By Janak Joshi, senior vice president, chief technology officer and head of strategy, Life Image.
In December 2018, the FDA announced its new framework for the real world evidence (RWE) program, which would require including imaging data alongside claims, electronic health records (EHRs) and other datasets in clinical research. In issuing this new framework, regulators underlined the continued importance of using contextualized, quality datasets to make drug development faster, safer, more efficient and less expensive.
Because of this move to include authentic patient data in the drug development process, imaging data has become an essential part of RWE as it can accelerate the development cycle and improve the confidence in the final clinical arguments in support of drugs going to market.
Imaging data plays such a leading role in clinical decision-making because it is the most advanced diagnostic evidence for several diseases, and it can clearly show disease progression and drug impact across a variety of therapeutic areas, among other reasons. While EHRs and medical claims are the predominate sources of data, because they were initially designed for billing and payment purposes they do not have the depth and breadth needed to accurately capture the nuances of a patient’s full clinical history – nor do they contain imaging information.
Clinical researchers looking to achieve a holistic view of each patient’s healthcare journey by incorporating medical imaging into their RWE programs should avoid these three things.
Institutional bias stems from using data from a single health system, which tends to follow a uniform set of treatment protocols, leading to homogenous evidence data. A diverse dataset includes variation, for instance in geography, which can influence socioeconomic and environmental factors, level of education, healthcare access, payer mix and demographics.
The most effective RWE incorporates medical data, including imaging, from varied populations that include both research and non-research settings, AMCs and community hospitals, publicly and privately funded institutions, and a mix of highly insured and uninsured patients. The ultimate goal of RWE is to be representative of any and all patients across the globe.
A limited, siloed data pool
Small datasets do not accurately reflect the “real world,” therefore RWE requires very large databases with various datasets in order to ensure data integrity and credibly match patients to appropriate clinical trials. This poses a challenge since much of today’s data is siloed. To make RWE representative of outcomes and context, clinical researchers must break down siloes to achieve a large, interoperable pool of quality data from a breadth of sources, which they can normalize and match across sets for optimal results.
Take, for example, a new drug trial that needs to involve 500 individuals meeting specific real-world data standards. For each participant, researchers may require four years of prescription details, four years of imaging data, five years of blood test results, as well as genomics and other relevant data. However, consider that over the years many of these patients likely went to various pharmacies, switched health plans and/or providers, and had imaging and blood tests performed at various facilities or out-of-network sites. As a result, each patient’s information may be spread out over multiple EHR systems and may even be in non-digital, fax or CD formats.
The Department of Health and Human Services (HHS) filed its annual year-end report to Congress at the start of 2019. The 22-page report summarized nationwide trends in health information exchange in 2018, including the adoption of EHRs and other technologies that support electronic access to patient information. The most interesting takeaway has to do with the ever-elusive healthcare interoperability.
According to the report, HHS said it heard from stakeholders about several barriers to interoperable access to health information remain, including technical, financial, trust and business practice barriers. “These barriers impede the movement of health information to where it is needed across the care continuum,” the report said. “In addition, burden arising from quality reporting, documentation, administrative, and billing requirements that prescribe how health IT systems are designed also hamper the innovative usability of health IT.”
To better understand these barriers, HHS said it conducted multiple outreach efforts to engage the clinical community and health IT stakeholders to better understand these barriers. Based on these takeaways, HHS said it plans to support, through its policies, and that the health IT community as a whole can take to accelerate progress: Focus on improving interoperability and upgrading technical capabilities of health IT, so patients can securely access, aggregate, and move their health information using their smartphones (or other devices) and healthcare providers can easily send, receive, and analyze patient data; increase transparency in data sharing practices and strengthen technical capabilities of health IT so payers can access population-level clinical data to promote economic transparency and operational efficiency to lower the cost of care and administrative costs; and prioritize improving health IT and reducing documentation burden, time inefficiencies, and hassle for health care providers, so they can focus on their patients rather than their computers.
Additionally, HHS said it plans to leverage the 21st Century Cures Act to enhance innovation and promote access and use of electronic health information. The Cures Act includes provisions that can: promote the development and use of upgraded health IT capabilities; establish transparent expectations for data sharing, including through open application programming interfaces (APIs); and improve the health IT end user experience, including by reducing administrative burden.
“Patients, healthcare providers, and payers with appropriate access to health information can use modern computing solutions (e.g., machine learning and artificial intelligence) to benefit from the data,” HHS said in its report. “Improved interoperability can strengthen market competition, result in greater quality, safety and value for patients, payers, and the healthcare system generally, and enable patients, healthcare providers, and payers to experience the promised benefits of health IT.”
Interoperability barriers include:
Technical barriers: These limit interoperability through—for example—a lack of standards development, data quality, and patient and health care provider data matching. Addressing these technical barriers by coordinating to establish the technological foundation for standardizing electronic health information and by promoting exchange of that information can considerably remove these barriers.
Financial barriers: These relate to the costs of developing, implementing, and optimizing health IT to meet frequently changing requirements of health care programs. The cost to adjust health IT to meet these requirements can impact innovation and the timeliness of technical upgrades. Specific barriers include the lack of sufficient incentives for sharing information between health care providers, the need for enhanced business models for secondary uses of data, and the current business models for health systems or health care providers that do not adequately focus on improving data quality.
Trust barriers: Legal and business incentives to keep data from moving present challenges. Health information networks and their participants often treat individuals’ electronic health information as an asset that can be restricted to obtain or maintain competitive advantage.
Elsewhere, the Center for Medical Interoperability, located in Nashville, Tenn., is an organization that is working to promote plug-and-play interoperability. The center’s members include LifePoint Hospitals, Northwestern Memorial Healthcare, Hospital Corporation of America, Cedars-Sinai Health System, Hennepin Healthcare System, Ascension Health, Community Health Systems, Scripps Health, and UNC Health Care System.
Its mission is “to achieve plug-and-play interoperability by unifying healthcare organizations to compel change, building a lab to solve shared technical challenges, and pioneering innovative research and development.” The center stressed that the “lack of plug-and-play interoperability can compromise patient safety, impact care quality and outcomes, contribute to clinician fatigue and waste billions of dollars a year.”
More interoperability barriers identified
In a separate study, “Variation in Interoperability Among U.S. Non-federal Acute Care Hospitals in 2017,” showed additional difficulty integrating information into the EHR was the most common reason reported by hospitals for not using health information received electronically from sources outside their health system. Lack of timely information, unusable formats and difficulty finding specific, relevant information also made the list, according to the 2017 American Hospital Association (AHA) Annual Survey, Information Technology Supplement.
Among the explanations health systems provided for rarely or never using patient health information received electronically from providers or sources outside their health system:
Difficult to integrate information in EHR: 55 percent (percentage of hospitals citing this reason)
Information not always available when needed (e.g. timely): 47 percent
Information not presented in a useful format: 31 percent
Information that is specific and relevant is hard to find: 20 percent
Information available and integrated into the EHR but not part of clinicians’ workflow: 16 percent
Hospitals, when asked to explain their primary inability to send information though an electronic exchange, pointed to: Difficulty locating providers’ addresses. The combined reasons, ranked in order regardless of hospital classification (small, rural, CAH or national) include:
Difficult to find providers’ addresses
Exchange partners’ EHR system lacks capability to receive data
Exchange partners we would like to send data to do not have an EHR or other electronic system to receive data
Many recipients of care summaries report that the information is not useful
Cumbersome workflow to send the information from our EHR system
The complexity of state and federal privacy and security regulations makes it difficult for us to determine whether it is permissible to electronically exchange patient health information
Lack the technical capability to electronically send patient health information to outside providers or other sources
The report also details other barriers related to exchanging patient health information, citing the 2017 AHA survey:
Greater challenges exchanging data across different vendor platforms
Paying additional costs to exchange with organizations outside our system
[Need to] develop customized interfaces in order to electronically exchange health information
“Policies aimed at addressing these barriers will be particularly important for improving interoperable exchange in health care,” the report concluded. “The 2015 Edition of the health IT certification criteria includes updated technical requirements that allow for innovation to occur around application programming interfaces (APIs) and interoperability-focused standards such that data are accessible and can be more easily exchanged. The 21st Century Cures Act of 2016 further builds upon this work to improve data sharing by calling for the development of open APIs and a Trusted Exchange Framework and Common Agreement. These efforts, along with many others, should further improvements in interoperability.”
What healthcare leaders are saying about interoperability
While HHS said it conducted outreach efforts to engage health IT stakeholders to better understand these barriers, we did too. To further understand what’s currently going on with healthcare interoperability, read the following perspectives from some of the industry’s leaders. If there’s something more that you think must be done to improve healthcare interoperability, let us know:
How many doctors have you seen in your lifetime? Don’t know or remember? You’re not alone – the average American patient will see nearly 19 different doctors during their lifetime. Nineteen different offices. Nineteen different medical charts. Nineteen different phone numbers. Nineteen different calls to track down your records. Now, can you even remember your last five doctors?
The future: Imagine this, you visit your doctor – or any doctor for that matter – and they quickly pull up your medical history. Vaccinations when you were a child? Check. Currently on a hypertensive medication? Check. Pre-disposed to a medical condition? Yep, that’s in there, too. No more arriving 20 minutes early to the doctors’ office to fill out the industry-average seven pages of paper forms. Your records – past and present – are already being reviewed by your trusted provider.
Beyond the sheer convenience, the accuracy and completeness of having your entire medical history available at the fingertips of your provider can impact your well-being and scope of care. Can you accurately remember all procedures you’ve had? And when? Or all the medications you’ve ever taken? With dates? Imagine if you were a senior. Not just daunting, but nearly impossible. Instead of going over just snippets of what you actually remember, your doctor is empowered to holistically review your entire medical history with the potential to make more informed decisions about your health.
Seem like a pipedream? If you were to ask a mere decade ago, most would have agreed. As recently as 2007, 88 percent of physicians were still charting on paper. And those physicians on an EHR system – who were paying a premium – were almost exclusively using a localized, server based platform with no connectivity. For cost perspective, according to HealthIT.gov, the average upfront cost of implementing an EHR is $33,000 per provider plus an on-going fee of $4,000 yearly, a cost-prohibitive amount for most private practices.
Fast forward to 2009 and the passage of the HITECH Act which provided billions of dollars of incentives for providers to implement an electronic health record. In addition to the incentives, new vendors appeared on the market who provided electronic health record platforms completely free-of-charge, allowing providers to reinvest the incentives in their practice as additional staff, new equipment, etc.
Interoperability between healthcare’s disparate systems seems to be the stickiest of wickets, and a Holy Grail that every soul in the sphere is trying to find. Given the number of conversations about the topic, there’s often little discussed about its actual importance. Perhaps this is an assumed measure or an outcome that should be clearly understood as positive, but every relevant aspect of every story should be covered, not simply assumed. Because far better reporters and publications have done a far better job of describing the interoperability issue and its place in the current healthcare landscape, I decided to ask one question of the community, in an search of a foundational answer to: How is interoperability critical to healthcare innovation?
The prospective provided here, from some of healthcare’s most knowledgeable insiders, offers some interesting insight into a topic that seems more or less overlooked in the larger conversation of achieving interoperability or its capabilities.
Rick Valencia, senior vice president and general manager, Qualcomm Life Interoperability is the future of healthcare innovation, especially as we move toward an era of connected, team-based care. We need to create platforms and devices that enable the seamless, frictionless flow of data to allow doctors, patients, providers and care teams to collaborate efficiently to make critical care decisions. As care moves from the hospital to the home and more patients are remotely monitored, we need solutions that enable continuous care, informed interventions, and better management of at-risk populations. Without interoperability, we can’t innovate. Without innovation, we can’t improve the health of our nation.
Interoperability is critical to innovation in healthcare IT, particularly when it comes to connecting the care delivery ecosystem to provide safer transitions of care between acute and senior care. While some individuals may require short-term rehabilitative care, others may need home-based care, assisted living or long-term and hospice care. As seniors move through these different stages or between acute care and post-acute care, these transitions pose challenges for healthcare providers. Ideally, all the information that clinicians need to treat the individuals will be available when they arrive at their new destination. However, this is not always the case. Healthcare providers must invest in an infrastructure and emerging technologies, such as electronic health records and mobile communications, which support seamless transitions; interoperability plays a vital role. Compared to single-purpose or “best-of-breed” software solutions, comprehensive platforms can optimize many parts of the business, from enabling better-connected resident care and documentation, to delivering high quality data insights for financial management and risk mitigation. In the end, this will allow for better health outcomes, help reduce unnecessary hospital readmissions, ensure organizations are financially sound and keep healthcare costs down.
Interoperability in healthcare is critical for doctors to coordinate care for their patients and improve their health. However, if physicians are using proprietary software in their offices, interoperability becomes a very difficult and very expensive challenge. Without interoperability in healthcare, doctors cannot guarantee the data they sent to a specialist will be received or interpreted properly. Today, doctors have to rely on fax machines to exchange patient information. This is an outdated and un-secure form of communication to exchange patient information.
At the center of all this is the patient, whose medical records containing their most sensitive information is traversing across fax lines. ELXR Health will change healthcare by giving physicians a new way to coordinate care and exchange information. With the platform, patients can create and manage their medical consents anywhere on a smartphone or tablet. ELXR Health can transform and translate health data into multiple formats; doctors can seamlessly exchange patient information regardless of the EHR software they sent to, or receiving from.
The ELXR Health platform is cloud-based engine that translates and restructures electronic health records into a format easily readable by any doctor’s office. We center our solution around the patient by providing them a responsive web application to create and manage their consents. This doctor-patient collaborative system will improve coordination of care systems and dramatically increase patient outcomes.
Paul Emanuel, HCISPP, is the co-founder and CEO of ELXR Health. Emanuel has worked in healthcare technology for many years as a technician, a systems and security administrator, an EMR consultant and an HIE Engineer. His years of service in health IT enabled him to receive 14 IT certifications, and is a certified healthcare information security and privacy practitioner. He started his first company in 2008 helping rural health clinics adopt electronic health records and connect with state health information exchanges. He came up with his idea for ELXR Health from his years of experience in Health IT. ELXR Health was created to be the solution for doctors and patients to better coordinate care.
Marketing/promotion strategy Behavioral health organizations, managed care organizations, hospitals and private practices are looking for a cost-effective way to exchange patient data electronically while improving patient outcomes while adhering to their state laws. Our engine allows doctors to translate, restructure and validate health data so the data being sent is the data being received.
ELXR Health gives the patient the ability to manage their consents at their convenience from their smartphone or tablet. We also give developers the ability to integrate with our API to improve their software and provide better care systems for doctors and patients.
The College of Healthcare Information Management Executives (CHIME), the professional organization for chief information officers and senior IT executives, is calling on innovators throughout the U.S. to participate in the CHIME National Patient ID Challenge.
In an effort to find a universal solution for accurately matching patients with their healthcare information, CHIME will launch a $1 million challenge early this summer on the HeroX platform, co-founded by XPRIZE CEO Dr. Peter Diamandis.
The digitization of the U.S. healthcare system maintains that electronic health records must be able to seamlessly share and exchange information. According to CHIME, interoperability is not enough — to realize their full potential, patient data contained in the EHR must be accurate to support the requirements of coordinated, accountable, patient-centered care, the organization says.
“There is a growing consensus among payers and providers that a unique patient ID would radically reduce medical errors and save lives,” said CHIME CEO and president Russell P. Branzell, FCHIME, CHCIO.”Incomplete or duplicate health records present significant issues in terms of patient safety, and there is a pressing need for preventing, detecting and removing inaccurate records so hospitals can positively match the right data with the right patient in order to provide the best possible care.”
Duplicate or inaccurate patient records can occur from manual data entry errors, or when two or more individuals share the same name. This presents considerable concern for different individuals being identified as the same patient, potentially resulting in inadequate treatment or unintended injury.