Before using a favorite smartphone or tablet software application to check a patient in the field, responders may have to refer to the U.S. Food and Drug Administration’s (FDA’s) regulated medical device list. In July, the FDA released a draft notice of its proposed oversight of select apps that turn mobile devices into medical devices, inviting public comment.
The agency’s intent is to target mobile medical apps that would harm patients if they were to malfunction. For example, apps that provide radiologic images for diagnosis or turn a mobile device into an electrocardiogram would be regulated; those that calculate calories or define medical terms would be exempt from agency oversight.
More specifically, the agency proposes oversight of mobile medical apps that are used as accessories to FDA-regulated medical devices or transform mobile communication devices into regulated medical devices through attachments or sensors.
“Draft Guidance for Industry and Food and Drug Administration Staff—Mobile Medical Applications” is available at gpo.gov/fdsys/pkg/FR-2011-07-21/pdf/2011-18537.pdf. Comments are due by Oct. 19.
FCC Strengthens Wireless Location ID
The Federal Communications Commission (FCC) announced several decisions at its July meeting designed to strengthen wireless phone access to 911 emergency services and also requested comment on how to improve technology for 911 calls made via Voice over Internet Protocol (VoIP).
Among the new Enhanced 911 (E911) regulations adopted to improve location identification accuracy, all wireless carriers will be required by 2019 to implement caller location information through GPS or similar technology installed in callers’ handsets and phase out the less accurate practice of identifying location by triangulating signals from cell sites. Wireless carriers must also periodically test their E911 location accuracy and share the results with certain emergency response officials.
FCC commissioners requested comment on how the agency might ensure that VoIP technology provide automatic location information for 911 calls and ways to improve location accuracy for all 911 calls made from indoor locations, such as a particular floor in a large office building.
The decisions and discussion issues are available at
transition.fcc.gov/Daily_Releases/Daily_Business/2011/db0713/FCC-11-107A1.pdf. Comments are due by Sept.13.
Narrowbanding Deadline Waiver Option Offered
Licensees who require additional time to comply with the narrowbanding requirements now have guidelines from the Federal Communications Commission (FCC) explaining how to file for a waiver of the mandatory Jan. 1, 2013, deadline. Licensees operating in the 150–174 MHz and 421–512 MHz bands must adopt narrowband technology—12.5 kHz or narrower—under FCC narrowbanding requirements or face significant penalties.
In a July Public Notice reiterating the deadline, the agency also requested specific content to be included in deadline waiver requests. Licensees are asked to detail steps already taken to plan and initiate the transition; describe the system’s size and complexity; explain how the transition is affected by interoperability relationships or interdependencies with neighboring systems; and discuss plans to minimize the impact of the delayed transition on adjacent channel operations. Licensees are also asked to provide a proposed timetable for completing the transition and related information.
Though the deadline is more than a year away, the guidance is intended to accelerate the waiver review process. Licensees are asked to submit requests before the end of 2011.
The Public Notice, which also answers frequently asked questions, is at hraunfoss.fcc.gov/edocs_public/attachmatch/DA-11-1189A1.pdf.
Volunteer Tax Benefit Bill Progresses
Following on the heels of Senate passage of the Volunteer Responder Incentive Protection Reauthorization Act (VRIPRA) in May, the House acted to restore federal income tax exemptions enjoyed by volunteer emergency responders before they were revoked last year. Without this legislation, volunteer firefighters and emergency medical responders must pay taxes on property tax exemptions and similar benefits they receive from departments that use such incentives to attract and retain volunteers.
The House bill differs from the Senate bill, and compromise is necessary for both houses to pass the same bill for the president to sign. The House bill would take effect Jan. 1, 2012, and run through Dec. 31, 2015, while the Senate bill would be retroactive to Jan. 1, 2011, and run through December 31, 2013.
The House bill was sent to the Ways and Means Committee; the Senate bill remains in the Finance Committee.
Measles Alert
With measles having been eliminated in the United States in 2000, many young EMS responders and emergency department personnel may not recognize signs of the current record outbreak or know how to protect themselves, suggests the Centers for Disease Control and Prevention (CDC).
A Health Advisory issued to health care organizations, agencies and personnel in June by the CDC reports the highest number of confirmed measles cases in the U.S. during the first half of 2011 since 1996. The agency attributes the outbreak to the spread of infection from large outbreaks in countries with low vaccination rates.
The CDC recommends that health care workers consider measles as a diagnosis in anyone with a fever of 101° F or higher accompanied by a full-body rash for three or more days accompanied by a cough and runny nose, particularly if the patient has recently traveled abroad or been in contact with someone experiencing a similar illness.
The official CDC Health Advisory is at emergency.cdc.gov/HAN/han00323.asp.
