House Republicans on the Communications Subcommittee said they're wary that the Food and Drug Administration’s proposal to regulate mobile health applications and devices that use them could slow innovation in the health IT space, according to a majority memo recently posted to the subcommittee’s website. FDA classification of cellphones with health applications as medical devices could subject entrepreneurs to lengthy clearance or approval requirements, the memo said. If the agency considers cellphones with health applications to be medical devices it could have the negative result of stalling innovation, investment and job creation and “ultimately impact the larger wireless ecosystem,” according to the memo. The comments came ahead of Tuesday’s 10 a.m. Communications Subcommittee hearing in 2123 Rayburn. Robert Jarrin, Qualcomm senior director-government affairs, plans to say he’s particularly concerned that the FDA’s failure to release its final guidance on mobile medical applications “has created uncertainty among countless budding entrepreneurs and large corporations that fear the prospect of facing FDA regulation,” according to his advance testimony. Jarrin will tell lawmakers that the guidance should be promptly finalized, include specific examples of mobile devices that would not be subject to regulation, provide more clarity on mobile health terms, and coordinate its efforts through a dedicated FDA mobile health office, among other suggestions. George Ford, chief economist at the Phoenix Center, is also set to tell lawmakers that FDA regulation of mobile health applications could slow the rate of innovation and growth of the wireless industry, according to his written testimony. Jonathan Spalter, chairman of Mobile Future, expects to tell lawmakers there’s a “clear cut need for some degree of oversight over clinical treatment,” but mobile health innovators need better guidance on which agencies from which they must receive federal approval, according to his written testimony. Spalter plans to point to the confusion, duplication and jurisdictional overlap of medical device regulation from the FDA, the FCC, the FTC, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of the National Controller. There must be a clear definition of when mobile health devices and applications are subject to federal regulation, said Spalter’s testimony. And the government should ensure a speedy approval process for those devices and applications that are subject to regulation so to “keep pace with emerging technology and meet consumer demand,” according to his testimony. Benjamin Chodor, CEO of Happtique, a provider of mobile health services, plans to tell lawmakers that medical device excise taxes should not apply to cellphones, tablets or mobile health apps, according to his written testimony. Such taxes would slow innovation by placing “burdensome costs on app developers in a new and growing market,” he expects to say.
House Republicans on the Communications Subcommittee said they're wary that the Food and Drug Administration’s proposal to regulate mobile health applications and devices that use them could slow innovation in the health IT space, according to a majority memo recently posted to the subcommittee’s website. FDA classification of cellphones with health applications as medical devices could subject entrepreneurs to lengthy clearance or approval requirements, the memo said. If the agency considers cellphones with health applications to be medical devices it could have the negative result of stalling innovation, investment and job creation and “ultimately impact the larger wireless ecosystem,” according to the memo. The comments came ahead of Tuesday’s 10 a.m. Communications Subcommittee hearing in 2123 Rayburn. Robert Jarrin, Qualcomm senior director-government affairs, plans to say he’s particularly concerned that the FDA’s failure to release its final guidance on mobile medical applications “has created uncertainty among countless budding entrepreneurs and large corporations that fear the prospect of facing FDA regulation,” according to his advance testimony. Jarrin will tell lawmakers that the guidance should be promptly finalized, include specific examples of mobile devices that would not be subject to regulation, provide more clarity on mobile health terms, and coordinate its efforts through a dedicated FDA mobile health office, among other suggestions. George Ford, chief economist at the Phoenix Center, is also set to tell lawmakers that FDA regulation of mobile health applications could slow the rate of innovation and growth of the wireless industry, according to his written testimony. Jonathan Spalter, chairman of Mobile Future, expects to tell lawmakers there’s a “clear cut need for some degree of oversight over clinical treatment,” but mobile health innovators need better guidance on which agencies from which they must receive federal approval, according to his written testimony. Spalter plans to point to the confusion, duplication and jurisdictional overlap of medical device regulation from the FDA, the FCC, the FTC, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of the National Controller. There must be a clear definition of when mobile health devices and applications are subject to federal regulation, said Spalter’s testimony. And the government should ensure a speedy approval process for those devices and applications that are subject to regulation so to “keep pace with emerging technology and meet consumer demand,” according to his testimony. Benjamin Chodor, CEO of Happtique, a provider of mobile health services, plans to tell lawmakers that medical device excise taxes should not apply to cellphones, tablets or mobile health apps, according to his written testimony. Such taxes would slow innovation by placing “burdensome costs on app developers in a new and growing market,” he expects to say.
Changing 911 technologies call for a change in behavior and federal advocacy, speakers told the National Number Emergency Association Monday. Public safety officials from around the country are gathering in Washington for the association’s 911 Goes to Washington meeting, which continues Tuesday. “We become a part of the government procedure,” said NENA Second Vice President Christy Williams of the 911 directors’ visits to Capitol Hill offices this week. She noted that more than 31 states and territories were represented at this year’s meeting. Speakers discussed the best ways to approach federal government officials as well as the challenge of text-to-911 and potential spectrum interference. (See separate report in this issue.)
The nature of 911 is changing, the members of the National Emergency Number Association were told at its 911 Goes to Washington meeting. Multiple new technologies are transforming how regulators and industry are seeing the service, and Monday sessions focused on text-to-911 initiatives, the broader move to an Internet Protocol-based next-generation 911 and the move within the wireless industry of tracking callers’ locations, all of which call for a reassessment of current codes, laws and practices, particularly at the state level.
CEA should “bring an end to its misguided campaign to avoid implementing closed captioning functionality on removable media players,” said five groups representing the hearing-impaired and a program at a university that teaches such people. The plea came in a letter to the FCC on the association’s Feb. 26 filing (http://bit.ly/WtbCuD) on CEA’s request for the agency to redo Internet Protocol captioning rules so some consumer electronics like stand-alone DVD players don’t fall under them. Instead of pursuing that attempt to change last year’s IP captioning order, the association should “turn to the task of ensuring that all consumers who purchase removable media players and discs can experience the benefits of video programming on equal terms,” the groups said in docket 11-154 (http://bit.ly/Z3Ywk5). “The history of the Television Decoder Circuitry Act supports the Commission’s decision to cover removable media players under Section 203(a) and undermines CEA’s arguments about the cost of adding closed captioning functionality to such players.” The 1990 law also was opposed by CEA’s predecessor, the Electronic Industries Alliance, said the Association of Late-Deafened Adults, National Association of the Deaf, Telecommunications for the Deaf and Hard of Hearing, Gallaudet University’s Technology Access Program and others. “EIA’s fears that closed captioning functionality would send the price of television sets spiraling out of control never materialized.” A few years after passage of the act, EIA “abandoned its public opposition” to captioning functionality on TV sets, said the groups, which also include the Cerebral Palsy and Deaf Organization and Deaf Hard of Hearing Consumer Advocacy Network. CEA, in a filing also posted Friday in the docket, asked the commission to approve the association’s petition for reconsideration of the IP captioning rules. That’s “because some of the issues raised in the proceeding on emergency information and video description are related” to the petition, executives at Samsung and the association told aides to all FCC members (http://bit.ly/WlkiEk).
CEA should “bring an end to its misguided campaign to avoid implementing closed captioning functionality on removable media players,” said five groups representing the hearing-impaired and a program at a university that teaches such people. The plea came in a letter to the FCC on the association’s Feb. 26 filing (http://bit.ly/WtbCuD) on CEA’s request for the agency to redo Internet Protocol captioning rules so some consumer electronics like stand-alone DVD players don’t fall under them. Instead of pursuing that attempt to change last year’s IP captioning order, the association should “turn to the task of ensuring that all consumers who purchase removable media players and discs can experience the benefits of video programming on equal terms,” the groups said in docket 11-154 (http://bit.ly/Z3Ywk5). “The history of the Television Decoder Circuitry Act supports the Commission’s decision to cover removable media players under Section 203(a) and undermines CEA’s arguments about the cost of adding closed captioning functionality to such players.” The 1990 law also was opposed by CEA’s predecessor, the Electronic Industries Alliance, said the Association of Late-Deafened Adults, National Association of the Deaf, Telecommunications for the Deaf and Hard of Hearing, Gallaudet University’s Technology Access Program and others. “EIA’s fears that closed captioning functionality would send the price of television sets spiraling out of control never materialized.” A few years after passage of the act, EIA “abandoned its public opposition” to captioning functionality on TV sets, said the groups. They also include the Cerebral Palsy and Deaf Organization and Deaf Hard of Hearing Consumer Advocacy Network. CEA, in a filing also posted Friday in the docket, asked the commission to approve the association’s petition for reconsideration of the IP captioning rules. That’s “because some of the issues raised in the proceeding on emergency information and video description are related” to the petition, executives at Samsung and the association told aides to all FCC members (http://bit.ly/WlkiEk).
CEA should “bring an end to its misguided campaign to avoid implementing closed captioning functionality on removable media players,” said five groups representing the hearing-impaired and a program at a university that teaches such people. The plea came in a letter to the FCC on the association’s Feb. 26 filing (http://bit.ly/WtbCuD) on CEA’s request for the agency to redo Internet Protocol captioning rules so some consumer electronics like stand-alone DVD players don’t fall under them. Instead of pursuing that attempt to change last year’s IP captioning order, the association should “turn to the task of ensuring that all consumers who purchase removable media players and discs can experience the benefits of video programming on equal terms,” the groups said in docket 11-154 (http://bit.ly/Z3Ywk5). “The history of the Television Decoder Circuitry Act supports the Commission’s decision to cover removable media players under Section 203(a) and undermines CEA’s arguments about the cost of adding closed captioning functionality to such players.” The 1990 law also was opposed by CEA’s predecessor, the Electronic Industries Alliance, said the Association of Late-Deafened Adults, National Association of the Deaf, Telecommunications for the Deaf and Hard of Hearing, Gallaudet University’s Technology Access Program and others. “EIA’s fears that closed captioning functionality would send the price of television sets spiraling out of control never materialized.” A few years after passage of the act, EIA “abandoned its public opposition” to captioning functionality on TV sets, said the groups. They also include the Cerebral Palsy and Deaf Organization and Deaf Hard of Hearing Consumer Advocacy Network. CEA, in a filing also posted Friday in the docket, asked the commission to approve the association’s petition for reconsideration of the IP captioning rules. That’s “because some of the issues raised in the proceeding on emergency information and video description are related” to the petition, executives at Samsung and the association told aides to all FCC members (http://bit.ly/WlkiEk).
The FCC Public Safety Bureau will refresh the record on what it should do about prank calls to 911 from “nonservice-initialized” (NSI) handsets -- cellphones no longer connected to a carrier network. In 2008, the FCC sought comments in response to a petition from public safety groups (CD March 5 p5/08). Many of the calls come from teens aware that calls on old cellphones must be forwarded by carriers under FCC rules, but can’t be traced. The FCC in 1996 at the urging of public safety imposed a requirement that NSI handsets can still make 911 calls. In seeking additional comment, the bureau cited a recent filing by the National Emergency Number Association. “According to NENA, ‘PSAPs face an ever-growing onslaught of non-emergency calls to 911 from NSI devices,'” the bureau said (http://bit.ly/1528R3X). “Moreover, in recently filed comments in another docket, NENA states that there is now a ‘consensus view that the promotion of NSI devices does more harm than good.’ NENA further asserts that ‘most charities and domestic violence advocates [have] abandoned the practice of distributing NSI devices.'” Comments and replies will be due following publication in the Federal Register.
The government plans to rely on the private sector to help foster information sharing and civil liberties protection standards as it works to implement the Obama administration’s cybersecurity executive order, said Ari Schwartz, senior Internet policy adviser at the Commerce Department. The order, introduced last month during the State of the Union speech, will focus on expanding information sharing, protecting privacy and civil liberties, and the development of a framework to reduce cyber risks to critical infrastructure, he said Thursday at a USTelecom event in Washington.
The government plans to rely on the private sector to help foster information sharing and civil liberties protection standards as it works to implement the Obama administration’s cybersecurity executive order, said Ari Schwartz, senior Internet policy adviser at the Commerce Department. The order, introduced last month during the State of the Union speech, will focus on expanding information sharing, protecting privacy and civil liberties, and the development of a framework to reduce cyber risks to critical infrastructure, he said Thursday at a USTelecom event in Washington.