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The challenge – and opportunity – of regulating new ideas in science and technology

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Innovation in science and technology holds promise to improve our lives. But disruptive business models, do-it-yourself medical devices, and open platforms also introduce corporate and personal risks. How can the public stay safe from unknown consequences as a company’s product or service matures? In a recent panel co-sponsored by Stanford’s Rock Center for Corporate Governance and Center for Law and the Biosciences, experts in law, business, and ethics discussed what happens when science and technology outrun the law.

Talk of drones, app-based car services, and music-sharing technologies teased out key issues currently disrupting legal paradigms. But biomedical science took center stage. “Health is more regulated than any other [area]” said panelist Hank Greely, JD, the Deane F. and Kate Edelman Johnson Professor of Law and director of the Center for Law and the Biosciences. He characterized the FDA’s processes as useful in slowing innovation in the health space but noted that rigorous pre-market regulation “won’t work in most parts of the economy.”

What happens when regulation is beyond reach? Greely noted that even if the FDA could limit an entrepreneurial company, it couldn’t conquer the DIY market. He referenced a procedure known as transcranial direct current stimulation, which, by applying electrodes to the head, can feel like “Adderall through a wire” or alter a person’s mood according to placement. A transmitting device is so simple to make, Greely said, “the hardest part will be finding an open Radio Shack.”

Moderator Dan Siciliano, JD, faculty director of the Rock Center and professor of the practice of law, asked the panelists which under-regulated technologies they found frightening. Vapor cigarettes, answered Eleanor Lacey, JD, for luring youth through fruit flavors and targeting them through advertising channels prohibited for regular cigarettes. (As previously reported on Scope, the FDA announced last spring that it would regulate the sale, but not marketing, of e-cigarettes.)

Lacey, vice president, general counsel and secretary of SurveyMonkey, discussed regulation issues involving health information that is transmitted on the company’s platform, where users own their data. She pointed to instances of users creating surveys on which respondents shared HIPAA-protected information, admitted suicidal thoughts, or confessed to crimes. The company cooperates with law enforcement in a very narrow set of sensitive situations but also upholds neutrality of the user-owned space and the user right to control the content: “You don’t want us to be able to shut it down,” Lacey said.

Siciliano asked which potentially disruptive technologies most excited panelists. For Greely, it was genome editing - and he called out CRISPR (which allows researchers to make small, precise and permanent changes in the DNA of animal and human cells) for making genome editing "at least an order of magnitude better, faster, cheaper." Alex Gould, co-founder and general partner at The Valley Fund and a lecturer in Stanford’s Department of Economics, chose, while “not a matter of life and death,” the mash-up space in music – imagine “90 percent Taylor Swift plus a Jay Z beat,” for example. An abundance of high-quality content for consumers to play with and distribute will complicate copyright law, he acknowledged.

Gould noted that as the legal system faces unforeseen challenges, new regulations that follow may slow the pace of innovation in certain areas. Lowering risk in this way could be a good thing even for venture capitalists, as investments that move ahead of the law could prove costly later on. Risky venture or not, the players gonna play, Gould indicated. And that’s a good thing, too, he said. “Only the ones who have guts and have thought about it a little bit are the ones who are going to go out and go after it.”

Emily Hite is the content and communications manager for the Rock Center for Corporate Governance and the Steyer-Taylor Center for Energy Policy and Finance at Stanford and a former social media producer for Stanford Medicine’s Office of Communication and Public Affairs.

Previously: Medical student-turned-entrepreneur harnesses Google Glass to improve doctor-patient relationship, And baby makes four? KQED Forum guests discuss approval of three-parent IVF in UK, E-Cigarettes: The explosion of vaping is about to be regulated and Recognizing mental health problems through Facebook
Image courtesy of Rock Center

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