FCC, FDA Partner to Advance Mobile Health
The Federal Communications Commission (FCC) and the FDA announced a new partnership that promises to accelerate the development of wireless medical technology. Through close collaboration, the agencies hope to streamline the regulatory process for wireless health devices, thereby promoting innovation and increasing access to new medical technologies for all Americans.
“The area of mobile health is a new and very innovative area within health care and holds the promise of both cost reduction and improved outcomes,” said Mohit Kaushal, MD, MBA, FCC’s Digital Healthcare Director. “Our goal is to clarify and delineate the respective areas of expertise and jurisdiction between the agencies.”
In a 2-day conference held July 26 and 27, top officials from both organizations worked together to outline a set of common principles and determine efficient strategies for the regulation of wireless health devices going forward. FCC Chairman Julius Genachowski and FDA Commissioner Margaret Hamburg, MD, signed a joint statement confirming their commitment.
They also met with key stakeholders from the medical, telecommunications, and device manufacturing industries to examine the unique challenges of integrating broadband connectivity with personal medical devices. A product showcase highlighted the latest innovations in the field, such as remote monitoring systems to track heart function and blood glucose.
Investors considered the meeting an essential first step in bringing new products to the market, according to the West Wireless Health Institute, a medical research company focused on wireless technology.
“A clearer regulatory framework will only spur further experimentation and investment,” said Paul McCreadie of the health care technology investment firm Arboretum Ventures. “The twoday event held by the FCC and FDA is a great start to furthering the whole area of mobile health.”
Health IT, E-Prescribing Vital to Medication Adherence
Electronic prescribing is “the most critical prerequisite” for health IT (HIT) implementation, the National Association of Chain Drug Stores (NACDS) said in a recent statement.
Submitted July 20 as part of a Congressional hearing, the statement urged the House Ways and Means Committee’s Health Subcommittee to consider pharmacy’s role in its ongoing efforts to promote the adoption and meaningful use of electronic health records.
The paper also highlighted the mutually supportive relationship between medication therapy management and HIT—both systems that, when used together, could enhance each other and substantially reduce the costs of nonadherence.
“Pharmacy HIT systems assist pharmacy with providing critical patient care services, such as medication therapy management (MTM) and evaluation of patients adherence to prescribed drug therapy regimens, in addition to providing pharmacists with information on patients’ prescribed drugs, potential drug-to-drug interactions, and drug dosing,” NACDS wrote.
The hearing also offered the organization an opportunity to lobby for the inclusion of pharmacies in any federal grant- or incentive-based programs to fund widespread adoption of HIT. As veterans of e-prescribing and the most accessible health care providers, pharmacists are in a unique position to bring HIT to the front lines of patient care, according to NACDS.
Is Automation the Answer to REMS Compliance?
As the FDA continues to seek new ways to manage the risks of certain prescription drugs, one company is advocating a novel approach: harness the power of consumer technology to facilitate consistent, ongoing patient communication that meets the FDA’s guidelines for Risk Evaluation and Mitigation Strategies (REMS).
iReminder—a health care technology company that connects patients and providers through email, phone, and SMS text messaging—voiced its recommendation at an FDA public meeting on REMS, held July 27 to 28.
The company believes the FDA should consider using familiar automated technology, such as interactive voice response systems and automatic alerts by phone and email, to deliver crucial information to patients, prescribers, and pharmacies.
“We know from research on memory that 1 day after information is presented to them, people remember only 20% of what they learned,” said Jean Stecker, iReminder’s senior vice president. “Despite the collective best efforts of pharmaceutical manufacturers and the FDA to design readable and culturally appropriate medication guides, these guides are typically quickly discarded by patients.”
According to iReminder, an ideal REMS-compliant system would automate all elements of tracking and communication: patient reminders for refills and laboratory tests; alerts to prescribers and pharmacies when patients fail to comply with treatment, such as routine laboratory tests or refills; and distribution of electronic medication guides. It would also provide online access to any relevant documentation.
A whitepaper summarizing iReminder’s analysis is available at www.ireminder.com/whitepaper.php.