In 2000, usability expert Steve Krug published what became a best practice book about web design, Don’t Make Me Think – A Commonsense Approach to Web Design. Krug’s basic design premise is this. If your Web design forces a visitor to “think”, (functionally), you’ve lost them. As he says, “It’s not about technology…while technology often changes quickly, people change very slowly.”
That same basic design principle is ready to be applied to the subject of personal health information consent. The majority of healthcare consumers allocate very little time to thinking about their health. Managing their health data falls even lower on the average consumers’ radar. When confronted with a HIPAA release form at the doctor’s office or emergency room, “where do I sign and what box should I check” are likely to be the health care consumer’s most automatic responses.
Instead of requiring patients to fill out tedious, redundant forms with opt in/opt out provisions they largely pencil whip just to get through, why not shift their limited attention span to making meaningful/timely decisions regarding the use of their health data? If we can agree that meaningful interactions are a desired outcome, then we can agree that Meaningful Consent is our path forward.
Meaningful consent occurs when a patient makes informed choices about his or her health care preferences, and those choices are properly recorded, protected and maintained.
The ONC describes a meaningful consent decision as having six aspects:
- It is made with full transparency and education;
- It is made only after the patient has had sufficient time to review educational material;
- It is commensurate with circumstances for why health information is exchanged (i.e., the further the information-sharing strays from a reasonable patient expectation, the more time and education is required for the patient before he or she makes a decision);
- It is not used for discriminatory purposes or as a condition for receiving medical treatment;
- It is consistent with patient expectations; and
- It is revocable at any time.
Although this definition is helpful, operationalizing it becomes problematic given the nature of the industry and consumers interactions with it. For example, a patient with a care team consisting of a PCP, two specialists, receiving care for a chronic condition through one health system, having an emergency department encounter at another, enrolled in their employer’s health management program, participating in a clinical trial, and just relocated by their employer from Boston to Austin. Where does the consent reside? Does the patient go back to every point of care and revoke prior consent? Are the meaningful consent methodologies consistent across providers? Is the burden on the patient to adapt to each provider’s approach? How does the consumer track where and who they’ve authorized to access their data?
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
This self-created Gordian knot takes the meaningfulness out of the consent conversation, replacing it with red tape, paperwork and the appearance that health care management is trapped in a pre digital- era time warp.
We can transcend these obvious issues that everyone acknowledges need to be addressed and achieve a “don’t make me think” design construct today. The first step is to agree to these principles:
- Consent should be transaction based, e.g. — when the consumer takes an action it triggers a consent decision — visits a specialist, establishes a new physician relationship, purchases a data-enabled mobile app, etc.;
- The methodology for authorizing/revoking consent should be universal;
- A record of consent grants and status should be easily available;
- Authorization should be “partitionable.”
Getting people to proactively manage their health is challenging enough. Consumers need tools, resources and infrastructure that enable them to succeed. If healthcare is to truly be consumer centric, then “don’t make me think” must become an industry user experience standard.
Photo: Free Digital Photos
