By Kerry Young, CQ HealthBeat Associate Editor
June 25, 2014 -- Silicon Valley entrepreneur Anne Wojcicki had to halt sales of her company's genetic tests for medical uses last year after the Food and Drug Administration voiced concerns over how the data would be used and its accuracy.
That experience hasn't soured Wojcicki's outlook on the role that the government may play going forward in transforming a growing wealth of data into practical tools for improving the health of Americans. In fact, in a Tuesday interview, she was enthusiastic about the steps that officials within the Department of Health and Human Services (HHS) are taking to make personal health information and broader health trends accessible.
"They get it. They get the fact that it is critical to unlock data and empower consumers," said Wojcicki, who spent a decade in the field of healthcare investing before founding Mountain View, California-based 23andme in 2006. "That the government now is focused on unlocking data is transformative."
House Energy and Commerce Committee Chairman Fred Upton, R-Mich., intends next year to advance a bill that would update many federal regulations to aid in the development of new health products. This planned legislation is meant to aid with efforts to bring to market new health data tools, as well as drugs and medical devices.
Wojcicki, who was a panelist on a roundtable convened by the committee on Tuesday, cited the federal Blue Button Initiative as an example of significant work already underway. Through the initiative, HHS and the Defense and Veterans Affairs departments have allowed people enrolled in Medicare, the VA and the military's Tricare system to fairly easily download data such as medications, lab results, blood pressure readings and known allergies.
"There's an entire ecosystem of companies that could flourish based on thinking of interesting ways to help you understand, to process that," Wojcicki said in an interview after the session.
Among the early entrants in the field is Del Mar, California-based Humetrix, which in 2012 won a federal competition known as the Blue Button Mash Up Challenge with its iBlueButton app. Christopher R. Burrow, a doctor who joined the Humetrix executive team in 2010, has said that making people's prescription history easily available through the app will help reduce the number of deaths and emergency room visits that occur due to medication errors. These contribute to about 700,000 emergency department visits and 120,000 patients hospitalizations caused each year for adverse drug events.
"Just having your mom's medication record available to her when she sees her doctor, or you yourself having your own, goes a long way to preventing adverse drug reactions," Burrow told a recent Federal Trade Commission conference on the privacy of health data. "This really can be critical, crucial information and we are passionate about delivering this service to our users."
As the executive vice president for medical affairs for Humetrix, Burrow also has served as the company's principal data security and privacy officer. He said new federal standards incorporate a secure email protocol called Direct to send a readable summary of a patient's encounter or hospital discharge to an email address.
Even with security steps taken by HHS and developers like Humetrix, deep concerns about protecting the privacy of medical data remain. Burrow noted a federal guidance regarding a process of masking, or de-identifying, health data.
"It states very clearly that gender, five-digit zip code, and date of birth, month, day and year can identify 50 percent of all Americans. That's pretty extraordinary," Burrow said. "So there is a real need to have ways of avoiding putting those three, just those three simple facts together."
Privacy was a concern too with the recent releases of large amounts of Medicare data, which are intended to allow researchers and journalists to study in depth how the program works. The Centers for Medicare and Medicaid Services (CMS) has said that it has taken steps to scrub the identity of patients from the large releases that it has made in recent months, such as the posting of information about payments to doctors. One safeguard is redacting all data that covers fewer than 11 beneficiaries.
When it came to doctors, though, CMS found that the benefit to be gained through study of payment patterns outweighed privacy concerns. CMS aided in efforts to examine this data by posting interactive "dashboards" permitting analysts to compare how per capita spending varies down to the county level and pinpointing the sharply varying burden of chronic diseases in the Medicare population across different parts of the United States.
CMS in general has pushed in the past five years to get more data out to the public to help divine broad trends, said Tricia Neuman, senior vice president of the nonprofit Kaiser Family Foundation and director of its program on Medicare policy.
"Assuming the data are correct, it's hard to see any downside to the public," she said, adding that she has talked about this increased flow of CMS information with doctors, fellow researchers and officials from health plans. "There is a real interest in exploring the data to try to get a better feel for what it going on inside the Medicare program, and how things can be improved."
There may be no more clear proof of both the interest from the health community, and the willingness of HHS to work with it, than the quick rise of Health Datapalooza.
In 2010, HHS and the Institute of Medicine first brought together business leaders and academic researchers with officials from the White House and federal agencies for the event, a kind of trade show for vendors, government officials and assorted technology geeks.
"It started from very humble roots," Niall Brennan of CMS recalled in a 2012 talk. "It wasn't a palooza. It was a meeting with 50 people."
The fifth Datapalooza, held earlier this month, drew some 2,000 entrepreneurs, investors and researchers to Washington. Brennan, now acting director of the Offices of Enterprise Management at the CMS, has stressed that the agency is anxious to work with the public in making the most of its data.
CMS is in the midst of "an evolution cycle," moving away from the role it once has as being in general primarily a payer of claims, Brennan said. Much of the work that that agency officials want to do through the Center for Medicare and Medicaid Innovation will require increased understanding of the messages to be found within the agency's data, he said.
This will be critical, for example, to helping set standards for accountable care organizations, a model of delivering medical care seen as likely to better coordinate the services that people receive. Researchers have said that this could both improve the health of patients, and save CMS money, especially in the cases of older people who may have several chronic illnesses.
"All of the levers that we are trying to pull to transform health care systems are predicated, not entirely on data, but largely on data," Brennan said. "You can't hold an ACO to a threshold without understanding what that ACO population has been like for the last three years."
