The champion of legislation to give the Food and Drug Administration (FDA) regulatory power over mobile and wireless health apps, gadgets and other tools believes his plan is something industry wants and consumers need.
“The tech community needs confidence in a consistent, reliable framework for wireless health. The FDA has a critical role to play. Today, there is no confidence [among] industry. It’s nonexistent,” Rep. Mike Honda (D-Calif.), sponsor of the Healthcare Innovation and Marketplace Technologies Act (HIMTA), said in an interview with the Wall Street Journal’s Venture Capital Dispatch blog.
Honda, who represents a large part of Silicon Valley, said he continues to discuss the potential setup of his proposed FDA Office of Wireless Health with technology industry associations, law firms, venture capitalists, healthcare providers, patient-safety groups. “We want all these players to be involved,” he told the Journal.
On the consumer side, Honda expressed the belief that consumers should care about the legislation because new technologies may open up access to care. “Without it, people will not be able to get services they need. Everybody today has a mobile device, and everybody today is a participant in their own health care. People want instant access to their medical records, on their devices, and we need to give the government the expertise [to regulate this area],” the seven-term congressman said in the interview.
In addition to creating an Office Wireless Health at FDA, the proposed legislation, first introduced in December during the lame-duck session of the previous Congress, would fund several innovation challenges, provide low-interest loans and tax breaks to help physician practices purchase non-EHR healthcare technology and offer grants for providers to train employees on using health IT.
Honda, who must reintroduce the bill in the new Congress, said that certain provisions make the legislation feasible even in this time of deep partisan divide and pressure to rein in government spending. He promised that the new version would contain new language based on unspecified feedback his office has received on the earlier bill.
“This could create jobs, and help innovators. There is a provision in this bill to create low-interest loan programs for entrepreneurs, and prizes and tax incentives for disruptive technologies,” Honda said.
“There is money [to create a new FDA office], and there should be the will. My job is to create that political will,” Honda added.
He suggested that the Office of Wireless Health be staffed by people with strong technology backgrounds. “The situation today is kind of like the judicial system, back when there were early lawsuits about technology. No judge really knew about that stuff. They had to be trained,” Honda said.