Regulatory changes in healthcare often arrive like sudden disruptions, throwing clinical workflows out of sync and distancing patients from quality care. Yet these regulations provide the crucial pathway towards ensuring patient safety and enabling excellence in healthcare delivery. The challenge for physician-owned health systems and smaller community hospitals intensifies as they must weather these regulatory storms while operating efficiently across disparate systems and infrastructures.

To truly grasp the profound impact of regulations, one must recognize their vital significance in safeguarding patient welfare. Like lighthouses guiding ships through turbulent storms at sea, healthcare regulations serve as indispensable guardrails on the delivery highway, directing providers toward practices that uphold the pillars of safety, efficacy, and ethical conduct.

In an era dominated by digital innovation, interoperability becomes our guiding compass, facilitating seamless data exchange and communication among diverse systems and stakeholders.

Let’s explore this analogy further:

Navigating Healthcare’s Seas: Envision healthcare as a vast ocean, with patients and providers navigating its waters. Regulatory changes act as powerful currents and tides, influencing the direction and pace of this journey. Without these regulatory guardrails, healthcare delivery could become akin to sailing without a compass, risking patient safety and compromising the quality of care.

Guardrails of Patient Safety: Just as guardrails prevent vehicles from veering off dangerous cliffs, regulations establish crucial boundaries to ensure patient safety remains the top priority. They meticulously dictate standards for documentation, medication protocols, treatment practices, and more, guiding healthcare providers toward practices that prioritize patient well-being above all else.

Highway of Delivery: Picture healthcare as a bustling highway, with patients moving along the lanes toward their respective destinations. Regulatory changes shape this highway, determining the speed limits, road signs, and traffic rules governing the journey. By diligently adhering to these regulations, healthcare providers ensure a smooth and safe passage for patients, minimizing risks and maximizing positive outcomes.

Consistent Care Delivery: Envision healthcare as a relay race, with the baton of care being passed from one provider to another. Regulations establish the rules of this race, ensuring that the baton is passed smoothly and efficiently without any hiccups or mishaps. By adhering to these regulations, healthcare providers maintain a consistent level of care delivery, ensuring that every patient receives the same high standard of quality treatment, regardless of where they are on their healthcare journey.

Accountability and Transparency: Regulations promote accountability and transparency within the healthcare system. They require healthcare providers to adhere to strict documentation standards, ensuring that every decision and action is recorded and traceable. This transparency fosters trust and confidence between patients and their care providers, bolstering the crucial patient-provider relationship.

However, the ever-shifting regulatory landscape poses significant challenges, especially for community and physician-owned health systems with varying infrastructures and limited resources. Picture these healthcare institutions as a fleet of ships, each navigating its course through turbulent seas, where fragmented communication and data silos hinder the seamless delivery of optimal patient care.

To successfully navigate the regulatory maze while maintaining compliance and operational efficiency, health systems can employ strategic approaches:

• Embrace Innovation: Foster a culture of innovation within the organization, encouraging the exploration of novel solutions to regulatory hurdles. Streamline processes, enhance data security, and improve patient outcomes by leveraging emerging technologies such as AI and ML.

• Forge Strategic Partnerships: Cultivate collaborative relationships with regulatory agencies, professional organizations, and peer institutions. By sharing insights, best practices, and collective intelligence, health systems can strengthen their compliance efforts and navigate regulatory complexities more effectively through mutual support.

• Prioritize Patient-Centric Practices: Anchor every decision and action into the needs and preferences of patients. Implement personalized care plans, telehealth services, and other patient-centric initiatives to enhance patient engagement, satisfaction, and overall outcomes, fostering a culture of empowerment and partnership in healthcare delivery.

Furthermore, staying informed and maintaining vigilance is paramount in the face of regulatory changes. Just as navigators watch the horizon, healthcare systems must cultivate a culture of continuous learning and proactive compliance monitoring. By proactively anticipating regulatory shifts and mitigating risks, they can optimize their compliance efforts and adapt swiftly to emerging mandates.

In an era dominated by digital innovation, interoperability becomes our guiding compass, facilitating seamless data exchange and communication among diverse systems and stakeholders. Investing in integrated EHR systems is not merely a choice but a necessity, enabling healthcare organizations to navigate the regulatory seas with agility, precision, and foresight, ultimately reaching the shores of greatness in patient care delivery.

Collaboration also plays a crucial role in keeping health systems afloat during regulatory turbulence, providing them with an anchor to stand on during their regulatory journeys. By forging strategic partnerships with regulatory agencies, professional organizations, and peer institutions, health systems can share best practices, learn from collective experiences, and navigate common obstacles together, strengthening their resilience and adaptability.

Regulatory shifts in healthcare profoundly impact physicians, akin to navigating turbulent seas where each wave presents a new challenge. The enactment of legislation like the Health Information Technology for Economic and Clinical Health Act (HITECH) exemplifies this analogy vividly. HITECH’s primary objective was to revolutionize healthcare delivery by incentivizing the widespread adoption of EHRs, promising to usher in an era of enhanced patient care quality and efficiency.

However, the journey towards integrating EHR systems into medical practice was fraught with obstacles. Physicians encountered the daunting task of mastering unfamiliar interfaces and grappling with increased documentation burdens, threatening to disrupt established workflows and patient care routines that had been finely tuned over years of experience.

Dr. Atul Gawande, a renowned author and authority in healthcare compliance and innovation, emphasizes the importance of adopting a strategic and proactive approach to navigate regulatory transitions effectively. In his book, “The Checklist Manifesto,” he advocates for comprehensive training programs, robust support mechanisms, and a culture of continuous improvement to empower physicians in embracing change and leveraging regulatory mandates as catalysts for driving positive outcomes for patients. Through proactive adaptation and a steadfast commitment to excellence, physicians can weather regulatory storms and chart a course toward a brighter future in healthcare delivery.

As we embark on the future of healthcare delivery, let us draw wisdom from ancient mariners and modern navigators alike. The famous American rock band, The Doors, inadvertently suggested the right kind of wisdom applicable to healthcare readiness and ever-evolving regulations—”Keep our eyes on the road and hands upon the wheel”—to “Break on through the other side” of regulatory change with grace and confidence, heading towards an improved health and wellness outlook for all!

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Interoperability enables the exchange of data from different healthcare providers, patients, and other stakeholders to access and share relevant medical information across various platforms and settings, regardless of the system or vendor they are using. Addressing interoperability challenges in healthcare requires a multifaceted approach involving technology, standardization, and collaboration.

What can Stakeholders expect from healthcare interoperable systems?

Interoperable systems enable seamless communication and data exchange among healthcare providers, facilitating better coordination of patient care across different settings and specialties. This leads to more informed decision-making, reduced duplicate testing, and enhanced continuity of care. These systems help reduce errors and adverse events by ensuring that accurate and up-to-date patient information is readily available to clinicians at the point of care, including medication lists, allergies, medical history, and other critical data that can impact treatment decisions and patient outcomes. Interoperability streamlines administrative and clinical workflows by automating data exchange and eliminating manual processes. This allows clinicians to focus more on patient care and less on paperwork.

Interoperable systems enable the aggregation and analysis of healthcare data from multiple sources, leading to valuable insights into population health trends, disease management, and treatment outcomes. Stakeholders can identify patterns, monitor performance, and make data-driven decisions to improve healthcare delivery and outcomes. Interoperable systems empower patients to become more active participants in their healthcare journey by providing access to their health information and enabling communication with their healthcare providers.

Unlocking seamless healthcare: The power of interoperability.

Healthcare interoperable systems often support integration with third-party applications and devices, allowing seamless connectivity and interoperability across the healthcare ecosystem. This includes patient portals, mobile health apps, wearable devices, remote monitoring tools, and telemedicine platforms, expanding access to care and enabling innovative healthcare delivery models.

Key problems with interoperability in healthcare

Interoperability in healthcare faces several key challenges that hinder seamless communication and data exchange among healthcare systems and stakeholders. Some of the key problems include:

Avalanche of Standards: One of the primary barriers to interoperability is the stream of standardized data formats, terminologies, and communication protocols. Variability in data structures and coding systems makes it difficult for systems to interpret and exchange information accurately, leading to interoperability gaps and data fragmentation.

Legacy Systems and Infrastructure: Many hospitals still rely on legacy systems that were not designed with interoperability in mind. These systems may use outdated technologies, proprietary formats, or closed architectures that hinder data exchange and integration with modern interoperable solutions.

Data Privacy and Security Concerns: Healthcare data is highly sensitive and subject to stringent privacy and security regulations, such as HIPAA (Health Insurance Portability and Accountability Act) in the United States. Ensuring secure transmission and storage of patient information while maintaining compliance with regulatory requirements adds complexity to interoperability efforts and may limit data sharing.

Cost and Resource Constraints: Implementing interoperable systems and standards requires significant investments in technology, infrastructure, and personnel. Many healthcare organizations, especially smaller providers and rural facilities, may lack the resources or expertise needed to upgrade their systems and achieve interoperability effectively.

Fragmented Governance and Incentives: The lack of cohesive governance structures and aligned incentives across the healthcare ecosystem poses challenges to interoperability initiatives. Different stakeholders may have conflicting priorities or lack incentives to invest in interoperability, leading to fragmented efforts and slow progress.

Vendor Lock-in and Proprietary Solutions: Some healthcare IT vendors offer proprietary solutions that lock organizations into their ecosystems, limiting interoperability with other systems and vendors. This vendor lock-in creates barriers to data exchange and interoperability, hindering innovation and competition in the healthcare IT market.

User Resistance and Workflow Disruption: Healthcare professionals may resist interoperability initiatives due to concerns about workflow disruption, increased workload, or perceived usability issues with new systems.

Overcoming resistance and gaining buy-in from end-users are critical for successful interoperability implementation and adoption. Following is our hospital’s interoperability expedition:

Implementing Health Information Technology (HIT) Standards for Interoperability: Adherence to standards such as HL7 (Health Level Seven), FHIR (Fast Healthcare Interoperability Resources), and DICOM (Digital Imaging and Communications in Medicine) ensures that systems can communicate effectively with each other. Hospitals must prioritize to assess current state and needs, select appropriate HIT standards and integration engines that act as intermediaries between disparate systems, enabling data translation and communication, develop implementation plans, update policies and procedures, test and validate implementation, monitor and maintain compliance, promote adoption and collaboration of these standards in IT infrastructure.

Promoting Data Governance and Quality Assurance: Establishing robust data governance policies ensures that patient information is accurate, consistent, and secure across different systems. Quality assurance measures help identify and resolve data discrepancies, enhancing the reliability and usefulness of interoperable data.

Training and Education for Staff: Healthcare professionals need to be proficient in utilizing interoperable systems and understand the importance of data exchange in improving patient care. Provide comprehensive training programs to ensure that staff members are equipped with the necessary skills and knowledge.

Engaging in Collaborative Initiatives: Collaboration among healthcare stakeholders, including hospitals, payers, technology vendors, and regulatory bodies, is essential for accelerating interoperability initiatives. Participation in collaborative projects and industry consortia can help hospitals stay updated on best practices and emerging standards.

Continuous Evaluation and Improvement: Interoperability efforts should be subject to ongoing evaluation and refinement. Regularly assess the effectiveness of interoperability strategies, solicit feedback from end-users, and implement improvements based on evolving technology and regulatory requirements.

By addressing these challenges, hospitals can overcome barriers to interoperability and unlock the full potential of connected health information systems to improve patient care and outcomes.

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Healthcare’s primary problem is not the lack of data, but the lack of fidelity and usability of the available data. The challenge is collating, interpreting, and distilling data to a usable state and getting those data to the right person, at the right time. Additionally, healthcare data is unwieldy and fractured, continuing to fracture exponentially as more care channels and options emerge. New channels generate new data silos that make safe, effective care difficult. Compounding this issue, costs of health insurance, care delivery, and medications continue to rise, placing adequate healthcare out of reach for many. As a result, the quality of care across the US continues to lag significantly behind other countries.

Patients are the reason healthcare exists, and yet, they are rarely centered in their information or care.

Also, the US healthcare is experiencing an unprecedented period of change, brought on by industry pressures, which makes an already complex system more cumbersome and perilous.

These pressures include: 

• Dramatic shifts in consumer expectations: Younger consumers are not satisfied with traditional healthcare, and consumers of all age groups are more willing than ever to try non-traditional services. Millennials and gen Z, who make up 42% of the population and 21% of healthcare services, expect convenience, affordability, transparency, and quality and are redefining how they engage in every stage of their care.
  
  
• Fragmentation: The delivery of care through established service paths (e.g., doctors, clinics, and medical centers) must now compete with non-traditional service paths that represent emerging types of service delivery (e.g., walk-in or retail clinics, outpatient surgery hospitals, virtual health, on-demand services, in-home services, or digital therapeutics).
  
  
• Increased regulatory pressures: The burden of new and existing laws regulating healthcare—such as HITECH, HIPAA, ACA, FDASIA, and MACRA/MIPS—affects providers by increasing their administrative load and by adding or increasing penalties for services that do not meet a set of prescribed quality, interoperability, and performance criteria. These burdens slow the delivery of care and reduce patient interface time with doctors and their clinical staff, alongside a host of other factors that can negatively impact care delivery, patient outcomes, and provider reimbursement.
  
  
• Hyper-specialization as the knowledge about diseases accelerates: Medical research continues to reveal the complexity behind disease causes and treatments. As research unravels the genome, microbiome, and proteome, referred to as multiomics, to understand their role in health and wellness, physicians become more specialized to turn discoveries into better outcomes for patients.
  
  

Data is duplicated and conflicting due to issues with standards

Because most health record systems do not consolidate information, numerous patient and provider-reported health records result in duplication, retention of outdated information, and leave room for error. Also, payer data often inaccurately reflects patient care and services provided due to the complicated nature of billing practices. Often, to ease workflow, patient services are billed based on a short list of memorized codes or the first code to populate a search, resulting in loss of fidelity. Therefore, providers don’t uniformly have access to accurate reference records which creates an overwhelming burden on providers trying to find the information needed to make recommendations.

Projects to enable interoperability are costly and time-consuming

Traditional data transformation and sharing methods are complex and deduplicating of the data with any precision is time-consuming and risky. Important changes in a patient’s record can take weeks or even months to emerge, as the data integration does not happen in near real time. There are existing methods of sharing more cleanly within like EMRs, but even in that method, there are issues reconciling data due to the differences in system setup (x field in system A is blood pressure, whereas it’s y field in system B).

The patient is never in control of their data

Patients are the reason healthcare exists, and yet, they are rarely centered in their information or care. They have little control of their data and, in most cases, have no concept of how the data is used and where it’s shared. Also, all too often, patient-provided information fails to be integrated with the patient’s record thereby ignoring critical pieces of information. By ignoring the patient as a vital part of healthcare and its interoperability, data sharing and cleansing become complex and diminishes the capabilities of healthcare providers to make data-based diagnoses and treatment decisions.

What can and should be done?

We should strive for a single, golden record for every person on Earth that is updated in real-time as changes happen and allows for notification of significant events to be delivered to the right person at the right time. And that record should be owned by the individual, not the system.

There have been many barriers to this in the past, but the most significant challenge has been to uniquely identify each person and all of the entities and assets they interact with.

Luckily, technologies and tools emerging on the market now can systematically address these issues through AI and machine learning. Tasks considered nearly impossible, like merging 20 medical records and distilling the information down to a single record, can now be done at scale, with the patient owning the overall outcome.

One emerging company consolidates health and wellness data into a single, standardized record under secure control of the patient that facilitates seamless data exchange amongst healthcare and life science constituents. The technology leverages syntactic, structural, and semantic interoperability techniques in addition to patient-level interventions when AI cannot resolve the data cleansing automatically.

In addition to focusing on rich medical data, this company continuously fills gaps with real-time, real-world data from multiple sources (e.g., wearable and medical devices), in conjunction with social determinants of health (SDOH) and patient-reported information.

How do we get there?

While companies like this are working to solve this problem, there are cultural barriers in the US that need to be overcome. To truly achieve patient-owned interoperability, data hoarding and profiteering concepts need to be addressed. Healthcare needs to be democratized for a more equitable landscape. Platforms that democratize health information shift people from passive to active participants within their own health outcomes. After all, it is ultimately the patient that bears the burden of adverse health outcomes, not the providers.

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Virtual care is the intersection of telemedicine, remote patient monitoring (RPM), and analytics that drives necessary care for patients. The potential impact of virtual care is immense that not only impact the overall health of a patient or community but also have financial, quality, and accessibility impact. The current, rapid evolution of healthcare will change the experience of healthcare for generations to follow. When done effectively, virtual care will create a lasting, scalable impact on healthcare that will improve health for patients all around the world. However, it is important to focus on both the challenges and opportunities to create meaningful and sustainable change. While these changes are developing rapidly, many might be resistant to the speed or direction of these technological progressions. Change management can be very detrimental to any industry when poorly managed. As a sector, virtual care is still immature, so it is critical that reflection drives maturity.

Consistency of technology quality and reliability is fundamental in leveraging the power of virtual care.

User Experience

Prioritizing user experience is essential when any new technology or service is delivered. When done well, virtual care can be beneficial to drive engagement and provide timely care. However, the industry has seen so many different innovations that it can be difficult to create a seamless experience while integrating all these new technologies. With various tools available for patients, it can often be confusing to choose the right tool or even understand how to use each different tool. Training and support is required to help patients navigate technology and given the vast discrepancy in technological literacy, there are varying levels of training and support required. 

The same can be said for the clinical care team and providers. Because these individuals are focused on clinical care, new and unknown technologies can often be a barrier to care, especially if the onboarding is done poorly. Therefore, it is essential that the care team get adequate training prior to implementing new technology and are consistently supported. These steps will help ensure the technology creates the intended experience. 

For virtual care to drive healthcare forward, it is critical that the technology be easy and efficient to use for all, the provider and patient. A poor experience will be a barrier to positive health outcomes and a burden for the users.

Quality and Reliability

Virtual care combines various forms of technology to enhance the delivery of care to patients; however, at times, the technology can lack quality, consistency and reliability. Any technology should be routinely monitored and maintained by technology specialists to verify it is working properly and ensure that this burden does not fall on the patient or care team. The patient and care team should use virtual care to augment their ability to deliver care, but the clinician’s focus should always be on healthcare, not technology. Technology should not be invasive to the ability to focus on health treatment. Instead, it should be seen as a tool to improve care. The intersection of data and medical technology allows for the use of artificial intelligence (AI) and data science in ways not historically utilized to create efficiency and personalized healthcare.

The overwhelming amount of new technology in healthcare has also allowed the use of devices that do not meet medical quality or reliability, driving poor experience. It is essential that devices used for virtual care meet or exceed the quality level of those used in direct care. This includes the quality of video and sound, as well as the consistency of monitoring devices. The use of AI is extremely powerful. However, if the data feeding the algorithms are not accurate, the outcome will be compromised. Inaccurate data will lead to inferior quality care and poor reliability for technology, negating the enormous potential to improve healthcare. 

Consistency of technology quality and reliability is fundamental in leveraging the power of virtual care. Healthcare organizations should focus on using medical-grade technology that can operate reliably in order to drive innovation. 

Interoperability & Timely Meaningful Data

Interoperability of different tools is an imperative part of utilizing virtual care to deliver an enhanced experience for patients and providers. As it stands now, many technologies do not create an interoperable experience, leading to friction. This friction limits the ability to use technology effectively as it delays timely and valuable insights. As a result, data loses its value when there is not enough data or when there is so much data that it becomes incomprehensible.

For the patient, data overload can lead to confusion or feeling overwhelmed, making the technology not beneficial. The opposite, a lack of data availability, can lead to mistrust in the system and drive disengagement for patients. There are similar parallels for the care team; an overload of data can lead to care inefficiency, while the lack of available data can lead to poor care. Interoperability of systems is vital to ensure that all the data can be used in combination and that the data and insights are structured in a way that can be quickly and easily understood for effective, timely care.

In summary, to drive virtual care forward and improve the efficiency and quality of healthcare, there must be a focus on both the opportunities and barriers that currently exist. Technology should complement technological and human counterparts with reliability and high quality. When used this way, it will create a positive user experience and allow for patients, care teams, and providers to be empowered by technology and virtual care. 

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In 2009, Congress allocated millions of dollars to states to spur health information exchange (HIE) nationally by enacting the Health Information Technology and Economic Clinical Health (HITECH) Act. However, although health IT has progressed exponentially in the decade since the HITECH Act was implemented, physicians are still challenged when it comes to interoperability.

The HITECH Act included the Meaningful Use program that incentivized physicians to move from paper medical records into a digital format. The program required physicians to exchange patient information, but the bar was set low, and it was not difficult to apply exceptions. Now rebranded as Promoting Interoperability under the Centers for Medicare & Medicaid Services’ (CMS’) Quality Payment Program (QPP) authorized by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, the program continues to push physicians and providers toward interoperability. Participants are required to share patient information in order to meet measures that earn performance points, which are then applied to a total QPP score that may result in payment incentives or penalties. The 21st Century Cures Act of 2016 sets the bar even higher as it requires prompt sharing of health information with patients, other physicians, and providers upon request, with very few exceptions.

The Struggle With Interoperability

Physicians connected to an HIE are challenged by the value of the data received. A 2020 Texas Medical Association survey asked physicians if they are able to access all the data needed via an HIE when treating patients. Of the 1,303 respondents, only 17% said yes. In addition, low-value data can create extra work within the practice or be costly.

• Physicians do not always receive data sent or intended in the same or a consumable format. If the EHR cannot consume the data received, a PDF or similar attachment must be saved or information entered manually, or even worse, sometimes both. Interoperability should work seamlessly within the workflow and with such high value that it is the preferred option for sharing information.
  
  
• Information shared is not always necessary and relevant to what the medical team needs to take good care of the patient. Typically, what is necessary and relevant can be reduced to a couple of pages. However, physicians may receive hundreds of pages of information they must sift through to find what is necessary and relevant to deliver patient care. In addition to wasted time, the costs of electronically storing bloated records are significant, especially for physicians who own and operate a small practice with thin (if any) profit margins.
  
  
• Physicians in small practices do not typically have dedicated technology support. These physicians must have low-cost interoperability solutions that work well within the workflow and without a lot of extra technical effort.
  
  
• Physicians need assurances that they are sharing patient information with and among entities that embrace high standards for data privacy and security and not with weak links that risk exposing patient information. 

Because of these difficulties, many physicians continue to rely on computer-generated faxing because it fits within the practice workflow, is secure, and doesn’t require a special and expensive interface. A recent data brief from the Office of the National Coordinator (ONC) indicates that about one-third (35%) of physicians used only fax, mail, or e-fax to share patient health information with physicians and providers outside of their organization (ONC cited the National Electronic Health Record Survey, 2019).

As physicians evaluate various interoperability choices, some starting with the low-cost option of Direct Secure Messaging, which can be considered as a secure email. To send a Direct message, a physician must have a Direct protocol address and know the intended recipient’s address. Messages are sent in a secure, encrypted, HIPAA-compliant manner. CMS now requires that physicians update their National Plan and Provider Enumeration System account with a digital address, and a Direct Secure Messaging address satisfies the requirement. Unfortunately, physicians are not always well informed about how to get a Direct address and how to adjust and manage the practice workflow to accommodate sending and receiving messages. A good first step is to ask EHR vendors. A good second step is to ask the local HIE.

The Technology Is There – Let’s Use It

To spur interoperability, capabilities should be baked into the EHR so that once physicians sign the necessary user agreement(s), the spigot is activated, and bi-directional exchange happens within the workflow. By leveraging national networks and applying the United States Core Data for Interoperability (USCDI) and its accompanying standards, the developer community could help physicians exchange health information in a manner that does not require costly interfaces or a lot of technical effort. The technology does exist to accomplish HIE better, faster, and cheaper. The Trusted Exchange Framework and Common Agreement, or TEFCA, is helping standardize the rules of the HIE road. Industry efforts are coalescing in such a way that medical practices should be able to have one bi-directional connection that intelligently disseminates clinical data across the networks in a standardized way. High-value HIE allows physicians and providers to have relevant information, organized meaningfully, about the right patient at the point of care to make good clinical decisions.   

Physicians are increasingly frustrated with the inefficiencies of digitized records requiring extra time spent on technology-related challenges that take away from patient care. EHRs have always promised increased care quality, patient safety, and greater efficiency. It behooves us as health care technologists to keep those goals top of mind for better patient care, which requires working creatively and collaboratively to achieve them.

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While introducing data governance to a provider onboarding summit, I asked the question, “What do you think of when you hear the term Data Governance?”

The response… “run the other way!”

By the end of the presentation, the teams were relating to the “purpose” of data governance…

• It seeks to break down organizational barriers that lead to silos who work independently and don’t “trust” their peers from other business units as it relates to the data.
  
  
• It aims to involve the community of professionals who share common data subjects like Providers and Locations into a unified language set that allows them to understand one another.
  
  
• It introduces the potential to interoperate data between organizational boundaries when the terms used to describe that data are the same.
  
  
• It facilitates understanding of the footprint of data throughout the organization and organizes it in ways that can be understood by those who are on the front line of maintaining that data.
  
  
• It empowers the caregivers on the front line with the right tools to heal valuable data assets.

Transformation Strategy Alignment

Good Enterprise Business Architecture practices will identify an organization’s strategic objectives alongside its’ core capabilities. Where capability gaps exist, it will seek to close those gaps with process improvement efforts. Process improvement efforts invariably involve data. Therefore, to close business capability gaps, data governance fits into the strategic plan.

Transformation transformation

The prioritized list of projects for the strategic plan can be organized into a new grouping of Data Governance Subject Area’s for an organization. Health care can be organized by core subject areas (Domains) Providers, Consumers/Patients, Payers, Locations, Clinical Services, Finance, etc. The project’s focus will generally fall into one of these core domains and the critical data that needs defining can often be broken down by project. Where there are common critical data defined across multiple projects, then the unification of the definitions becomes imperative. Define once then reuse the definitions, independent upon where they are “prioritized”. A new and separate but parallel body of works begins to take formation. This is referred to as the Data Governance Working group. These working groups define the common data across organizational business areas in a collaborative setting. With projects set aside, these groups pre-define the data that becomes the scope of the future project. The beauty of the new process falls in the realization that in defining it, you have come face to face with a decision on “where” it is to be maintained. This is where interoperability begins to register among the business process stakeholders.

The core technology enablers for transformation through governance are the Glossary, Catalog, and Data Quality Platforms.

Staging the Interoperability Affect

Interoperability affects everything in an organization. When we interoperate, we serve patients according to our strengths and training. When we interoperate with data, we inform consumers according to reliable and “agreed upon” standards. Agreement does not happen in a vacuum. It is a very intentional effort that requires executive attention and focus and resolves down to the operational imperatives. This is where the Data Governance Framework comes into play. Distilling the organization that spans multiple regions and departmental boundaries can seem to be a daunting task. The discovery of the natural tendencies of leadership influence may prove to align rather well with the common data domain constructs for health care. Searching out the leadership councils that drive business priorities and shifting the lens to the data domain focus may result in reasonable outcomes.

Now that we have the organizational focus on data, we must consider some key technology enablers to accomplish this transformation. The core technology enablers for transformation through governance are the Glossary, Catalog, and Data Quality Platforms. Glossaries align business meaning to the Domain-based framework across departments and include data “classification”. Catalogs organize physical data constructs across organizational departments and can automate the classification as agreed on by the Domain authorities in the glossary. The third leg in this Governance construct is the data quality connection that extends the domain decisions regarding classification and reference data authorization and applies measures that report back to the domain authorities regarding progress toward standardization.   

Privacy Play

The technical tooling that supports data governance implementation, coupled with a renewed awareness of business processes that can be standardized to drive value and strategic alignment, now presents new opportunities to address organizational data sprawl problems. Governance artifacts deliver common business meaning to terms that tell the tools what to look for and how “sensitive” those assets are when discovered. Once the catalog tool finds the assets, which are associated to the glossary where meaning and role accountability were determined by the data governance working group, it can then report back to the data owners regarding who is consuming the data asset. This then enables the policy to apply the appropriate data treatment rule. Business processes that were duplicated around data maintenance can now reorganize with confidence and trust in the resulting operational efficiency as master data and data quality practices begin to weave into the new data fabric.

Whereas there are disparities in perception of the necessities and appropriate focus for data governance as a practice, balance around value delivery will necessitate that it be holistic in purpose and integral in the corporate strategic plan to involve the people, processes and technologies that transform organizational effectiveness.   

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It is 2025; you are on your way to a 10 am appointment with your PCP (primary care provider). You receive a text with a link to their wayfinding app which provides directions to your on-site parking space. Once you park, you receive a 2^nd text that provides access to a wayfinding application that gives you turn-by-turn directions to your provider’s office. As you walk into the building, facial recognition checks you into your appointment and a 3^rd text connects you with the ‘virtual clipboard’ where you can confirm/update your demographic, insurance and clinical information, the reason for your visit, take a photo of your insurance card and generally complete any pre-visit information while you wait. Once you have completed the pre-visit paperwork, you are directed to exam room 3, where the turn-by-turn directions get you to the exam room, where you are greeted by your doctor.

The doctor has your chart up and is reviewing your recent imaging study from the local reference imaging site, as well as the lab work done last month during your pre-employment physical. They talk with you about your blood sugar, heart rates, ECG and activity levels that were sent from your apple watch. They also remind you to refill your blood pressure medication as the information received from the pharmacy/insurance company shows that you have not refilled your medication in the last 90 days (which provides only 30-day increments).

Some would consider this an ideal encounter with their provider organization and for the future patient, interoperability and health information exchange (HIE) that delivers the right data, at the right time, for the right person, to the right person, across multiple states, systems and organizations are required for that reality. All of that exchange would be done directly, between participating organizations and their IT systems, magically behind the scenes, with no manual intervention by the patient nor the provider would be the expectation, but it’s far from today’s reality.

People suggest that healthcare interoperability falls short of other industries, for example, banking, but there is no data exchange between banks until you present your ‘card’. Banking also has the credit reporting agencies – Experian, TransUnion, and Equifax – which aggregate your financial information – which is reported directly to them by the banks – there is no such corollary in healthcare.

In today’s world – information is knowledge, power, currency, and the key to ensuring you and your loved ones get the right care, at the right time, in the right setting (without additional costs).

Health Information Exchange (the verb) has been fraught with patient identity issues. Specificity the usability, timeliness, manner of transmission, workflow integration and so on – the list of barriers exceeds the list of accomplishments on many fronts, but the foundational layer of digitized health data was brought forward by the EHR incentive program rolled out in the 2010s. This program encouraged EHR adoption amongst the provider communities, supported by technical and training resources from Regional Extension Centers and sped forward with the more recent expansion of health data exchange requirements via 21st Century Cures and TEFCA. These regulatory instruments have provided additional guardrails that are moving healthcare interoperability and standards adoption forward to reduce, remove, and eliminate a number of those barriers.

The future-forward interoperability framework will need the authority and ability to identify actors, create and deliver consent, and allow for health information to be participants in every exchange.

Still to be resolved are issues around patient, provider, and organizational identities. These are foundational components necessary to facilitate health information exchange and puts data in the right place to enable the best possible care encounter for each patient (think personalized medicine). The future-forward interoperability framework will need the authority and ability to identify actors, create and deliver consent and allow for health information to be participants in every exchange.

Organization Directory services for FHIR APIs and the like still need a home as well as a vetting authority to provide a trust framework for the consortia to be comfortable with making any exchange – patient identity with a consent mechanism that enables seamless and informed exchange also needs a home. Not to mention the need for an architecture that enables a ‘single patient identifier’ that can be shared by the patient with each of the care providers/organizations at the beginning of each encounter.

This global identifier could then be connected to the overall exchange framework and enable patient notification (and consent) of any exchanges between organizations, directly by the patient. Ideally, the industry creates that capability to enable a patient with a technology that easily supports record tracking and aggregation (think longitudinal health record) where encounters with each organization and provider are ‘logged’ with the identity of the patient and connection methodology for the organization. That ‘log’ could then be accessed by the network to connect and collect appropriate data via the supported methodology for each organization.

The future of just-in-time interoperability, where the right, correct and appropriate data arrives at the right time, in the correct system workflow for each ‘data consumer’ and it will require the implementation of trusted identity services to be in place for all participants/actors who are part of the health information exchange data fabric.

The penultimate goal is to enable a health data fabric where each ‘data consumer’ participating in the exchange gets the information needed to facilitate all clinical and administrative aspects of each encounter. That exchange should not be associated with significant costs, should happen in real-time, and enhance the quality of each individual encounter. This ultimately leads to the improved overall health of the patient and reduced costs, which so far has been the ‘Moby Dick’ of health data interoperability.

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Interoperability between health IT systems is a major challenge for hospitals and health systems today…still. In the early years of building health information exchanges (HIEs), getting healthcare organizations to participate and exchange/share data was a struggle. Adoption was poor and many were afraid of breach and the heavy government penalties, while others were afraid of losing a competitive edge. But we’ve moved on…a little.  

21st Century Cures Act says interoperability enables secure exchange of PHI (patient health information) electronically using health information from other health IT without any extra effort on user’s part; it allows for complete access, exchange, and make use of all health information available electronically; and does not constitute information blocking. So how do we evolve to meet government mandates and the spirit of information sharing? Moreover, how do we create value in improving patient safety and reducing the cost to deliver healthcare for everyone by effectively leveraging INFORMATION via interoperable health IT?

Today’s law requires that data be transmitted and written in a format that makes it possible to transfer data from one EHR system to another without a bunch of hoops for healthcare providers to SEE and understand the complete picture of a patient’s medical history. Sounds easy enough, but the struggle is STILL real. Why?? Is it because of the lack of IT? No. Essentially agreements need to be crafted to bolt on “interoperability thinking” to the way healthcare does business. Often it’s an afterthought while it needs to be at the strategic level aligned at the healthcare vendor contract level. Yes, it needs to be spelled out in HIT contracts as service level agreement (SLA) deliverables and performance measures.

According to the HIMSS (Healthcare Information and Management Systems Society), there are four levels of interoperability:

Foundational (Level 1): Establishes the inter-connectivity requirements needed for one system or application to securely communicate data to, and receive data from another

Structural (Level 2): Defines the format, syntax, and organization of data exchange, including at the data field level for interpretation

Semantic (Level 3): Provides for common underlying models and codification of the data, including the use of data elements with standardized definitions from publicly available value sets and coding vocabularies, providing shared understanding and meaning to the user

Organizational (Level 4): Includes governance, policy, social, legal, and organizational considerations to facilitate the secure, seamless and timely communication and use of data, both within and between organizations, entities, and individuals. These components enable shared consent, trust, and integrated end-user processes and workflows.

Interoperable healthcare system following the Affordable Care Act and Meaningful Use considerably aided the nation’s response to COVID-19.

The need of achieving interoperability is to give providers the most comprehensive view of a patient’s health needs to deliver safer, higher quality care that is affordable. But there are barriers to the above that includes:

•            Lack of integration…interoperability needs to be up-front at the EHR/HIT contract level

•            Disjointed health IT enforcement…compliance of interoperability needs to be internal/external

•            Incorporating interoperability standards…standardization is key and requires effective leadership

•            Challenges coordinating stakeholders across the industry…incentivize??? That sort of worked for Meaningful Use

•            Active information blocking…without a good reason penalize

Can Blockchain be a catalyst for interoperability? Though many in the healthcare industry have promoted blockchain as a solution to healthcare’s interoperability issues, its practical application is still unclear. Blockchain, the underlying technology behind bitcoin, is a distributed ledger system for tracking transactions in a highly secure system. Blockchain in healthcare would enable a provider, payer, patient or otherwise to look at a patient’s health information to know and trust each piece of data in that record. Blockchain data is designed to be read-only and can’t be edited or deleted, likely preventing fraud associated with altering a permanent record. However, differing levels of maturity when it comes to data quality and governance of healthcare organizations with low-quality data does nothing to improve interoperability. But there’s still an opportunity with Blockchain.

Consider some of the same goals of an HIE and compare nearly the same as blockchain:

•            Accuracy…Immutable and deterministic data

•            Security and privacy…cryptography and dual public/private key

•            Accessibility and transparency…decentralization, clear visibility and auditing

•            Efficiency…reduced transaction costs between agents

•            Utility…availability of digitized and structured data

•            Interoperability…harmonized between data sets

Did the COVID-19 pandemic re-start interoperability? 

Unlike previous governmental “triggers” to data sharing in healthcare, the COVID-19 pandemic drove parties to work together quickly to find data-sharing solutions. To face immediate-term problems created by COVID-19, healthcare organizations were forced to abandon administrative hurdles that hampered efficient data sharing in order to tackle those obstacles. As a result, providers and IT vendors discovered ways to improve data sharing efficiency in real time for the COVID-19 response.

Interoperable healthcare system following the Affordable Care Act and Meaningful Use considerably aided the nation’s response to COVID-19. Without the maturity of EHRs and data sharing, the pandemic response would have been crippled and more would have died. The pandemic response removed many blockers and barriers for interoperability out of necessity, as all opportunities to share data were on the table. 

COVID-19 pandemic has improved interoperability in healthcare data exchange, which may eventually help enhance the care delivery and its cost-effectiveness in the US. Throughout the COVID-19 outbreak, short-term, high-impact projects that addressed the more pressing need for efficient information flow across health providers and systems set aside larger long-term projects. Telemedicine maturity and availability alone benefitted from expanding the reach, range and time capability with time-sensitive policies and national response to technology production to assess and provide healthcare regardless of location. 

But there’s still much to do in terms of interoperability maturity and pervasiveness. We must continue to explore “above and beyond” and find ways to share data with high availability and trust so we can address health equity issues, quality, affordability of care and continuous improvement in patient safety.  Let’s not wait till the next pandemic. 

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Some of you may remember the 1982 blockbuster movie E.T. the Extra-Terrestrial, in which a young boy named Elliot finds an alien visitor from another planet stranded in his backyard. Like most kids, Elliot decides to keep E.T. and thus begins an epic adventure involving his newfound friend as they hide from government agents who want to capture and study him, to fighting for E.T.’s life as the earth’s atmosphere is slowly killing him, culminating in a daring escape via bicycle to reunite him with his home planet.  Communication is a common theme of the film and Elliott helps build a device so E.T. can “phone home.”  This is retro-interoperability at its finest – consider what Elliot used to create E.T.’s communicator: a circa 1970’s Speak & Spell!, a Sears solid-state record player, a set of Fisher-Price walkie-talkies, a UHF tuner, a lantern battery, a coffee can, a wooden hanger, and an umbrella. In the movie, it worked and allowed for this random set of combined products and systems to interoperate and successfully send a message to E.T.’s alien compatriots.  That was 40 years ago when roughly 50,000 transistors could sit on an Intel 80186 chip, whereas today’s high-end processors boast up to 50,000,000,000 transistors. With that level of technical complexity and an ever-moving target, it is no wonder that we are still seeing interoperability challenges between products and systems in healthcare today.

So why is interoperability still a challenge in healthcare? If we look at other industries – BFSI, manufacturing, retail, etc., they share a higher level of maturity for interoperability between differing systems and technologies. One could argue that the delta between healthcare and these other industries boils down to market pressures, incentives, consumer expectations and data complexity. Health systems are still figuring out that they are really in the retail business and learning to be more consumer-centric in delivering healthcare services. Many barriers to successful healthcare interop are not technical, rather business or culture roadblocks – but even these are not insurmountable. The following focus areas are a good jumping-off point for any health system looking to reach its interoperability goals.

Educate your patients on what you are doing to keep their trust as a good steward of their data.

Regulatory

The introduction of the 21^st Century Cures act regulates the currency of patient data by ensuring your data is readily available and accessible. Run afoul of this requirement and you could be reported and face penalties and labeled a data blocker.

Action Item: Ensure you are running an EHR platform that supports open and certified APIs that encourages secure access to data for third-party applications. An outdated EHR certification is inadequate and does not satisfy the new requirements of the Cures Act Final Rule.

For the vibrant application ecosystem to reach its full potential, it needs to be underpinned by the open API framework. This will support continued innovation and added functionality in the application development space. The outcomes will reduce costs, increase patient safety, and bring enhanced data understanding to patients, providers, and health systems.

Data Consistency

There is still a considerable amount of disparate data in multiple systems in most health system networks.  Much of this data is inconsistent, unstructured, and requires a significant amount of time from technology teams to search, abstract, load, transform and analyze. 

Action Item:  Create a unified network and data interface platform that will support uniformity across the various software platforms. Establishing a uniform dataset where siloed information is pulled and properly categorized is an initial step in being able to share the data. Patient portals are commonplace today, and your mileage may vary based on what data is being shared and how easily that data flows to that information hub. Consider AI and ML tools that can help in this process of getting your data house in order. 

Organization Resistance to Data Sharing

In many geographic regions, healthcare systems still run in competitive market environments. With shrinking reimbursements, alternative payment models, and shifting customer loyalty, there have been vested reasons for not sharing data with outside entities and providers. Consider big city ERs or urgent care centers where Regulation now calls for this data to be accessible and available to any organization and ultimately, the patients themselves. 

Action Item: Health systems should focus on an open model of sharing patient data that still retains security and privacy while getting the right information to the right party, in the right format, at the right time. This does require collaboration and partnering with the needed tools to execute. Adopt proper data standards, HL7 2.0, HL7 FHIR, etc. and begin the move to data liquidity and transparency.

Security & Consumer Sentiment

Privacy concerns are still a main reason why many patients do not want their health data shared. This is becoming even more relevant as consumers begin to generate their health data with mobile phones and smart wearables that collect heart rate, blood sugar levels, physical activity, and sleeping habits. Federal HIPAA laws requires that healthcare organizations and providers protect patient records, which becomes very complicated when the data points of entry are entirely outside a provider’s physical network. 

Action Item:  The new consumer healthcare solutions that use wearables and mobile phones produce a lot of data and typically don’t have as robust protections as health systems require. Ensure that your data strategy addresses where the patient-generated data is landing, how it is appropriately scanned to meet security standards, and how it is secured. HIPAA is a bare minimum; you should aim for NIST or HITRUST certifications for added protection and privacy. Educate your patients on what you are doing to keep their trust as a good steward of their data.

The promise of better-coordinated care, lower costs, and increased patient safety cannot be fully realized without seamless data exchange and access. There are many paths to reach this interoperability goal, and most will need a new organizational mindset, adoption of standards, alignment of technical capabilities and reduction in data fragmentation – with hard work and a bit of luck, we can build something that even E.T. would be proud of.

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Healthcare organizations need an explicit plan for sharing PHI that provides a foundation of trust for patients while simultaneously inspiring confidence for clinical teams. This plan meets a federal requirement and adheres to a “more is better” logic. Specifically, when patients have access to their health data as soon as it is available, it makes their lives better. This is technically challenging. The plan is often tiered with sharing of patient data at a local, regional and national level. This simple concept combines vital aspects, like access and integrity, of any good process. Most importantly, it requires bi-directional trust, which has proved to be as difficult as any technical or regulatory requirement to achieve. Trust occurs over time. It also requires revaluation over the course of a relationship. Signing a one-time consent to allow your personal data to be shared, that is legal in nature, is a form of an ongoing relationship but in and of itself, not the basis of one that on its own inspires longitudinal trust. How are the most successful healthcare organizations incorporating ongoing patient feedback and education as to how their data being shared is adding value to their healthcare journey? Do patients extend the trust they have built with their local healthcare providers to everyone else getting access to their data? Do they even understand this is occurring? Why is an educational component not linked to the mandate to share patient information? These are some of the questions we faced that need to meet these requirements or else be penalized. It is a lot to juggle.

The race to interoperability remains fast-paced and complex. Much focus remains on the how and what and perfecting compliance.

Data Sharing Vision

Understanding that visions are conceptual, the simple vision for any healthcare organization is the patient is at the center of all they do. This premise should govern all decision-making. In everything done, the intent is to make patients’ lives better. However, for this to be successful, there must be a clear understanding and ongoing process for patient feedback. Part of any vision is the messaging component. Data sharing is very technical in nature and hard to message at the concept level. Internally, this has been a struggle to accurately educate leaders on the concepts and talking points. Sometimes, because of this complexity, not much messaging and/or education has occurred. Also, many organizations have emphasized the technical proficiency of meeting all data sharing requirements first. Understanding how or if this is making their patients lives better has been addressed secondarily or not at all. Many organizations have a Patient Experience office. In the race to share with a patient as much of their health information as possible, this office has felt the pain and frustration of patients that are confused and upset. The lack of messaging and education to internal staff make these conversations with patients awkward and frustrating. Instead of helping, it escalates their concerns. Trust is affected.

Patient Rights and Patient Education

What do we want to teach and help our patients better understand? How is access to their patient data helping their healthcare journey? These are difficult questions to answer at a granular level. For example, one area of complexity is that we don’t have a unique patient identifier. This has been codified in federal law. We’re not allowed to have a unique patient identifier across the US. What we have is called a master patient index (MPI). And in that MPI, someone assigned an MPI number to you, which is unique, but specific to this system. It does not translate to other systems within a healthcare organization and it is not easily shared with outside organizations unless they use that same system. The local or state HIE that exist try to do the best job possible, but again, there is no global identifier to give an overall picture of what care looks like based on movement around the US. This is very confusing to patients and even to some providers. They have been told their personal information is being shared, but their provider says they do not have access to it. They then, of course, want to know who is seeing their info without their knowledge. These are the calls fielded daily by physician offices, EDs, or anyone patients think can answer the question of “why is this not working for me”? Trust feels broken. Depending on your setting and patient population, there is an innate fear and distrust of technology. Also, in some cultures, talking to the doctor is a social event. Patients receive rides, perhaps a meal and a chance to interact with others when they may live more isolated. They want and need personal interaction as it provides comfort they don’t understand well. This has to be considered and programmed for as well. In this example, we should be asking “if this enhances of patient’s lives” more often and then mapping that back to how we educate and then respect their rights. Sometimes, they may not feel a government mandate is in their best interest. How is that being addressed at the macro level?

Internal Ownership/ Governance/Controls

Mandates in healthcare get the attention of senior leaders. They too can find dollars for internal investments to meet the mandate. Cross-functional groups are convened quickly and easily at first and plans are crafted to become compliant. Rarely does the planning of how to meet the mandate include long-term understanding and investment of people, processes and systems. Fiscal penalties are strong motivators but often do not drive long-term revenue growth. Once an organization becomes compliant, interest wanes. The transition to support is just expected. But in solving this mandate, you have created yet another program that needs ongoing leadership, tuning, funding, monitoring and surveillance. Organizations then see this as a burden instead of optimizing how it can add value to their patient’s lives. 

The race to interoperability remains fast-paced and complex. Much of the focus remains on the how and what and perfecting compliance. Much more of the discussion needs to occur on how this adds value for our patients, how are their rights being considered (other than HIPPA compliance) and how organizations build the infrastructure needed to support them ongoing. As trusted advisors, data sharing and its value should be much easier to understand and explain to all involved with tangible and measurable results of reliable improvements. It is a fantastic problem to solve. 

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