In passing the 21st Century Cures Act, Congress took bold steps toward more effective and precise treatments for a wide range of conditions. The act authorizes billions of dollars for medical research and is intended to speed up innovation in treatment discovery and delivery.
Tacked on near the end of the process was an amendment that may prove to be every bit as valuable to medical research as the act’s nearly $8 billion in funding. It directs HHS and the Office of the National Director for health information technology to make EHRs interoperable and facilitate the flow of information.
Healthcare providers have been gathering and storing electronic health data for the past decade at an astounding rate. We have an enormous amount of potential knowledge just waiting to be tapped. But because of a variety of barriers, that data has largely gone unused. It’s sitting there in data centers, but we just can’t get to it. Much of the original promise of EHRs has been lost because of the barriers to a free flow of information.
That late-arriving amendment to the Cures Act is intended to tear down the barriers. It sets forth criteria for systems to be considered interoperable, requiring:
- Secure transfer of the entirety of a patient’s data from any and all health information technology.
- Access to the entirety of a patient’s available data for authorized use without special effort
- Configuration of technology so that there is no information blocking
The act also sets out five categories for interoperability standards, including
- Vocabulary and terminology
- Content and structure
- Transport of information
- Security
- Service standards.
These basic requirements and standards should have been put in place a decade ago, when the big push toward EHR adoption began. So it is welcome news that Congress is acting to increase interoperability now. These new standards will help open up the spigot to allow the flow of information in some very important ways.
Better patient data for better medical decision-making
The first way the free flow of data will help is in making it far easier for clinicians to gain a complete view of a patient’s medical record. This should help reduce medication conflicts, over medication and redundant testing, and provide more complete data for decision-making. Too often, critical data doesn’t show up at the point of care, leading to missed diagnoses, wrong diagnoses or inappropriate or unnecessary treatment. Better, more accessible contextual information will be a big step forward for individual patients and their physicians. It should also help hold down the cost of care.
Guiding researchers in the right direction
But the implications for improved data flow are far broader than individual patient care. Access to millions of de-identified patient records can be a gold mine of information for researchers, providing data on treatment effectiveness and helping us connect the dots on the complex causes of disease. Combined with genetic data, this enormous trove of patient histories can help us better understand how and why diseases occur and why some patients respond to a medication and others don’t. That will allow us to quickly and more precisely match patients and treatments, which will save time, money and suffering. It will also speed up the research into new treatments.
Cancer is a good example of how data, genomics and analytics are rapidly increasing our knowledge and effectiveness. With the advent of genomics, we now understand that knowing the site where the cancer first occurs, such as the breast or the liver, is far less important to treatment than knowing the underlying genetic mutation that allows the cancer to flourish. This makes possible new treatments targeted at the mutation and its impact on the patient’s physiology. It means that we are beginning to move away from the big sledgehammer of chemotherapy to more precise, effective and less destructive treatments that use this knowledge.
We have enormous volumes of patient clinical data, and we need to combine that data with genetic sequencing to better understand the physiological processes in play in all kinds of diseases. That will allow us to design more effective treatments.
In many ways, greater interoperability of clinical data systems will be a powerful foundation for all the other aspirational goals in the rest of the Cures Act. Access to data, combined with analytics, can help guide researchers to ask the right questions and investigate the most fruitful areas first. It’s like the difference between searching for something in the dark without your glasses and making that search in broad daylight with the right corrective lenses. Groping in the dark is better than doing nothing, but if you can shine a light on the subject you will find what you’re looking for much faster and with less cost.
Big pharma and clinical trials
The days of large cohort, double-blind placebo-controlled studies for testing new drugs and devices are beginning to wane. These large clinical trials are expensive and time-consuming, adding hugely to the time and cost of development. If you are creating the next blockbuster drug, a big clinical trial makes sense. But as we learn the nuances of disease, we’ll need a wider variety of drugs options targeted to the individual physiology of the patient. The big blockbusters will go the way of the dinosaurs. That means we need a faster, less expensive way to find and test new drugs and other treatments. Access to all clinical data (not just big data sets but ALL data sets) combined with analytics will help researchers find the underlying physiological pathways of disease and design treatments that correct the flaws or inhibit the adverse consequences.
Some critics of the Cures Act believe that loosening of FDA oversight of drug and device development will put the public at risk. They could be right, because there are numerous instances of drugs and devices that reached the market with serious flaws, despite testing and oversight. Reducing that oversight could mean greater risk to patients. But along with the loosening of FDA oversight comes increased oversight from the scientific community, clinicians and patients, all empowered with easy and complete access to the data. And better access to real-world data may help researchers find better treatments faster, reducing patients’ exposure to imprecisely targeted treatments and accelerating universal access to cost-effective precision medicine for everyone.