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2013 was a remarkable year for digital health.
Health technology was one of the hottest sectors in Silicon Valley in 2013, with investors pouring $1.5 billion into the space by the end of the third quarter. Entrepreneurs jumped into health care to take advantage of the Affordable Care Act (ACA) and other health reforms. And in 2013, doctors proved far more willing than ever before to adopt digital technologies, partly thanks to federal cash incentives: Under the government’s “Meaningful Use” guidelines, doctors who shift from paper-based records to electronic health records are eligible to receive large checks in the mail.
It wasn’t all good news. The Obama Administration took a hit when the newly launched HealthCare.gov site failed to function. Personal genomics service 23andMe became the target of a regulatory crackdown, and Samsung debuted its first smartwatch, the clunky Galaxy Gear, impressing no one.
After consulting with the experts, here are our picks for the most significant health-tech stories this year.
The flawed Healthcare.gov rollout
The U.S. government promised to bring affordable health care to all Americans this year. But when the federal exchange launched on Nov. 1, the site was plagued with bugs. Thousands of people could not login or register, let alone peruse cheaper insurance options.
“For me, the defining moment of the year was when President Obama said on Nov. 14, ‘We fumbled the rollout on this healthcare law’,” said LaMontagne. All too often, it takes a full-on public relations fiasco to highlight the flaws with the system.
Senior technologists in the Obama administration took most of the flak, which is not entirely fair given that this is not the first poorly-designed federal website. Government sites are notoriously bad: One of the authors of the Affordable Care Act, Dr. Bob Kocher, joked in an interview with me that HealthCare.gov was actually one of the “best looking” he’s seen. Nevertheless, it simply didn’t work right.
The feds promised to bring in the “best and brightest” to fix HealthCare.gov, which prompted hotshot web developers to offer their services. Now the guy who used to run Microsoft Office has stepped in to oversee the site and its extensive back-end infrastructure.
The silver lining? Silicon Valley’s top talent became committed to improving government websites for the first time. Entrepreneurs started building their own versions of the site (these three coders sat in a coffee shop for three days to build HealthSherpa). The more talented young people interested in building better health insurance exchanges, the better.
Regulators versus startups
Above: 23andMe sells its genetic test directly to consumers
In late November, genetic testing startup 23andMe received an order from the Food and Drug Administration to stop selling and marketing its genetic testing kit. The firm still offers ancestry features and customers can download the raw data, but it won’t provide full health reports without FDA approval.
This was a huge story, which provoked debate from bioethics professors, geneticists, doctors, and patients. This tussle between health care startups and federal regulators was a major theme in 2013.
In the coming year, we’re likely to see more collaboration between innovators and regulators — two weeks after receiving the injunction, 23andMe made significant concessions and agreed to work with the feds.
At the end of the year, we also saw the FDA clarify a few things for entrepreneurs. The agency released its final guidance in September on how it plans to govern mobile health applications. I argued that this effectively removed the biggest roadblock to medical app innovation. Entrepreneurs and investors could breathe a lot easier, knowing that the feds would be unlikely to regulate their apps.
The final guidance “should allow developers and other stakeholders to have more regulatory certainty with respect to mobile app innovation in the health and medical industry,” Corey Ackerman, president of health app marketplace Happtique, told me. The hope is that it will unlock yet more investment in mobile health in 2014.
In 2013, the press raved about the “wearable technology” trend, which includes fitness trackers, health monitoring tools, and smartwatches. Simply stick a sensor on a fashion accessory, and you’ll probably raise venture funding — wearables are that trendy.
However, we’re just at the very early stages of the wearable device trend. I believe that we’re very much in the data collection phase (“your heart rate increased”), but these devices are not yet giving us meaningful insights in real-time (“when you’re in the vicinity of your mother-in-law, your blood pressure spikes”). We’re just seeing the first generation of smartwatches and fitness trackers hit the market, which merely hint at the possibilities for the space.
We’re likely to see plenty more wearable devices in 2014, given that some of the largest tech companies are making big investments in the trend. While Apple has yet to confirm the existence of its hotly anticipated “iWatch,” Samsung launched its Galaxy Gear smartwatch in September. VentureBeat broke the news with our early look at a prototype of the Galaxy Gear, which we dubbed a 21st-century calculator watch. Readers and the media responded by viciously critiquing the device’s design, with good reason. The watch dwarfs a dainty wrist. Clearly, the fashion industry was not consulted.
The big takeaway for Samsung, Apple, and other vendors that are moving into the wearables market? Don’t pack the device with too many features or it will feel bulky rather than slick and stylish. Wearables need to be wearable.
No more patenting laws of nature
In May, the Supreme Court determined that human genes should not be patented in a landmark case for health care. At the center of the debate was Utah-based Myriad Genetics. Scientists at that company had discovered two genes — BRCA 1 and BRCA2 — that are associated with hereditary breast and ovarian cancer. The company patented these discoveries, which immediately provoked debate in the medical community.
The Supreme Court ultimately ruled in favor of scientists, who argue that patents like these stifle research and medical diagnostic testing. Because of its patent, Myriad was in a position to prevent other researchers from testing, studying, or even looking at these genes, and it also held the exclusive rights to any mutations along those genes, groups like the American Civil Liberties Union (ACLU) claimed.
In the immediate aftermath of this decision, biotech firms began to develop their own test for BRCA, which should significantly drive down the price for patients. It also prompted local courts to rule against this kind of intellectual property, with the argument that natural phenomena should not be patented. In November, the California court made an unprecedented move by striking down a patent held by a San Diego-based diagnostics company called Sequenom. Sequenom had patented the discovery that a pregnant woman’s blood contains a small amount of fetal DNA — a patent that would have blocked genetic testing of pregnant women.
Calico’s fight against death
Above: Art Levinson turned down a number of high-profile CEO gigs before joining Calico
In September, Google chief executive Larry Page announced his latest “moonshot,” a mysterious new venture to extend the human life span. We’ve learned that biotechnology mogul Arthur Levinson, 63, who sat on both Google and Apple’s boards and formerly served as the chief executive at Genentech, will lead Calico as its CEO.
Levinson has already recruited some heavyweights in the field of genetics and anti-aging technology, including Dr. Cynthia Kenyon, who discovered a simple genetic mutation that can double the lifespan of a simple worm, C. elegans.
Calico is the most ambitious stab at reversing or slowing down aging to date. For anyone who craves immortality or a healthier life, it’s one to watch.