It's been a busy few months for ACT | The App Association, which recently came out against the proposed Compliance with Court Orders Act of 2016.
The legislation, proposed by Senate Select Committee on Intelligence Chairman Richard Burr (R-N.C.) and Vice Chairman Dianne Feinstein (D-Calif.), reinforces that all entities must comply with court orders to help access encrypted data.
However, the App Association views the bill as mandating tech vendors to build a backdoor into every app and connected device. It calls the proposal a "nonstarter" move that could "strangle" the industry.
Morgan Reed, executive director of ACT | The App Association, told FierceMobileHealthcare in an interview that the legislation would be incredibly damaging to consumer trust in connected health applications.
"History shows any backdoor engineered into a secure system inevitably opens up troves of sensitive information to criminals," he said "In the health context, this would lead to private health data and financial information being sold on the black market. The proposed bill not only requires app makers to build backdoors into their products, but it also forces platforms to 'ensure' every app they sell has a backdoor."
Reed added that such a move would "turn software distribution companies into the police, undermining the trust and security that is essential to protecting health records."
He also spoke about recent federal oversight actions for mHealth, trends in the market and what his organization anticipates for healthcare in the second half of the year.
FierceMobileHealthcare: What would ACT like to see happen with regard to modernizing the Federal Trade Commission?
Morgan Reed: Modernizing the FTC is important, but it's critical to remember the FTC is the "cop on the beat." They don't write the regulations or describe reimbursement mechanisms in the same way that Health and Human Services does. The House Energy and Commerce Committee has proposed a slate of legislation that looks at modernizing the FTC to make it more responsive and accountable. We are looking at all of the proposed bills, and continue to work with the committee and the FTC to ensure small companies can more easily navigate the regulatory process and focus on developing innovative solutions that make our lives better.
FMH: The app developer tool from the FTC and other agencies has been embraced by your group. What makes the tool a useful resource?
Reed: We work regularly with the FTC, U.S. Food and Drug Administration and the HHS Office for Civil Rights to improve the tools they use for communicating. It's absurd to think that in this era, we still find government websites that are so difficult to navigate that key regulatory elements are essentially invisible. This tool is a good starting point, and we applaud efforts to move interface design into a more recent decade.
However, the tool doesn't address some of the key questions that companies are asking. While it's important for companies to know where they fit in the regulatory ecosystem, the most pressing issue is understanding how to meet those requirements.
There is still work to be done to better explain how to provide cloud storage, how to determine what "on behalf of" means, and how to craft a business associate agreement for third party data usage. Overall, questions remain around many elements of HIPAA, and like any website or app, the tool still needs to be improved and expanded.
FMH: What is the biggest hurdle to the proliferation of mobile tools by providers?
Reed: For mobile health innovation to continue, the system must properly reimburse for remote patient monitoring and the use of health and wellness devices by consumers. Without a way for physicians and health systems to recover the cost of supporting these technologies, healthcare providers will continue to push for patients to come in, sit in the waiting room reading old magazines, all to spend 15 minutes with a physician. The system must make economic sense for doctors and health providers, while ultimately making sense for us as consumers.
FMH: Looking ahead to 2017, what do you expect to take place with mHealth?
Reed: Improving healthcare outcomes through the use of technology will become more essential to making value-based medicine work. But, I believe that without better data on effectiveness and clarity of regulation, we will continue to be rutted in the pilot-project phase. I am hopeful that 2017 will be a breakout year, but it will take a lot of work.
Editor's Note: This interview has been edited for clarity and length.