New lifeline for the poor and underprivileged arrives via mobile health

When the White House and a coalition of health groups for mothers recently looked at ways to improve care for at-risk expectant mothers, their technology of choice was the cell phone. A high percentage of the targeted groups have access to mobile devices.

The Text4baby initiative sends free text messages with medical tips and reminders three times a week to pregnant women and young mothers.

“By using text messaging on cell phones, this partnership uses a technology that has already been widely adopted,” Aneesh Chopra, the White House chief technology officer, said in announcing the program Feb. 4. “Research shows that 90 percent of Americans have a mobile phone.”

Because of White House involvement, Text4baby is probably the most high-profile example of mobile health, known as MHealth. The program's success will likely bring more attention to a health information technology approach that has been in development for at least three years and is on the cusp of expanded federal regulation.

The MHealth buzzword is just starting to gain wider use. The industry is still in the embryonic stages, and its contours are not fully delineated. Although growing rapidly, it is drawing the attention of federal regulators. And that could alter its path of expansion and innovation.

MHealth is defined loosely as the use of mobile devices and wireless networks for the purpose of delivering health care or health-related information. Although some view it as a subcategory of telehealth, others note that telehealth has a long history with wired networks. MHealth is new and centers on wireless devices, mainly cell phones and smart phones.

One reason for the excitement about MHealth is its ability to quickly reach poor, developing countries and areas where Internet access is sparse but many residents have cell phones. Nearly 4 billion people worldwide had cell phones in 2008, according to an industry association.

The nonprofit Core Group is giving cell phones to community health workers in Malawi and Cameroon for use in maternal and child health care. A health worker can use the cell phone to contact medical help if a woman experiences an emergency during childbirth. “It is a simple application that is lifesaving,” said Ann Hendrix-Jenkins, Core’s partnership development director.

In the United States, more than 10,000 women have signed up for Text4baby since it started in February. It is sponsored by the National Healthy Mothers Healthy Babies Coalition, along with the White House, Health and Human Services Department, and health and telecommunications industry members.

Other popular MHealth applications in the Unites States include mobile personal health devices, such as blood pressure cuffs, that users can link to cell phones to transmit results. Text messaging can be used for lab results, prescription ordering and communication with physicians.

“I think MHealth will be big for systems that empower patients,” said Dr. Ted Eytan, a health IT blogger and medical director for delivery system operations improvement at the Permanente Federation.

Eytan is not alone in his optimism. The past year has seen the formation of the nonprofit MHealth Initiative and the United Nations Foundation’s MHealth Alliance. In February, the McKinsey & Co. consulting firm estimated global MHealth opportunities to be worth about $50 billion, including $20 billion in the United States.

Regulatory Target

The pace of MHealth innovation in recent months has reached a frenzy. In the next phase, growth might be slower but more realistic. That's because the Food and Drug Administration has started working with industry groups, including the Continua Health Alliance, to prepare a regulatory framework expected to cover many MHealth devices.

Will cell phones be regulated as medical devices? Chuck Parker, Continua executive director, said he doesn’t think so. “It goes to the intended use,” Parker said. If a cell phone is sold as a means of communication and it happens to be used for medical applications, that does not make it a medical device, he said.

Beyond cell phones, FDA is looking to network mobile medical devices, Parker added. “There is a creation of new devices we have not seen before. It is a system of systems, with four to five components to create a new medical use.”

Bradley Merrill Thompson, health care attorney at Epstein Becker Green, said MHealth companies should anticipate that FDA will expand its role. “It is health care, and people should not be surprised to see regulation,” he said.

But more rules could have a chilling effect on innovation, he added. “I expect FDA will discourage it some. There is a cost to complying with the FDA.”

Although Text4baby and Core Group are demonstrating quick gains in simple applications of MHealth, the future path is less certain. The next phase will be interesting to watch.