The Washington Post recently chronicled the horrendous story of a woman whose positive mammogram result was inadvertently forwarded to the wrong doctor. The woman didn’t learn about the test result until a year later, when she proactively asked for the report; today, she’s living with the aftermath of a mastectomy—and wondering if prompt delivery of her test result for breast cancer would have led to a better outcome.
The prospect that a positive test report for a dreadful disease like cancer could be delayed by a year will keep any physician awake at night. But the story highlights more than the damage that can happen to a patient when results are not delivered in a timely fashion. It also underscores the failure of the medical and legal systems to ensure that patients are empowered to directly access their own test data.
In the United States, patient access to health data, as regulated under the Clinical Laboratory Improvement Amendments (CLIA) and Health Insurance Portability and Accountability Act (HIPAA), ultimately depends on the laws and regulations of the state where a patient resides. Some states permit patients to access some or all test results upon request, while others require physician consent to deliver the results to the patient. Still other states have no laws or regulations on patient laboratory-data rights.
Many of the states that do not permit direct patient access are also among the most densely populated. As a result, about half the population of the United States lacks direct access to its own test results from laboratories.
Fortunately, this situation may soon end. On September 14, 2011, the Department of Health and Human Services (HHS), in conjunction with the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights, proposed rules to give patients access to their data from laboratories. If adopted as written, the new rules will ensure that labs covered by HIPAA provide results, upon request, to patients or their personal representatives, either via printed or electronic media.
HHS Secretary Kathleen Sebelius, in explaining the basis for the proposal, asserted that “information is power” and noted that “when patients have their lab results, they are more likely to ask the right questions, make better decisions, and receive better care.” The proposal will not be finalized and adopted until CMS reviews public comments and publishes final rules, likely in late 2012.
Not everyone is convinced that direct patient access to lab data is a good thing. Some physicians argue they do not have time to counsel patients who (they expect) will seek to clarify results that are not a health concern. Others fear that direct access may provoke confusion and anxiety in patients rather than improve dialogue and decision making with physicians. A recent commentary in JAMA notes that while patients generally indicate they want direct access to their data from laboratories—and indeed, a sizeable percentage of positive test results provided to the ordering physician by the laboratory may never make their way to patients, according to some studies—little research has been done on the impact of direct patient-data access on physician offices, patient psyches, and an overburdened healthcare system.1
These are valid concerns and require additional consideration. The final rules, once adopted, should incorporate measures that maintain the medical consultation’s primary role as the foundation of clinical integration and test result interpretation and delivery. For instance, providing the option to extend the HIPAA Privacy Rule, which affords covered labs a 30-day window to fulfill an individual’s request for private health information, will give physicians needed time to review and interpret sensitive results for tests that require several days or weeks to run.
However, well-intentioned efforts to maintain the physician’s vital role in healthcare service delivery should not confuse the central issue: ensuring patients can exercise their rights to access their test results. Limiting patients’ access to their data necessarily denigrates patients’ sense of responsibility and engagement in their own healthcare. We all recognize that greater patient engagement is necessary to promoting better outcomes and lower costs. Having patients take greater responsibility for their health by giving them direct access to their data from laboratories is a crucial step to meaningful reform.
Direct patient access has other far-reaching consequences. For years, the adoption of health information technologies, including medical and patient records, has moved at glacial speed as physicians, hospitals, and health systems have struggled to use these technologies to improve, rather than derail, workflows. While recent government financial incentives have spurred greater use, many facilities still rely on pen and paper to create records.
The confluence of direct patient rights, the Internet, and mobile devices will spur increased adoption of information technologies for managing health data. We’re already seeing mobile technologies drive greater demand: within weeks of its launch, several thousand physicians downloaded Quest Diagnostic’s Care360 mobile app for delivery of lab results. Demand for Quest’s Gazelle mobile health app for patients has also grown robustly since its introduction about a year ago. It is instructive that Gazelle users (living in states where direct patient access is allowed, of course) tell us they love the tool because it gives them control over personal data they otherwise could not easily access.
Technology-empowered data access that enhances patient engagement with their physicians will reinforce the value of laboratory testing and the physician’s role as the primary steward of healthcare decision making.
Jon R. Cohen, MD, is Senior Vice President and Chief Medical Officer for New Jersey-based Quest Diagnostics. Dr. Cohen also oversees the company’s hospital services business.
References
- Giardina TD, Singh H. Should patients get direct access to their laboratory test results? JAMA. Published online November 28, 2011.
