An Ignoble Experiment

2. Mobile medical apps need to be regulated for patient safety, FDA official tells House panel

Android devices should not be part of the bring-your-own-device program for Internal Revenue Service employees until the agency reviews Android's security vulnerabilities, says the Treasury Inspector General for Tax Administration.

The IRS rolled out a BYOD pilot program in September 2012 to let employees access the agency's network through their personal mobile devices. Initially, the program was limited to Apple devices. In May 2013--with hundreds of IRS employees participating through their iPhones and iPads--the IRS expanded the program to allow Android devices.

But in a newly released report, dated Sept. 24, TIGTA says the IRS did not adequately consider the security weaknesses of the Android operating system.

The report recommends that the IRS stop allowing Android devices into the BYOD program until it completes a security review that "thoroughly addresses" the risks associated with Android.

Android is vulnerable due to "an open source operating system, a more lenient approval process for inclusion in the regulated app store, multiple third-party unregulated app stores, and lack of timely updates to correct operating system weaknesses," the report says.

The IRS disagreed with the recommendation, saying management did consider security concerns. It also notes that the program is just a pilot and is under evaluation in a secured environment.

Still, the report says TIGTA is "not convinced that the IRS executive" who authorized the program "had enough information to make an informed decision about the risks involved in bringing Android devices into the BYOD pilot."

The report does note the importance of Android if the program advances past the pilot phase, saying it might not be worthwhile to have an agencywide BYOD program that is limited to Apple devices.

For more:
- download the report, 2013-20-108 (.pdf)

Read more about: IRS, TIGTA
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By Ryan McDermott

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3. Forest Service rolls out smartphone maps for national forests

Mobile medical apps need to be regulated because patient safety is at risk when they are used to diagnose or treat a disease, said Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health at a Nov. 19 House Energy and Commerce Committee subcommittee on health hearing.

The FDA's regulation of software as a medical device is based on risk and function, Shuren told the panel, and the FDA treats devices that perform the same function the same way regardless of the platform on which it is used.

"It's not about the platform. It's about the function," said Shuren.

Software becomes a medical device through intended use and diagnosis of disease and conditions or treatment cure mitigation of disease, he said.

"All we are saying is, the functions, when they stay the same, treat them the same, because the impact and the risk to patients is the same," Shuren said. "Simply because they got smaller and I can pick it up and walk out of the room with it, doesn't change the risk to the patients. Why for that reason alone would we treat it differently?"

The FDA issued nonbinding guidance Sept. 25 with their plan of how to regulate mobile apps as medical devices.

If, for instance, an app illuminates an LED light, like prevalent flashlight apps do, the FDA wouldn't consider it a medical device. But if the developer labels and markets it as a light source for doctors to examine patients, the FDA would approach it as it would an ophthalmoscope, the guidance says.

But the FDA might not need that guidance if Congress passes a bill that's currently sitting in the House Energy and Commerce Committee.

The bill (H.R.3303) would amend the Food, Drug and Cosmetic Act to regulate medical software. It would establish three categories of software--clinical, health and medical--with the two former software types not subject to FDA regulation.

But Shuren told the subcommittee that the bill undermines the FDA's authority to assure the safety and effectiveness of high risk medical devices.

The FDA would no longer be able to regulate blood glucose meters and software that is used to analyze pap smear slides, Shuren said.

"It's very confusing to us what this actually accomplishes," he said.

For more:
- go to the hearing page (webcast and prepared testimony available)

Read more about: mobile medical apps, Jeffrey Shuren
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By Zach Rausnitz

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4. Spectrum auction not all about revenue, says OSTP official

The Forest Service has begun offering hundreds of digital maps of national forests for mobile devices through a free third-party app called Avenza PDF Maps.

Maps that show roads, trails and areas designated for motor vehicles within national parks can be downloaded for free. National forest visitor maps, with information on streams, lakes, campgrounds, picnic areas and more, cost $4.99, about half of the cost of the paper versions.

Internet connections can be unreliable or nonexistent in national forests. The app lets users download PDF maps in advance, after which Internet access is not necessary to view them, and gives them the option to add marks and labels.

Navigating a forest with a map "used to mean taking out a folded map, holding onto it tightly so the wind won't blow it away or trying to shelter it from raindrops," the Forest Service says in a blog post.

The device's location appears as a dot on the map, and users can record their GPS tracks.

The app is available for iPhones, iPads and Android devices.

For more:
- go to the Forest Service blog post
- download the agency's instructions for using the app (.pdf)

Read more about: iOS, Android
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By Molly Bernhart Walker

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5. Ohio CIO: States need to know FirstNet has a sustainable business model

*Correction appended

The White House supports a letter to the Federal Communications Commission from the Justice Department's Antitrust Division saying that the FCC could consider imposing caps on the two largest carriers' participation in an upcoming spectrum auction should the agency determine they could gain an unfair market advantage.

The DOJ pointed out that market power can lead to higher prices, and it can isolate a company from the competitive pressures to expand service or improve quality, said Tom Power, deputy chief technology officer for telecommunications at the White House's Office of Science and Technology Policy. Power spoke Nov. 21 at an event hosted by the New America Foundation.

"When the issue of spectrum auctions was first developed, the goal was not raising revenue. The goal was efficient allocation of spectrum. So, that's still in the statute. It's still the default preferred approach," said Power.

However, Power noted that there has been no formal determination.

"No one has called for any carriers to be excluded," he said.

FCC Chairman Tom Wheeler has also yet to take a clear stance on what carriers will be permitted to participate, or if participation will include any caveats.

Verizon and AT&T, the two largest carriers, and some lawmakers have said that an unrestricted auction would promote the most competition and yield the greatest revenue. Revenue from the forthcoming spectrum auction will go toward funding the planned nationwide interoperable public safety broadband network, or FirstNet. The network program office needs $7 billion from the auction to deploy the public safety network and around $2 billion for the cost of re-packing spectrum from television broadcasters and making it available to wireless carriers.

While speaking at the event, Power said he has been encouraged by agencies' efforts to free up and share spectrum.

"I think there's sort of this perception or caricature of the relationship between the agencies and industry as being this sort of tug of war on spectrum with both sides not acting reasonably and the agencies hoarding spectrum and all that," said Power.

"But if you look at the work that these people are actually doing--and I'll single out DoD and Teri Takai and her team over there--it's really, really been impressive," he said.

CORRECTION NOV 27 12:45 P.M.: An earlier version of this article mischaracterized the DOJ's stance on carrier competition in the forthcoming spectrum auction. The department's letter says the FCC should consider capping spectrum acquisition by the two largest carriers if the move is needed to foster competition. As Power said at the event, "no one has called for any carriers to be excluded."

For more:
- go to the event page (includes archived webcast)

Read more about: Verizon, spectrum auctions, AT&T
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By Molly Bernhart Walker

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