on utilization, population health, and the impact of interventions during COVID-19.

As the COVID-19 pandemic continues to disrupt the status quo, the healthcare industry is turning to real-world data to better understand, monitor, and prepare for whatever the virus may bring.

From patient surveys and EHR information, to studies on past outbreaks and hospital capacity, leaders are harnessing the power of real-world data to observe patterns and make critical decisions.

Defined by the FDA as information derived from sources other than traditional clinical trials, real-world data can provide valuable insights into patient health status or care delivery.

With big data playing a major role in the COVID-19 pandemic, this kind of information will prove extremely valuable in the fight against the outbreak.

What real-world data are organizations collecting to better understand COVID-19, and how is the industry using this information to combat the virus?

EXAMINING UTILIZATION RATES, HOSPITAL CAPACITY

The rapid spread of coronavirus has left many hospitals facing unprecedented strains on resources, with limited capacity to care for critically ill patients.

To help researchers, healthcare leaders, and the public identify places with low capacity, some organizations are monitoring data on hospitals’ utilization and capacity rates.

Definitive Healthcare recently partnered with Esri to launch an interactive data platform that allows users to track US hospital bed capacity, as well as potential geographic areas of risk. The resource displays the location and number of licensed beds, staffed beds, ICU beds, and total bed utilization rates across the country.

Some institutions have also leveraged real-world data to design modeling tools that can help hospitals and health systems plan for critical care surges. A team from Penn Medicine developed a tool that would predict surges in clinical demand, as well as best- and worst-case scenarios of COVID-19-induced strain on hospital capacity.

Researchers used publicly available epidemiological data on COVID-19 and clinical outcomes data from multiple Penn hospitals to build the model.

“With close collaboration between the clinical and operational leaders of our health system and data science team, we were able to rapidly explore a range of scenarios based on published data from other regions of the world,” Penn researchers said.

RAND Corporation, a nonprofit research institution, recently created a similar model. Researchers developed an interactive tool that allows decisionmakers to estimate current care capacity and explore strategies for increasing it.

As part of the project, the group reviewed literature on past outbreaks and COVID-19 experiences, conducted surveys of frontline clinicians, and held virtual roundtables with emergency care providers.

“These critical care capacity estimates can inform cross-regional critical care resource sharing—from regions with less demand to those with more demand,” the RAND research team said.

“We encourage hospital leaders and regional and state officials to use this tool to examine critical care capacity creation strategies using assumptions based on data from their communities.”

IDENTIFYING HIGH-RISK PATIENT POPULATIONS

Healthcare leaders and investigators are also gathering and analyzing real-world data to determine who is most at risk during the COVID-19 pandemic.

At Medical Home Network (MHN), a Medicaid accountable care organization, care managers are identifying vulnerable individuals by finding out which patients are experiencing social isolation. MHN asks patients if they live alone, if they are homeless, and whether they have people who will help them if they get sick.

Additionally, the organization is leveraging AI and machine learning to identify which patients have a high risk of admission for COVID-19, or for unrelated complications from respiratory issues.

“After we cross those two lists of patients – those patients who are at risk for being admitted for respiratory failure or COVID-19, and those patients who are socially isolated – we know who to reach out to first,” Art Jones, MD, chief medical officer of MHN, told HealthITAnalytics.com.

Other institutions are collecting patient data to better understand COVID-19 risk factors. Researchers on the Healthy Nevada Project, a population health study combining genetic, clinical, and environmental data, is now incorporating COVID-19 data from consented participants.

In a 13-question online survey, study participants offered information about possible exposure or risks of COVID-19, including recent travel, attendance at large public events, and whether they are experiencing symptoms of the virus.

“The data that our participants have provided us, in less than a week, has allowed us to discover risk factors within communities and take action to live longer, healthier lives,” said Joseph Grzymski, PhD, an associate research professor at the Desert Research Institute (DRI), Chief Science Officer for Renown Health, and principal investigator of the Healthy Nevada Project.

State-level organizations are also utilizing real-world data to demonstrate the impact of COVID-19 on certain communities. The Illinois Department of Public Health (IDPH) is releasing COVID-19 cases by zip code, allowing people to see how the virus is affecting different areas of the state.

The information can help leaders recognize which geographic locations may need stricter interventions or more critical care resources.

TRACKING INTERVENTION SUCCESS, INFORMING NEXT STEPS

As the number of confirmed COVID-19 cases continues to climb, states across the country are adopting stringent intervention methods to curb the spread. Social distancing measures have become commonplace in US communities, and researchers have started to examine the potential impact of these approaches.

At the University of Texas Health Science Center at Houston (UTHealth), a group used an AI tool to discover that stricter, immediate interventions are needed to reduce the spread of coronavirus in the greater Houston area.

The researchers developed the model based on COVID-19 cases in China and Italy, and applied that model to 150 countries around the world. When the virus spread to the US, researchers first used the model at the state level and then the major metropolitan areas in Texas, including Houston.

“Although there are a lot of numbers and a lot of details, we saw two consistent patterns: earlier intervention was better, and more stringent intervention was better than less stringent,” said Eric Boerwinkle, PhD, dean and M. David Low Chair in Public Health at UTHealth School of Public Health.

Stanford University researchers took a broader approach. Investigators developed a data-driven tool that evaluates the possible outcomes of interventions like social distancing and quarantine. Rather than trying to map the exact dynamics of a particular location, the model shows possible trajectories under different hypothetical scenarios.

“We wanted to start a larger conversation about how our long-term response might look,” said Erin Mordecai, Stanford biologist. “We’re concerned about the potential for the disease to rapidly spread once we lift control measures.”

The modeling framework allows for different types, intensities, and durations of interventions to be implemented, and shows how these interventions impact the spread of the virus over time.

“In the future, we are considering additional interventions and scenarios including contact tracing with efficacy dependent on the testing capacity, fatality and hospitalization rates dependent on the age structure of a population, and fatality rates further dependent on hospital capacities,” Stanford researchers said.

As the COVID-19 situation continues to unfold, real-world data will increasingly help healthcare leaders make critical decisions to mitigate the impact of the virus. Tracking, controlling, and understanding coronavirus will largely depend on the industry’s ability to learn from past and current real-world information.



Brandi Vincent


The pandemic-driven outcomes could demonstrate what strategic interagency efforts around emerging technology can catalyze in rapid timeframes.


Three federal agencies have teamed up to collectively leverage and accelerate 3D printing and other advanced manufacturing technologies in the fight against COVID-19.

The Food and Drug Administration, Veterans Affairs Department and National Institutes of Health recently signed a Memorandum of Understanding to formalize a unified effort through which they’ll solicit designs for, produce and test 3D-printed personal protective equipment and other medical supplies to support America’s response to the worldwide health emergency. 

Through the work, the agencies are also engaging in a public-private partnership with the non-profit accelerator America Makes, which will act as a sort of matchmaker between the health care facilities that need the agency-approved, to-be-printed goods and manufacturing industry insiders with the capabilities to produce them. 

“This initiative is rapidly evolving,” Dr. Beth Ripley, chair of the Veteran’s Health Administration's  3D Printing Advisory Committee and enterprise lead of VHA’s 3D Printing Network told Nextgov Monday. She now also serves as VA’s representative for the new MOU-driven effort.

As Ripley’s title suggests, federal agencies have been harnessing 3D printing to serve their missions in a variety of efforts over the last few years. But the global spread of the novel coronavirus ushered in new equipment shortages and growing strains on America’s medical supply chain—and subsequently introduced a fresh use for 3D printing, which can rapidly accelerate the speed between the first concept of a product, and the time it takes to produce it into reality. FDA, NIH and VA already possess the resources necessary to quickly test and share 3D-printed designs of face masks, shields and other supplies that medical personnel now need, so they likely came together to help accelerate that delivery.

Ripley shared details on the process laid out in the memorandum. It begins with NIH’s 3D Print Exchange, which is an existing tool used to share and find models that are clinically relevant and readily compatible with 3D printers. People with 3D designs of materials relevant to COVID-19 that they aim to share can submit them to NIH online. Then VA evaluates and tests the submitted designs. 

“The VA 3D Printing Network prints the parts and assesses their safety and clinical efficacy in collaboration with VA’s frontline medical providers,” Ripley explained.

As part of its duties highlighted in the memorandum, VA, through its Innovation Ecosystem, also swiftly launched an external website that interested individuals and health care entities can access to submit designs, find solutions, or support the testing involved. As the designs prove to be safe and effective in VA’s assessment, FDA then participates in the review process, provides guidance and ultimately makes the final designs easily accessible online. 

Finally, America Makes acts as a streamlined, solitary voice that connects those with significant 3D-printing capabilities to health care facilities with urgent needs for the supplies approved in the agencies’ process.

The partnership came together fast, moving from the original collaboration concept to actual existence in less than a week. And it’s already producing results. 

"In just six days, VA tested two face shields and designed and tested one face mask,” Ripley said. “We have already made significant progress in a short time."