On Tuesday morning in San Diego, Dexcom — a provider of continuous glucose monitoring (CGM) solutions for patients with diabetes — announced that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System.
With wireless Bluetooth technology built into the device transmitter, the G5 Mobile CGM System “is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone.”
This technology, in short, frees users from the need to carry a separate receiver.
Posted in Healthcare, mHealth, Regulation
In June of 2014, the Maine Board of Licensure in Medicine released their guidelines in regard to telemedicine. While Maine’s approach to telemedicine is flexible and progressive, the original set of guidelines left a bit of gray area. For example, the words “in-person” and “face-to-face” were used interchangeably. While this may not be of consequence in many industries, the difference between the two is substantial in the world of telemedicine.
To clear up the confusion, new guidelines with revised wording have been put in place.
Posted in Regulation
It has been confirmed that the ICD-10 deadline will not be pushed back again. With just three months left before healthcare providers must make the transition from ICD-9 to ICD-10, many providers are finding that they are severely behind schedule.
ICD-10’s expanded codes are currently unavailable in ICD-9, and will have an impact on all areas of coding related to diagnosis and inpatient procedures—and will apply to all providers, not just Medicaid and Medicare providers.
The full transition and integration takes the average healthcare provider multiple months and numerous man hours to complete. Quite a few providers are now scrambling because they are severely behind schedule. An EHR solution, that many providers are turning to, are at the software solutions by iPatient Care. Their Integrated Practice Management and Patient Engagement Solutions are revolutionary, and designed specifically to streamline and map out the best course of action for the ICD-10 transition.
Posted in Organizations, Regulation, Technology
FDA clearance — it’s not easy to get, but when you manage to get it, it’s a major accomplishment and a critical component in modern healthcare tech marketing.
Sentrian, a Remote Patient Intelligence company, says it has received confirmation from the Food & Drug Administration that its Remote Patient Intelligence solution reportedly meets the definition of a “medical device” for which the FDA intends to exercise “Enforcement Discretion.”
The designation identifies medical devices that “are not subject to further FDA regulatory requirements at this time” and clears the way for Sentrian to immediately begin marketing its RPI solution broadly in the U.S.
Posted in mHealth news, Regulation, Smartphones
The following is a guest contributed post from Bonnie Cassidy, senior director of health information management (HIM) innovation for Nuance.
I used to tell my daughter the scary story that my dad used to tell my family about the “Boy Who Cried Wolf.” It is the story of a young man who liked to stir up drama with false rumors about a hungry wolf, so much so that when the townspeople were in actual danger, they didn’t believe him. While most of the health information technology (HIT) world was at the HIMSS15 convention last week, the Senate unanimously voted, 92-8, to repeal the sustainable growth rate (SGR) formula that adjusts Medicare payments to physicians and effectively put an end to a flawed formula for Medicare payments, as well as any ICD-10 implementation delays. For more than 20 years, and with three official delays, the industry has been crying wolf, but it now appears that the transition to ICD-10 will indeed occur on October 1, 2015.
Posted in Healthcare, Healthcare IT, Hospitals, Regulation
As more businesses move into the mobile health arena, there has been a greater need to improve communication between companies and the federal government.
Now the “Department of Health & Human Services (HHS) Office for Civil Rights (OCR) has pledged to work more closely with mobile health (mHealth) companies to ensure that HIPAA rules are being properly adhered to,” according to HealthITSecurity.
HIPAA, enacted in 1996, stands for Health Insurance Portability and Accountability Act. Its primary purpose is to make it easier for people to keep health insurance, protect the confidentiality and security of personal healthcare information, and help the healthcare industry control administrative costs.
Posted in Healthcare, Healthcare IT, Regulation
Medical professionals are smarting at the imposition of “meaningful use penalties” now kicking into gear.
A program of the U.S. government’s Centers for Medicare & Medicaid Services (CMS), the meaningful use provision was approved with the 2009 economic stimulus package. It called for health care providers who demonstrate meaningful use of certified electronic health records to qualify for Medicaid and Medicare incentive payments.
Now, CMS officials say the agency is sending letters to providers notifying them of a 1 percent reduction in Medicare payments for not meeting program criteria. In addition, EHR Intelligence has reported that more than 28,000 eligible professionals will receive a 2 percent reduction for failing to comply with electronic records mandates.
Posted in Healthcare, Regulation, Technology