The US Food and Drug Administration (FDA) outlined new draft guidelines, suggesting how it intends to regulate mobile medical applications.
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| Source: FDA |
The FDA announced that it seeks public input on the proposed approach for certain medicine and health mobile applications. The agency said that currently, mobile medical apps include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device.
The FDA's draft guidance defines a small subset of mobile medical apps that may impact the performance or functionality of currently regulated medical devices including apps that:
- Are used as an accessory to medical device already regulated by the FDA
- Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."
We at Aerotel welcome FDA regulation of mobile medical apps. We believe that there is a real need to assure the stability, reliability and quality of all mHealth solutions so patients won't face any risk.
Aerotel Medical Systems was awarded by Connected World Magazine the prestigious gold Value Chain Award in the home health category.
Aerotel received the award together for the company's e-CliniQ system and the Connect-CELL telehealth homecare hub. The company was nominated together with its partner Cinterion, the global leader in cellular machine-to-machine (M2M) communication and a Gemalto company.
Connected World Magazine’s Value Chain Awards honor the most successful corporate adopters of M2M technology and the solution providers that make their success possible.
“Aerotel and its partner Cinterion were honored for using M2M technology to enhance quality of life for patients with chronic conditions by increasing access to doctors and care givers,” said Peggy Smedley, editorial director and publisher of Connected World. “Connect-CELL helps cut costs while improving quality of care and it also highlights the transformative power of M2M technology in solving global healthcare challenges.”
"The Connect-CELL hub is part of Aerotel's e-CliniQ system, which is one of the most cost-effective home telehealth solutions available today with proven clinical and economical benefits,” said Ofer Atzmon, Aerotel Medical Systems vice president for business development and marketing. "With Connect-CELL, caregivers can remotely see when a patient is in trouble and respond immediately for increased peace of mind and convenience.”
“Aerotel’s Connect-CELL homecare hub uses the latest Cinterion M2M technology to address the urgent need for solutions that reduce spending while improving quality of service for the growing ageing population,” commented Norbert Muhrer, CEO of Cinterion. “The use of Connect-CELL has already proven to reduce hospitalization costs by up to 30 percent.”
