Experts say FDA likely will need to consider whether and how to regulate medical smartphone applications as the programs become increasingly popular among providers, Scientific American reports.

About 1,500 smartphone applications target health care providers, and about 81% of physicians will have smartphones by 2012, according to a new report. Although FDA has the authority to regulate certain medical devices, no guidelines indicate whether the agency can oversee the accuracy and quality of smartphone applications and other health information technology (IT) tools.

Today there is widespread interest in new technology among medical residents, according to a professor of medical informatics at Columbia University. He notes that certain apps may have the potential to save “enormous” amounts of health care dollars. One program, for example, may prevent unnecessary ED admissions by notifying physicians when their patients wish to visit the ED.

Noting that FDA’s role in such health IT tools is evolving, officials say the agency is considering various degrees of oversight for the health IT industry:

 

• The most lax approach would make manufacturers responsible for addressing safety concerns and reporting problems to FDA;
   
• The middle-ground approach would require manufacturers to follow FDA guidelines on quality and consistency; and
   
• The most intensive approach would require FDA to conduct pre-market safety and efficacy reviews for health IT tools.
   

IPAD A TIPPING POINT?
Meanwhile, several health care organizations are testing uses for Apple’s iPad device, which has the potential to “usher in billions of dollars in savings,” according to a corporate director at Partners HealthCare. The CIO at Harvard Medical School says that the relatively low cost and easy-to-learn functionality of the iPad could drive widespread adoption among health care professionals and pave the way for greater use of electronic health records.

Proponents of the iPad praise its light weight, speed and battery life, as well as its large screen, which is more conducive to reading X-rays and MRIs than the iPhone. However, critics say the iPad is fragile, has a small keyboard and does not contain adequate privacy protections (Wapner, Scientific American, 4/12; White, Washington Post “The Big Money,”)