Will Healthcare See Ethical Patient Data Exchange?

The last day for public comments on the proposed Centers for Medicare & Medicaid Services (CMS) interoperability rule has passed. But moving beyond proposed rules, questions about ethical data exchange and financial responsibility remain.

When we addressed the proposed CMS rule, people have asked if this is an artificial measure that will strengthen an already failing health information exchange system when these organizations have not had sustainable business models in the past. More important, will this rule align Medicaid with a mission that will improve the health of the poor? Should patients with complex care needs and social disadvantage be held accountable for coordinating the data exchange for their care? Also, have the proposed regulations allowed for patient control of their data sharing?

Personal data access can lead to different care, and the question remains whether that will mean discrimination against patients in an at-risk group. This can include diagnoses that providers have discriminated against, such as AIDS or borderline personality disorder, or information that would mean a patient cannot afford care. If you know your patient will not heal, what is the best way to proceed with a given surgery?

The proposed CMS rule, as currently written, excludes much of the safety-net patient population.

“Like it or not, the emergency department is often the front door of a health system, and many safety-net patients understandably rely on it for their care,” says Chris Klomp, CEO of Collective Medical, provider of a real-time care coordination platform focused on collaboration for vulnerable and complex patients across the country.

The company analyzed encounters in its network and found that 93% of patients with more than 100 ED visits over the prior 12 months had a behavioral health diagnosis. Further, Collective Medical’s analysis of ED encounter data from hospitals across its network revealed that patients with more than 10 ED visits in the prior 12 months have, on average, more than eight chronic conditions.

“These statistics underscore the complex needs of the underserved, highly vulnerable population that frequents EDs across the country — locations staffed by providers well positioned to instantiate a broader set of clinical care pathways to help these individuals longer term — and provide compelling policy rationale for including ED visits in the CoP ADT feed requirement,” Klomp adds.

Patient-Centered Interoperability?

Are we creating better patient access through the CMS proposed rule?

We're less than a week away from the comment period deadline for our proposed interoperability rule - developed to help break down barriers and give patients easier access to their medical records! Be sure to submit your comments & insight today: https://t.co/bP5bfyd6eB

— Administrator Seema Verma (@SeemaCMS) May 29, 2019

I spoke with Teresa Rivera, head of the Utah Health Information Network (UHIN), about the proposed rules and the importance of patient data access.

UHIN emphatically agrees that patients should have access to their claims history and clinical encounter data. This is one method to ensure that the data follow the patient regardless of where they are in the healthcare continuum. The patient is an important stakeholder in the interoperability paradigm, and they, along with their appointed caregivers, should have secure access to all their healthcare data.

Health information exchanges’ dedication to patient care is key to their role in facilitating information sharing. Does this rule improve patient access or shift the burden to patients? One of the most important parts of patient control is allowing patients to have access to who sees their health information.

As health policy attorney Erin Gilmer points out in her writings, there are no patient portals into health information exchanges to allow patients to selectively restrict access.

“Interoperability is great until you realize that the patient has no control,” Gilmer writes. “No control (over) what is in their chart. No control over how and with whom it’s shared. No control to get out. No control to stop the flow of information they trusted to be held in secret.”

Human error accounts for many data breaches, and patients should have technology that enables them to protect their data.

The proposed CMS rule about interoperability was not intended to give a health information exchange undue business strength, just as these organizations were not intended to create an asset that does not serve patient care. Historically, many health information exchanges were funded through the HITECH Act, with the idea that they would become financially self-sustaining after the initial investment. Susan Matney, Ph.D., points out the importance of data access for improved patient care. This becomes clear, for instance, when patients must be contacted immediately. “We have had medications that they pulled off the market instantly because they had physical problems. Because they were coded in the data dictionary. we could go out and find everyone that was using that project.”

Accessing patient data for patient safety concerns such as in this example means having data access when it is needed. But the clear cases of when patient safety should override patient data sharing preferences must be defined. Who can access which information and for what purpose is not clear enough with new guidelines for incorporating social determinant data. It is also not clear enough for patient-directed data interoperability. Is an emergency room visit a patient data security emergency when physicians should know health history, even if a patient does not want that data shared? The answer is: It depends. In some cases, it makes a difference, such as when a pregnant woman is in a car crash and might have a pre-existing condition. In other cases, like when a patient with reasons to believe they are not receiving the best care from their primary care physician, data should not be exchanged.

Social Determinants of Health

The social determinants of health discussed in the proposed CMS rule consists of a specific set of data that are relevant to health outcomes. That includes factors such as housing and the conditions that patients live in. When a patient does not have a home, they stand little chance to recover. When they have mold in their home, they will likely have ongoing respiratory problems. Knowing more about the outside support group can lead to connections with social services and more help for patients. While the proposed CMS rule suggests including this data, it may not account for patient data needs created by social determinants of health.

Understanding specific and relevant data becomes even more complicated when addressing public health data such as social determinants of health. As UHIN’s Rivera says, the standards that we need in order to have great data standards surrounding social determinants of health are lacking.

“UHIN fully supports the development of future models, including piloting emerging standards that identify social determinants of health. We are convening our community to share such data and have discovered that standards are lacking,” she notes. “We need to ensure that the data is standardized to move with the patient through disparate EHRs and systems used by various social service agencies. The need includes allowing data to move to social service programs such as 211, Meals on Wheels, transportation services and homeless and housing programs. The standards must allow for referrals to be made between the health and social service programs with closed-loop information back to the referring entity.”

Health Information Exchange

Every state has different strengths. Patients do not have an equal experience with their health data across the United States. This raises the question of how the proposed CMS rule will impact patients and existing companies. In terms of health data, it is popular to notice things are not working as intended and using policy or regulations to force changes. But it is not entirely clear that the changes will be effective in solving the problems. Even effective health information exchanges don’t know what the interpretation of the proposed rules will mean.

“From our perspective as a regional health information exchange, we support reasonable regulatory oversight that keeps bad actors in check and encourages the sharing of health information,” notes Doug Dietzman, CEO of Michigan-based health information exchange Great Lakes Health Connect. “Our concern as to the proposed rule is how the term ‘data blocking’ is defined and applied. An organization can only block data if it is the originator and sole source of the data.

Dietzman says his organization has developed a “unique asset” that provides value for the state’s healthcare stakeholders by “importing a copy of their raw data, then normalizing, aggregating, formatting and delivering it when and where it’s needed.”

That makes the information-block question tricky. Our unique asset is what we’ve done with the data to make it more valuable, not the data itself,” Dietzman adds, “and as a business associate, we have limitations on what our covered entities have said we can do with their data. GLHC requiring membership and payment for access to this unique asset within its business model does nothing to block access to the patient’s data collected and made available otherwise by its covered entities.”

But Great Lakes Health Connect leaders worry that proposed regulations could compel the health information exchange to provide that asset, free of charge, or end up in hot water. Dietzman says he supports greater patient data access — but data-blocking rules could ultimately “impede the very exchange networks that are working hard every day to make this happen.”

Great Lakes Health Connect has created a great ecosystem where data can be exchanged, adding value to physicians. The balance between public health data, patient data and government and private entities is fraught with ethical and practical considerations. Who is responsible for empowering patient-centered data exchange and the impact of exchange cannot be fully understood yet?

Responsible Data Exchange

Who should bear the cost of patient data exchange? It is an ongoing question with health information exchange and the proposed interoperability rules. How they might impact patient-empowered data exchange and whether data exchange systems will protect patients remain to be seen.

Facilitating better access to social service programs is something that a great health information exchange should do to enable healing. Patient-led data sharing is not adequately addressed in the proposed CMS rule, and bias in care needs to be carefully addressed, especially for rules designed in the care of populations that have less access to financial means.

Patient access to and control of data is one of the most important things we need to address more completely through any proposed interoperability rule.

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CMS, ONC Rules & the Information Technology Foundation of Healthcare Progress