Should the patient have certain alienable rights with respect to the governance and controls of his health information? Absolutely. Are there certain things a patient shouldn’t be able to do that you would normally think of as an owner’s right? Yes. Most people would agree that a patient should not have the ability to remove important medical information from his history. So the question of who “owns” the data may not be the exact question we need to ask. What’s at stake more than anything else is the question of whether the patient should be able to control who has access to that information and who does not.
As the healthcare system becomes more and more patient centric, the patient will necessarily have markedly more influence over his health data. It is my personal belief that the patient should be in control of who sees his data and over how it is used. This is particularly true of genomic data in which it not only uniquely identifies the person, but conveys information about that person’s family members. But we have to recognize that people will want to have different levels of discretion over decisions about who should have access to this data. Some people will not have the capabilities or desire to make such decisions, and for them a default level of access can be set. Others will want to review use of their information on a case-by-case basis and decide how their information is used.
The question of whether or not a research entity should notify patients of health-related information discovered during research on donated samples brings up issues that have no precedent in health care. Again, the key principle is that there should be no one-size-fits-all, so patients need to decide this differently for themselves. The key to this is a new approach to the informed consent process. Today’s informed consent has become a perfunctory activity, aimed at risk reduction as opposed to presenting patients with options and choices. I am a proponent of an opt-in/opt-out system in which we present options to the patient in advance, e.g., do you want to donate your sample without restriction; do you want to know what’s discovered from research on your sample; do you want this information reported to others. It is the patient who will bear the consequences of the decisions, so let’s allow them to decide. This may be a barrier to good science, but we can’t harm public good in one area in order to create public good elsewhere.
Information technology will be a key enabler in making the consent process more responsive and customized, making it possible to keep track of which tissue is from which patient, what information that patient wants back, and who can have access to that information. It’s my belief that if UPS can keep track of millions of packages in real time at every point in transit, we can keep track of a patient’s sample, and his consent decisions that are associated with it.
Addressing how we let consumers decide how far they can go in managing access to their health information challenges current policy. Current policies tend to be based on an era that was dominated by paper. We have not adapted these policies to align with the digital era of medicine. HIPAA and some of the state laws provide a basic framework, but we need to recognize that the world has changed – what used to be adequate has now become incomplete in the digital era. One group that I established as National Coordinator, the Health Information Security and Privacy Collaboration (HISPC), is looking at privacy and security issues related to electronic health information exchange and the creation of a national health information network. In the coming weeks, they will be releasing findings of a two-year investigation between federal government and 43 states looking at their privacy rules.
As the healthcare field becomes “networked” in this post-genomic age, health information will be generated and distributed at an increasingly fast pace. The health record won’t be a database, but a streaming set of life situations, exposures, metabolic responses, preventions and treatments. One key area that we need to focus on is the importance of bringing the physician into the loop. Our vast and impressive scientific discoveries don’t matter if they aren’t known by or useful to physicians in practice – not only about what discoveries are taking place, but more importantly, how these discoveries translate to what a physician should do differently. We know how to prevent and cure numerous illnesses and mitigate many others. We just don’t know how to translate this into real health status for the American population.
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