Tech giants move to protect wearables - Ashley Gold - POLITICO.com

Apple tried to assure Congress the data passing through its software won’t be sold. | AP Photo

Technology giants poised to reap billions from selling “wearables” and other personal health technology are furiously lobbying Capitol Hill with a strong message: Don’t regulate our Fitbits.

The Affordable Care Act calls for patients to become bigger players in their own health, and companies that make personal health devices want Medicare to incentivize doctors who encourage patients to use them.

As the market for the devices grows, however, the companies that make them and collect the data are coming under increasing scrutiny over privacy and security issues, because everything from heartbeats to insulin deficiencies will be stored on the devices and possibly on the cloud. Under the old Health Insurance Portability and Accountability Act (HIPAA), these devices – Fitbits, Jawbones and the like – aren’t covered. But some regulators and lawmakers believe that at least some of them should be regulated like other medical devices.

The tech industry is trying to stay one step ahead of the regulators, and Apple is leading the way.

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Apple drew attention to the burgeoning consumer-generated health data scene this month with the introduction of HealthKit, which serves as an iPhone dashboard for consumer health and medical apps. Over the summer, Apple’s top lobbyist Amber Cottle called on members of the Senate and the House on “issues related to consumer health data,” according to a disclosure filed in late July.

Earlier this month Bud Tribble, Apple’s chief technology officer, and Afshad Mistri, its health product manager, briefed the House Energy and Commerce Committee on how the company intends to store and use consumer health data.

Apple has tried to assure Congress and consumers that the health information passing through its software won’t be sold and will be tremendously difficult to hack. But studies of existing wearable health apps have shown they frequently share information with data brokers and in most cases have few privacy controls.

The Federal Trade Commission is worried about consumer-generated health data. On Sept. 15, FTC Chairwoman Edith Ramirez reiterated a call she has made since 2012 for Congress to pass baseline privacy legislation that would cover wearables and consumer health data.

“Wearable devices can help consumers stay fit and healthy,” Ramirez told POLITICO. “But as these devices become more popular, it’s especially important that they keep our health information private and secure.”

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Apple’s entry made a splash but other companies have lobbied for months to make the regulatory environment friendly for their products and services.

Intel Corp., which makes the chips that power many devices and recently purchased Basis Science, which makes wearable technologies for health and wellness. Intel spent $1.45 million lobbying earlier this year, according to a Senate filing. The topics included telehealth wearables, remote patient monitoring and the inclusion of patient-generated data in meaningful use Stage 3. HHS’ Office of the National Coordinator for Health IT says it will issue the requirements for that stage of the electronic health records stimulus program this winter.

Intel also lobbied for programs that incentivize researchers to use personalized medicine and genetic profiles in their drug studies. A major Obamacare-created program called the Patient-Centered Outcomes Research Institute is incorporating this type of data in the programs it funds.

Alice Borrelli, director of global health care policy for Intel, said that although privacy is a “huge concern” for patient-generated data, she doesn’t see the need for legislation just yet.

“Right now, we need to collect more information and see how it’s being used, and if there are violations, to address those, rather than have a preemptive lawmaking,” Borrelli said.

Others argue that FTC and FDA should keep their hands off wearable data because it doesn’t require the same level of protection as traditional medical records, which are protected by HIPAA.

“You can’t treat FitBit health data the same way you treat your BlueCross BlueShield data,” said Carl M. Szabo of Netchoice, an e-commerce trade association that represents leading tech companies. “Health apps are not a one-size-fits-all category.”