E-HEALTH - E-SANTE - PHARMAGEEK

Nathan E. Wineinger, Ph.D., a research scientist at Scripps Genomic Medicine discusses how mhealth data is moving towards big data at a rapid pace.

Mobile health (mHealth) technologies allow for the generation of intensive care unit medical information, literally, in the palm of your hand. A smart phone can be transformed into a mobile heart monitor to diagnose atrial fibrillation, and continuous glucose monitoring has revolutionized the way diabetics manage their blood sugar levels. The digitization of human health through noninvasive devices and sensors can provide meaningful measures of individual wellness outside of a clinical environment.

Mobile medical apps need to be regulated because patient safety is at risk when they are used to diagnose or treat a disease, said Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health at a Nov. 19 House Energy and Commerce Committee subcommittee on health hearing.

The FDA's regulation of software as a medical device is based on risk and function, Shuren told the panel, and the FDA treats devices that perform the same function the same way regardless of the platform on which it is used.

"It's not about the platform. It's about the function," said Shuren.

Software becomes a medical device through intended use and diagnosis of disease and conditions or treatment cure mitigation of disease, he said.

"All we are saying is, the functions, when they stay the same, treat them the same, because the impact and the risk to patients is the same," Shuren said. "Simply because they got smaller and I can pick it up and walk out of the room with it, doesn't change the risk to the patients. Why for that reason alone would we treat it differently?"

The FDA issued nonbinding guidance Sept. 25 with their plan of how to regulate mobile apps as medical devices.

If, for instance, an app illuminates an LED light, like prevalent flashlight apps do, the FDA wouldn't consider it a medical device. But if the developer labels and markets it as a light source for doctors to examine patients, the FDA would approach it as it would an ophthalmoscope, the guidance says.

But the FDA might not need that guidance if Congress passes a bill that's currently sitting in the House Energy and Commerce Committee.

The bill (H.R.3303) would amend the Food, Drug and Cosmetic Act to regulate medical software. It would establish three categories of software--clinical, health and medical--with the two former software types not subject to FDA regulation.

But Shuren told the subcommittee that the bill undermines the FDA's authority to assure the safety and effectiveness of high risk medical devices.

The FDA would no longer be able to regulate blood glucose meters and software that is used to analyze pap smear slides, Shuren said.

"It's very confusing to us what this actually accomplishes," he said.

Read more: http://www.fiercemobilegovernment.com/story/mobile-medical-apps-need-be-regulated-patient-safety-fda-official-tells-hou/2013-11-27

With the proliferation of smartphones and tablets, mobile technologies are quickly being adopted as a means to alleviate certain physician pain points and strengthen patient self-management. The recently released Meaningful Use Stage 2 objectives hold a larger focus on patient engagement, and mobile health holds promise as a key tool in helping organizations address these requirements. In fact, many of the engagement objectives that were optional in Stage 1 – such as patient reminders and education resources – are now required in Stage 2. Additionally, many of the Stage 2 rules reference the delivery of results directly to patients. 

In our conversation with Eula McKinney today, she talks with Lonnie Hirsch about:

- how traditional hospital and service line marketing is shifting.

 - how traditional hospital and service line marketing is shifting.

“The hospital marketing strategy now needs to take into account preventative, acute care and post acute organizations, because as an industry, we are now responsible for the full continuum of clinical care,” 

by Amanda Guerrero | shared from MedCityNewsIt used to be that a patient visiting the doctor’s office might come away with a drug prescription, care instructions for how and when to take their meds, and a paper handout explaining their condition or...

Mobile phones won't take on the role of doctors, but they will become more widely used in diagnosis and treatment, says Ashley Bolser

Monday afternoon in the Washington DC area, a panel of serious game developers moderated by fellow game developer and co-founder at Digitalmill, Ben Sawyer (@BenSawyer) addressed a packed room of mHealth Summit attendees looking to become educated...

Ford is developing a car seat capable of monitoring drivers’ ECG to provide real-time health information and alerts of imminent cardiovascular issues such as a heart attack or arrhythmias.

My comment=> The technology is evolving rapidly.  How this will compete with or integrate with mobile devices and wearable monitoring devices remains to be seen.  The auto industry has had reasonable commercial success integrateing technology for entertainement purposes and also new safety technologies.  This health monitoring approach seems like a commercial gimmick, but might help sell cars.  i can envision the marketing of the speeding car with tachometer and heart rate monitor displayed side by side.

Take Home: UMass Medical School and WPI have developed an app that can detect atrial fibrillation.  This moves connected and mobile health closer to reality.  The really important development with this approch might allow us to treat patients who have AF intermittently (paroxysmal) differently than we currently do.  Because we are worried about stroke, patietns now get blood thinners all the time because we are concerned that they will have recurrences without knowing about it.  With this technology, in the future, we might see validation of a strategy that allows use of blood thinners when patients are in AF only, sometimes called a pill in the pocket.