Ensuring Portability and Patient Ownership of Health Data: The Great Potential of ONC's Proposed Interoperability Rules

Healthcare has incredible diagnostic imaging technologies, from CT scans to 3D heart MRIs, which make it possible to diagnose and treat disease states that used to be undetectable. Unfortunately, these images have historically only been accessible through siloed imaging informatics systems that are unintuitive, unhelpful and non-interoperable. In the past, these meticulously acquired images were often highly inaccessible at the point of care and have been incredibly challenging to integrate usefully with other clinical data. This is, thankfully, no longer the case.

The ONC Proposed Rule on Promoting Interoperability provides an opportunity to take advantage of technological advances that now routinely facilitate the incorporation of diagnostic imaging into a wide variety of data systems, eliminate obsolete processes such as transporting imagery via CD and ensure full patient access to medical records.

Why Change Is Necessary and Long Overdue

There are several reasons why diagnostic images have not become part of the patient record demanded by previous federal rules. Some of the most prevalent include reluctance of large market incumbents to change their ways of doing business to allow for greater flexibility in data access; resistance by industry to make investments in standards-based technology to facilitate interoperability; and perceived technical challenges in managing unstructured data. Vendors want to defend their market shares, hospital systems want to minimize referral leakage, and few parties want to invest in interoperability unless it is directly tied to revenue. The incentives in place in today’s healthcare system encourage vendors and providers to retain data and maintain barriers to interoperability.

Forces from outside of this walled healthcare garden, however, are quickly making this system of siloed data untenable, including ambitious tech giants with powerful data platforms, patients advocating more vocally, and the federal government demanding changes.

The industry must prepare for this increasing demand for a truly interoperable and interconnected system. In order to achieve a workable system for storing, managing and distributing diagnostic images (one of the most essential parts of healthcare data), the following things must change.

Federal Requirements for Data Sharing

Pretty much everything aside from healthcare data has been transformed by the digital revolution of the past couple of decades. This transformation has resulted in new levels of consumer demand for data transparency, access and usefulness. Healthcare providers and industry vendors have largely insulated themselves from consumer demand and other market forces through the current structures imposed by a third-party reimbursement structure, heavy regulation and reinforcement of existing clinical workflows.

Since external forces that would compel market participants to eliminate data blocking and enable full interoperability are muted more in the healthcare market than in virtually all other markets, the federal government is now mandating that the healthcare industry adapt and begin to address consumer needs for data, access and portability.

The Essential Diagnostic Image

Including diagnostic images as a required element of a patient’s medical records is essential for driving the positive impact of the new federal requirements. Imaging data is one of the most critical and important clinical end points for many therapies. Cancer is the most obvious, but multiple sclerosis, ophthalmology and a host of other conditions require diagnostic imaging both to provide a fuller understanding of the disease state and to effectively communicate that understanding to other physicians and the patients themselves.

The first generation of electronic health records (EHRs) focused on reimbursement and led the way for how certain types of healthcare data would be organized and standardized. Diagnostic images were handled by picture archiving and communication systems (PACS). A decade ago, the infrastructure and interface challenges were significant enough that incorporating diagnostic images in medical records was delayed. The early work of regulation built an essential foundation, which now needs to be improved and brought into line with current technologies.

Since the days of early regulation, technology has improved immensely. Digital Imaging and Communications in Medicine (DICOM) images can now be distributed and displayed in a variety of standard ways outside of their originating PACS and by an ever-increasing array of applications. Without going into the technical details, objections to incorporating diagnostic images based on cost or complexity result from an obsolete understanding of what is possible.

Improving Technology and the Elimination of CDs in Clinical Image Transfer

CDs have vanished from most of civilian life (and so have faxes, which continue to be used across the healthcare system), but radiology still relies on them heavily. Just as the industry once converted from film to CDs, now it is time to convert from CDs to direct PACS to achieve full connectivity.

Right now, patients often serve as messengers, bringing CDs with their diagnostic images from one facility to another — even though they struggle to access those same images as part of their medical record.

Once the patient and CD are at the treating facility, ingestion of the data on the CD is slow and often delays clinical care. Important parts of data sent on CDs are often unreadable — whether due to someone neglecting to remove a password or scribbling a notation on the disk’s readable side, making it illegible. Differing standards or clinical workflows also typically mean a lengthy conversion to get the data into the system of a treating or referral provider. The number of hurdles to a smooth transfer of diagnostic images seems almost infinite.

CDs have been incorporated into workflow, and this system works, if badly. So, there could be a bit of hesitation in switching to something new, but this hesitation has gone on for the better part of a decade.

The new regulation should incentivize the switch and make it possible for everyone to access diagnostic images without CDs. This will minimize the amount of time providers need to manage multiple systems and ensure that the smooth flow of information continues between providers, payers and patients.

Why Healthcare Needs a Wide Definition of Clinical Images as EHI

Medical images have grown in importance over the past few years and will continue to advance in science, forming a key part of the diagnostic record. This definition must include a variety of non-textual data formats, including EKGs, peripheral blood smears, skin lesion images, retinal scans and many others.

New imaging types and uses will continue to become part of standard therapeutic practice. Imaging manufacturers are increasing the varieties of 3D imaging and adding nuclear and hybrid imaging, intra-operative technologies and portable imaging devices. New ways of automating the interpretation of diagnostic images through artificial intelligence (AI) and machine learning will transform how these images are used. If the definition of electronic health information (EHI) is not broad enough, these new approaches will be handicapped.

There are specific meta-tags that should also be defined as mandatory for all diagnostic images. A number of other meta-tags, particularly those related to internal processing, should be excluded.

Most important, it should be a requirement that any associated radiology report be attached to the image in order to provide essential clinical context. Without this context, the image is of less use. This must become the standard.

Improving Patient Access to Medical Records

The difficulty, time delay and expense patients often have to go through to access their own medical records is appalling. Institutions often have internal policies that create barriers to access, including onerous forms and high fees. This is not the result of obsolete technology, as with CDs, but simply from the retention of obsolete business practices.

Such records should be provided within a defined time limit and include diagnostic imagery with associated narrative. The time limit should be negotiated, but the industry should establish reasonable goals that provide patients with their information within a reasonable time without overly burdening the providing health system.

How to Best Manage the Inevitable Changes

These changes are coming. Diagnostic images will be part of medical records. They will be easily viewed and manipulated. They will be transferred easily and effectively. They will continue to grow and evolve over time, incorporating more and more information. Patients will have access to them, along with the rest of their medical records. This is not a technical challenge; those barriers have been solved by industry.

Changes are coming, but when they get here and how disruptive they will be depend on how they are managed.

And that is up to us.

Matthew Michela is president and CEO for Life Image.

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