By Alexandra Weiss, nonprofit strategy, patient organizations, IQVIA.
The past few years ushered in a historic wave of innovation in the therapeutic development landscape, heightening the demand for high-quality, real-world data that captures insights from across the entire patient journey. Advancements in government regulations and data technologies are dramatically improving access to electronic health information, presenting unique opportunities for patient advocacy organizations to serve as trusted data stewards.
As regulations, technology and vendor offerings continue to evolve, patient data strategies and data technology capabilities will equip patient advocacy organizations with the ability to advance research through the lens of real-world patient-centric data. In harnessing the full value of advanced data registries to collect, analyze and share information, patient advocacy organizations can better engage with patients and their communities. These tools also present an unprecedented opportunity for patient organizations to collaborate with the research and life sciences community to drive research advancements using patient-centered data that places patient needs and priorities front and center.
Navigating Changes in the Clinical Research Landscape
When discussing the value of research-grade data registries, it is critical to first consider the ways in which the clinical research industry has evolved. Landmark regulatory advancements such as the 21st Century Cures Act and draft FDA guidance on real-world evidence have accelerated the ability to access interoperable health data.
The Cures Act empowers patients with ownership of their own health data, which they can share with advocacy organizations. This provides patient advocacy organizations with access to insights for a broader scope of patients, disease experiences and treatment journeys, equipping them to play a more active role in regulatory decision making and the advancement of drug approval.
In addition to regulatory advancements, the technology and vendor ecosystems have vastly expanded. Data exchange standards such as Health Level 7, Fast Healthcare Interoperability Resources and data models such as Observations Medical Outcomes Partnership are simplifying analytic product delivery by enabling growth in the automation of data capture and data processing. There is also a broader range of commercial partnership opportunities available to help expand patient engagement and generate evidence related to care delivery and treatment responses.
Finally, patient centricity is transitioning from a general aspiration to an immediate operational priority. As patients become increasingly involved in the clinical research and care process, patient advocacy organizations are better equipped in their roles as trusted data stewards.
These advancements present new opportunities for patient organizations to build a cohesive data strategy and expand registry capabilities to capture a 360-degree view of patient perspectives while supporting patient centricity, data ownership, privacy and security.
With the right patient data registry, patient advocacy organizations can accomplish the following:
Address research gaps and accelerate clinical developments.
Equip patients with the information they need to advocate for themselves in their care
Improve provider understanding of patient treatment needs.
Help investigators ask more relevant questions throughout the clinical research process.
Cultivate more strategic partnerships with other stakeholders in the biomedical research, medical specialty society and therapeutic development spaces.
Facilitate more effective long-term follow-up initiatives to drive positive care outcomes.
The U.S. Department of Health and Human Services (HHS) announces that five cooperative agreements to health information exchange organizations (HIEs) to help support state and local public health agencies in their efforts to respond to public health emergencies, including disasters and pandemics such as COVID-19.
The HHS Office of the National Coordinator for Health Information Technology (ONC) is administering $2.5 million in funding from the Coronavirus Aid, Relief, and Economic Security Acts (CARES Act) signed by President Trump on March 27, 2020.
The funding will support local health information exchanges (HIEs) under the Strengthening the Technical Advancement and Readiness of Public Health Agencies via Health Information Exchange (STAR HIE) Program.
Each of the five recipients will work to improve HIE services so that public health agencies can better access, share, and use health information during public health emergencies. These efforts will also support communities that are disproportionately impacted by COVID-19.
“Health information exchanges have long served important roles in their states and regions by helping health data flow to treat patients,” said Don Rucker, MD, national coordinator for health information technology. “These STAR HIEs will help public health officials make real-time decisions during emergencies like fires, floods, and now, the COVID-19 pandemic.’
The five HIEs, each awarded two-year cooperative agreements, are:
Georgia Health Information Network, Inc. (GaHIN)
Georgia Health Information Network will support the Georgia Department of Public Health and Georgia Department of Community Health to better access, share, and use electronic health information, especially data from populations underserved and/or disproportionately affected by the COVID-19 pandemic. This will include increasing the reporting to a state-wide COVID-19 registry and expanding public health reporting and data enrichment for providers not connected to GaHIN.
Health Current (Arizona)
Health Current (Arizona) will support the Arizona Department of Health Services by improving the timeliness, accuracy, and completeness of hospital reporting of key COVID-19 healthcare data, including facility hospitalization metrics, personal protective equipment (PPE) inventories, and ventilator inventory and utilization. Health Current will also seek to reduce hospitals and health system burden related to state and federal reporting requirements by using the HIE as a data intermediary.
HealthShare Exchange of Southeastern Pennsylvania (HSX)
HealthShare Exchange will modernize the region’s pandemic response with the use of automated application programming interfaces (APIs), supporting the Philadelphia Department of Public Health and the Pennsylvania Department of Health. HSX will also facilitate public health agency use of the Delaware Valley COVID-19 Registry, and create new clinical data connections based on public health agency priorities.
Kansas Health Information Network, Inc. (KHIN) d/b/a KONZA
The Kansas Health Information Network’s KONZA team will expand the number of providers participating in the HIE, enhance lab data that is already being exchanged and combining it with existing HIE data for public health reporting, and add additional information to its real-time alerting platform for the Kansas Department of Health and Environment.
Texas Health Services Authority
The Texas Health Services Authority, in partnership with Healthcare Access San Antonio (HASA, a regional HIE covering multiple regions in Texas), a local hospital partner, and Audacious Inquiry (Ai), will conduct a proof-of-concept pilot to demonstrate real-time, automated exchange of hospital capacity and other situational awareness data through APIs using HL7 Fast Healthcare Interoperability Resources (FHIR). This improved reporting will support the Texas Department of State Health Services.
These five awards represent a range of activities across different geographic regions of the country. The cooperative agreements will include cross-recipient collaboration to leverage their collective expertise and ensure the sharing of implementation experience gained from the program. This will bolster the likelihood of success and enable better replicability of the projects throughout the country.
By Patricia Hyle, vice president of product commercialization, StayWell.
Patricia Hyle
Fast Healthcare Interoperability Resources or FHIR was introduced in 2014 as a data standard for electronic health records to adopt, enabling improved access in sharing health data. The move was predicated by new standards set for the with the passing of the Affordable Care Act in 2015 but supports the standard framework for EHR systems to ensure patient information be accessible in an effort to deliver quality care.
FHIR aims to simplify implementation without sacrificing information integrity. It leverages existing patient models to provide a consistent, easy to implement, and rigorous mechanism for exchanging data between EHR applications. This move gained ground when it earned support and adoption from Epic and Cerner, two of the largest EHR systems in the industry. With more than 80 percent of hospitals and health systems now using EHRs on the FHIR platform, it has become the standard for EHR vendors to meet ONC certification criteria.
Addition of apps to FHIR
Following the adoption of FHIR as the new universal standard operating platforms for EHR systems, the launch of SMART (Substitutable Medical Applications, Reusable Technologies) quickly followed to enable to launch of apps within the FHIR platform. When the two platforms came together it became known as SMART on FHIR, allowing software engineers and clinicians to create open-source tools for app developers.
With the addition of these plug-in apps, clinicians can pick and choose which apps they want to integrate into their EHR system. This allows apps to use the standard type of data to build profiles, deliver tools, create reminders, or share data within a fully connected set.
One example of this type of app on is Krames On FHIR. Launched in 2017, this app delivers recommended patient education materials based on inputs from the patient’s EHR record. The material also includes video resources, interactive tools, and health tips that can be sent directly to patients via the patient portal and provides a patient engagement dashboard that allows physicians to track engagement for greater treatment adherence.
Impact of consumer applications to FHIR
When SMART on FHIR initially launched, it was intended to be a set of app standards for developing apps within the closed FHIR network. The end user would be interfacing with an EHR system, and ideally the end user was a care provider or administrator in a health care setting. However, after a few years of use, more users and developers saw the potential use of extending limited access to the network to the patient.
Health Level Seven International (HL7), announces the launch of the HL7 FHIR Accelerator Program. The program is based on a model piloted by the HL7 Argonaut Project and, more recently, the HL7 Da Vinci Project. The goal is to strengthen the FHIR (Fast Healthcare Interoperability Resources) standard and enhance market adoption through a programmatic approach available to myriad stakeholders.
Charles Jaffe, MD, PhD
“HL7 FHIR has achieved remarkable adoption on a global scale,” said Dr. Charles Jaffe, CEO of HL7. “An ever-growing community of implementers has emerged across a broad spectrum of health care, eager to participate in an agile onramp for FHIR adoption and implementation. The HL7 FHIR Accelerator Program provides the framework for that community to leverage the technical capability, management expertise and experience gained during the creation and growth of the Argonaut and Da Vinci Projects.”
Building on the success of current projects – Argonaut (provider-provider and provider-patient) and Da Vinci (payer-provider) – The CARIN Alliance has recently been approved as an HL7 FHIR accelerator project (payer-patient). The three projects are complementary initiatives.
“On behalf of the CARIN Alliance, its board and membership, we are grateful for the opportunity to work more closely with HL7 as part of the FHIR Accelerator Program as we work to develop additional FHIR implementation guides so consumers can get access to more of their health information,” said Ryan Howells, CARIN Alliance Project Manager and Principal at Leavitt Partners. “Consumers and their authorized caregivers are requesting more access to health care data with less friction to empower them to become more informed, shared decision-makers in the care they receive.”
The original concept behind accelerating HL7 FHIR began approximately four years ago with the advent of the Argonaut Project.
Guest post by Joanna Gorovoy, senior director product and solutions marketing, Axway.
Joanna Gorovoy, MBA
The healthcare industry is in the midst of digital transformation. At the same time, heightened government regulation, evolving healthcare policies and a rise in healthcare consumerism are driving a shift toward value-based, outcome-driven care models.
The focus on maximizing value and outcomes requires organizations across the healthcare ecosystem to work together, especially across a variety of different, and often unaffiliated organizations, including hospitals, health insurance companies, pharmacies and wearable health tech companies. Additionally, data silos and interoperability issues make it difficult to derive value from health data across ecosystems, provide quality patient care and optimize health outcomes.
Healthcare IT leaders in today’s digital era face a great opportunity and a daunting challenge: deriving value from massive volumes of healthcare data while meeting heightened demands for data privacy and security. In 2016 alone there were 106 major healthcare data breaches, exposing 13.5 million individuals’ records. As healthcare data breaches continue to rise in numbers, healthcare IT leaders must reevaluate how they approach key initiatives across patient engagement, population health management and care coordination.
They need to provide secure and innovative digital experiences by implementing application program interfaces (APIs), which are a set of routines, protocols and tools for building software applications, and increase awareness of industry standards, such as Health Level Seven International’s (HL7) Fast Healthcare Interoperability Resources (FHIR). Doing these two things will provide assistance in addressing interoperability issues and simplify the exchange of health information across the ecosystem.
But it doesn’t stop there. Moving toward a future where healthcare data is more widely accessible will require greater security management across all organizations that have access to patient data. To create a more secure and scalable foundation for digital innovation in healthcare you must follow these three steps:
Guest post by Pawan Sharma, director of operations for healthcare at Chetu.
Pawan Sharma
Healthcare is quickly adapting to the digital environment by leveraging web-based technologies, electronic health records (EHR) and mobile devices to facilitate the movement of information. With innovative software technology comes great responsibility. One of the unfortunate downsides to increasing the use of technology for data sharing in the healthcare world is the risk of data falling into the wrong hands. Full measures need to be put in place to protect patient’s Protected Health Information (PHI). The Health Insurance Portability and Accountability Act (HIPAA) mandates that all PHIs be secured. Any breach, if not handled appropriately under established procedures, can lead to grave consequences including heavy penalties, jail time, or both. Needless to say that proper mechanisms need to be implemented to secure data while it is stored, transmitted and consumed.
Understanding Regulatory Standards
Knowledge is power. It is paramount that software providers look for back-end development partners that have Healthcare IT experience. This includes extensive knowledge and proficiencies with federal regulations like American Recovery and Reinvestment Act (ARRA), meaningful use stage 1 and 2, Accountable Care Act, etc. Also, regulatory health information exchange (HIE) standards such as Health Level 7 (HL7), Health Information Exchange Open Source (HIEOS), Fast Healthcare Interoperability Resources (FHIR), Consolidated-Clinical Document Architecture (C-CDA), Continuity of Care (CCD/CCR) as well as clinical and financial work flows.
Encryption
With information traveling over a network it may be subject to interference. Hence, it is important that data be encrypted in transit. Vendors must include encryption technology to prevent disclosure of patient health information while data is communicated between the application and the server. Web traffic must be transmitted through a secure connection using only strong security protocols such as Secure Sockets Layer (SSL) or Transport Layer Security (TLS). SSL/TLS certificates are light weight data files that are purchased and installed directly onto the server. Once implemented, a user will be able to connect to the web-based application server via a secure tether with an internet browser.
Code Hardening
Organizations have been keen on securing networks and internal infrastructure from external threats. With this in mind, malicious entities are looking to breach data at the application level. Healthcare software proprietors must protect their application from security threats by employing hardening tactics, which shields bugs and vulnerabilities in the coding. This technique primarily includes code obfuscation. Code obfuscation is the act of intentionally creating obscure source code to make it difficult for entities to decipher. Properly employing this tactic hinders a threats ability to reverse engineer and tamper with an application to facilitate a breach.
