AcuteCare Telemedicine Blog

FDA, mHealth Regulations are on the Horizon

A battle is beginning to build between various stakeholders and investors in new medical mobile applications over the timing of the release of long-anticipated Federal Drug Administration (FDA) regulation of the medical app industry. A group of 100 organizations including medical trade associations and electronic health record product companies wrote to federal regulators recently, urging the need for slowing the course on mHealth regulation, particularly until a mandated federal workgroup finishes working on a report to guide Congress on the issue.

Brad Thompson, attorney for the mHealth Regulatory Coalition, the group working to prepare the report for Congress, submitted a letter to regulators the same week urging the release of mobile app regulations as soon as possible. Thompson, a member of the workgroup says he’s “pretty familiar with what that group is doing, and I don’t see publishing the FDA guidance as frustrating at all.”

Mobile app developers need regulations now in order to know if their product needs FDA approval. Without it, they could be breaking a federal statute

if they go to market before the regulation is released and may find that they will be undersold by competitors who do not seek FDA approval.

The dollar amount of investments awaiting federal guidance is significant and the risk is even greater.  The uncertainty over the guidelines which will ultimately determine whether some medical application need FDA approval before going to market is palpable for stakeholders who are reserving large amounts of capital pending the news.  As is often the case with governmental regulations, knowing is far better than not knowing in the eyes of many investors.

Medical applications for use with mobile devices are a very promising niche for those who are marketing medical services through telemedicine.  Mobile applications promises to expand and ease accessibility to chronic disease patients who currently are underserved, particularly when it comes to highly specialized medical care.

FDA officials have indicated that they are moving toward an October 2013 release of regulations.

New Technologies Improving Health Care

Much has been said and written about technology and its effects on the practice of medicine regarding how telemedicine and telehealth promises positive economic availability of health care going forth into the future.  As the doctor shortage and increase in the costs of medical services continue to front and center the debate, medical technology companies focus their resources on providing less expensive, faster and more efficient patient care.

To speed up and simplify the approval process of new medical devices, the Federal Drug Administration (FDA) recently formed the Medical Device Innovation Consortium (MDIC).  The organization seeks input from industry, government, and other nonprofit organizations and will prioritize the regulatory science needs of the medical device community and fund projects to streamline the process.  “By sharing and leveraging resources, MDIC may help the industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,” says Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Every year industry observers and media select their favorite technology trends that propose to have the most favorable impact on overall medical care costs, patient care quality and safety.  Here are just five of this year’s technologies that fit the criteria.

The Optical Scanner

Melanoma, the most deadly form of skin cancer, has always been impossible to diagnosis without an invasive surgical biopsy.  The MelaFind optical scanner is not for definitive diagnosis but rather to provide additional information a doctor can use in determining whether or not to order a biopsy.  The new device is manufactured by MELA Sciences and uses missile navigation technologies originally developed by the Department of Defense and scans the surface of suspicious lesions.  The data is collected and processed using heavy-duty algorithms and matched against a registry of 10,000 digital images of melanoma and skin disease.

Electronic Aspirin

A reliable, long-lasting treatment for the most severe form of headache, chronic Cluster Headache (CH), is lacking. CH has long been associated with the sphenopalatine ganglion (SPG), a sensory nerve bundle in the head. Blocking pain directly at the SPG has been an elusive goal. A technology under clinical investigation at Autonomic Technologies, Inc., is a patient-powered tool for blocking SPG signals at the first sign of a headache.  The system involves the permanent implant of a small nerve stimulating device in the upper gum on the side of the head normally affected by CH.   The lead tip of the implant connects with the SPG bundle, and when a patient senses the onset of a headache, he or she places a handheld remote controller on the cheek nearest the implant. The resulting signals stimulate the SPG nerves and block the pain-causing neurotransmitters.

Needle-Free Diabetes Care

Anyone who suffers from Diabetes has to deal with the constant need to draw blood for glucose testing, the need for daily insulin shots and the heightened risk of infection from all that pricking and poking.  Echo Therapeutics is developing technologies that would replace the poke with a patch.  The transdermal biosensor reads blood analytes through the skin without drawing blood. The technology involves a handheld electric-toothbrush-like device that removes just enough top-layer skin cells to put the patient’s blood chemistry within signal range of a patch-borne biosensor. The sensor collects one reading per minute and sends the data wirelessly to a remote monitor, triggering audible alarms when levels go out of the patient’s optimal range and tracking glucose levels over time.

Autonomous Navigation Robots 

Telemedicine is well established as a tool for triage and assessment in emergencies, but new medical robots are taking the process one step further.  With the capability to patrol hospital hallways on more routine rounds, checking on patients in different rooms and managing their individual charts and vital signs without direct human intervention these new robotic devices are improving routine health care to hospitalized patients.  One of these new devices, the RP-VITA Remote Presence Robot produced jointly by iRobot Corp. and InTouch Health is the first such autonomous navigation remote-presence robot to receive FDA clearance for hospital use. The device is a mobile cart with a two-way video screen and medical monitoring equipment, programmed to maneuver through the busy halls of a hospital.

The Sapien Valve

The Sapien trans catheter aortic valve is a life-saving alternative to open-heart surgery for patients who need new a new valve but can’t endure the rigors of the operation. Manufactured by Edwards Life Sciences, the Sapien valve is now finding its first use in U.S. heart centers where it is being limited only to the frailest patients. The Sapien is guided through the femoral artery by catheter from a small incision near the grown or rib cage. The valve material, made of bovine tissue, is attached to a stainless-steel stent, which is expanded by inflating a small balloon when correctly placed in the valve space. This new device and simpler procedure promises dramatically shorter hospitalizations and is bound to have a positive effect on the cost of care.

Medical industry leaders agree that today’s most desirable technologies, whether telemedical communications or Sci-Fi-gadgets, strike a balance between reducing the overall cost of medical care while increasing safety and survival rates among patients.   While not immune from controversy and push-back from both health care providers and patients alike, new technologies hold the greatest promise to bringing higher quality and more efficient and affordable health care to millions of people around the world.

Stroke Care Requires a Change in Behavior

More than 2 million brain cells die each minute during a stroke. Reducing the time from a patient’s arrival in the emergency room to the administration of the clot-busting agent tPA, the so-called “door to needle” time, is paramount. A major obstacle to treatment outside the direct influence of the physician is when individuals with stroke symptoms delay seeking treatment.

The public is not without knowledge of stroke. Multiple websites and sources help people recognize stroke symptoms. These include academic sites such as the Mayo Clinic, commercial sites like WebMD, and government resources from the NINDS (National Institute of Neurological Disorders and Stroke). Public service announcements have been used to improve the awareness of stroke symptoms. More importantly, the time sensitive nature of stroke treatment has been brought to the forefront as a focus since the 1990’s. Education does help; the percent of patients arriving to the ER within 24 hours of stroke onset nearly doubled following a 1992 campaign stressing the need for early treatment.

However, in 1996, following FDA approval of tPA use with a 3 hour time limit, the role of timeliness in stroke treatment became even more crucial. Whereas public awareness of stroke symptoms had improved, education campaigns had not sufficiently decreased the time to respond. Even today, many patients are still missing the benefits of immediate treatment with tPA. Education has achieved its goal, making the risks of stroke and the availability of treatment understood, but changing behavior is not as easy. The public is not unafraid of stroke; people may simply be too afraid of the diagnosis. Delays result from the inability to accept that a stroke is actually occurring. Furthermore, previous unfavorable experiences in receiving care or suboptimal outcomes can influence future behavior.

This concept is supported by data in patients with myocardial infarctions (heart attack) which suggest psychological factors may be at play. The extrapolation of this behavior to stroke is not difficult given the typical presentation of stroke is not painful and often not immediately disabling. Society must reinforce the immediate use of the 911 system and healthcare providers must endeavor to give every stroke event the best possible outcome. Otherwise, patients who “wait and see” if it is really going to become a problem suffer as brain cells die.