21st century cures, 20th century fears

By a resounding bipartisan vote, the House recently approved legislation authorizing an $8.75 billion dollar Innovation Fund under the National Institutes of Health, designed to capitalize on recent breakthroughs in our understanding of the human genome —essentially, the software that makes life tick.  

The 21^st Century Cures Act responds in part to President Obama’s earlier call for a Precision Medicine Initiative. One day this bill may be regarded a crowning achievement. That is, if Congress also revamps our antiquated medical privacy laws and upgrades our technological capabilities. 

{mosads}In a new white paper, we call on Congress to systematically review the costs and benefits of privacy laws in light of recent scientific and technical advances. There are less burdensome models for protecting privacy- we use them every day. And while cyber-security is a growing concern across all sectors of society, it is safe to say that your knee scan or Lipitor prescription are of less interest to hackers than the current law presumes. 

Thanks to the 1996 Health Insurance Portability and Protection Act (HIPAA) and its 2001 implementing regulations, the medical industry has become our home-grown version of Cuba, insulated from the rest of the world in ways that make it the least consumer-friendly and most wasteful sector of our economy.  

Enforced by a punitive regime of fines and jail terms, HIPAA elevates even the most mundane health records to the level of national security secrets.  

Last year, the HHS fined New York-Presbyterian Hospital and Columbia University $4.8 million when an employee inadvertently made 6,800 records publicly available containing data on patient status, vital signs, medications, and laboratory results. Such penalties are not meant to reflect actual harms but are based, mechanically, on the number of records involved. That approach may have seemed reasonable in 1996, when Apple was little more than a niche computer maker.   

That smart phone in your pocket is packed full of apps that track your location, purchases and browsing — each with your express permission. Although medicine is the one area of your life considered to be of utmost importance, it is also the one where connectivity is not fully utilized.  

The Institute of Medicine estimates that one-quarter of health spending is squandered on unnecessary care, neglect and mistakes. That’s more than $6,000 this year alone for a family of four. Rooting out such waste requires better access to patient data, which often cannot be reviewed because it is tightly locked away in the name of privacy. As the uses of data grow, so, too, do opportunity costs of its compartmentalization. 

Converging advances in a range of supporting technologies — from genetic sequencing to optical super-resolution fluorescence microscopy — are raising the prospect that we may see during our lifetime cures for scourges like Alzheimer’s and type-2 diabetes along with the 95 percent of rare diseases which today are largely untreatable. Predictably, this has set off an international race for cures. 

It was against the backdrop — and in particular, the dramatic research push by China —that Obama used his 2015 State of the Union address to call for a national project to sequence one million genomes. Yet even with the new funding provided by the 21^st Century Cures Act, U.S. research productivity will remain dismally low if Congress does not modernize privacy law. 

With some three billion chemical “letters,” each human genome is a massive repository of personal information — the equivalent of 100 high definition movies — where even the order of genes and proteins can have dramatic physical outcomes. The complex picture that is emerging suggests that genomes from a great many individuals must be mapped, catalogued and compared before the full extent of human variation comes into focus.  

But that is only the first step. Interpreting the physiological role of genetic variations requires correlating each patient’s genome their health records. Unless this astoundingly large trove of genomic and health data can be shared among hundreds of institutions and thousands of researchers, progress will come too slowly to maintain America’s lead in this defining technology, or to aid the many millions of patients who today are living on the edge of hope. 

So we need interoperability standards to share information before the project starts in earnest.  A new consent process that is computable and that reflects granular preferences is necessary. And patient engagement should be more than words, but incentives that reflect the value of participation, like discounts on premiums and reimbursement for child care and transportation costs.  

Now dangerously retrograde, health information policy is badly in need of updating, lest 21^st century cures fall victim to 20^th century fears.

White is the executive director of the Health IT Now Coalition, a diverse group of organizations working to help integrate information technology into healthcare.