SimplyHome Now Offers FDA Approved Wireless Telehealth Devices

SimplyHome leads the industry with FDA approved telehealth devices (used to monitor blood pressure, pulse, blood oxygen levels, glucose and weight) that guarantee patient data is securely transmitted to ensure proper treatment.

Asheville, N.C.

SimplyHome is now introducing an FDA approved telehealth product suite in preparation for an FDA rule that will be finalized this October. The rule states that IT companies will be required to register health care hardware and software that transfers, stores, converts or displays health care data.

Some devices that have not been FDA approved, but are being used to transfer patient FDAdata, present a potential risk to patients if they do not work as intended. For example, if the wrong reading is transferred to a website for a doctor to view, the doctor could potentially prescribe the wrong medication or dosage to the patient. There are several telehealth options available right now on the market but not all of them are FDA approved.

“The FDA approval represents a level of scrutiny so a customer can be confident that they are using a product of the highest quality possible,” says Jason Ray, SimplyHome VP of Business Development.

SimplyHome uses the term “telehealth” when referring to tools they offer used to remotely monitor blood pressure, pulse, blood oxygen levels, glucose and weight. Each reading is taken and then wirelessly transmitted using bluetooth to a base station that collects the data and then sends each reading to a confidential and personalized website.  Then, after customizing an individual’s profile, family, medical personnel, and caregivers can receive instant notifications if health parameters are in a range of concern.

The benefits of telehealth technology are:

  • Promote preventative care
  • Support overall wellness
  • Cut down on hospital readmissions

Each device used to test blood pressure, pulse, blood oxygen levels, glucose and weight must be individually approved by the FDA. Not only that, but all of those readings need to be transported to a central device so those readings can be logged to view trending activity, pin-point potential problems and set up alert rules and that device must be FDA approved as well. Some companies have built their own portal or base station to collect this data, but have not gone through the FDA approval process yet.MA105_angle-OEM device collage_v6_flat

The United States Food and Drug Administration (FDA) is the federal governmental agency charged with protecting the health and welfare of the American public through the regulation of food, drugs and medical devices. When a product is FDA approved, it means that EVERY aspect or component of the device, including any claim found on the device, has been scientifically proven to be valid, safe and effective. It also includes a thorough FDA inspection of the laboratory and facilities, in addition to intense review of the validity of the computer system’s hardware and software. It is against the law for any product or service to claim it is FDA approved when it is not.

When equipment or software is intended for use in the diagnosis or treatment of a disease or other condition, the FDA considers the equipment or software to be a medical device. The FDA also regulates the software used in telehealth systems.

“We feel a responsibility as a company to make sure we are providing solutions that meet FDA requirements so customers can rest assure that their purchases will meet regulatory requirement long before they are being enforced, ” says Jason Ray, SimplyHome VP of Business Development.

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Elder Abuse Awareness Month

“With Gov. Pat McCrory’s declaration of June as Elder Abuse Awareness Month in North Carolina and World Elder Abuse Awareness Day on June 15, it is important to raise awareness within the local community in order to make an impact not only in the state but also the nation.

“While people may recognize signs of physical abuse, it is often mental and financial abuse that occurs and goes undetected,” says Amy Natt, a certified geriatric care manager and owner of Aging Outreach Services, a full-service elder care firm with offices in Southern Pines and Cary.

The latest U. S. Census statistics show approximately 14 million U.S. adults age 65 and older and 19 million U.S adults aged 18 to 64 have a disability, which increases their susceptibility to abuse. Elder abuse and neglect occurs when a family member, caregiver or individual trusted by the elder, intentionally creates risk or does harm to that elder.

With the more than 10,000 baby  boomers turning age 65 everyday, this group is the largest growing segment of the population making the need to combat elder abuse and raise awareness even greater. By 2050, U.S. Census data predicts there will be more than 19 million age 85 or older.

With a growing population of elders, it is often impossible to have exact numbers of elder abuse reports because many go unreported; however, the latest studies have revealed that females elders are more likely to be abused than their male counterparts and that the older the elders are, the more likely they are to be abused. Research has also shown that those with dementia or Alzheimer’s disease are at a greater risk of being abused. Older adults may not report the abuse because of fear of retaliation or because they are embarrassed, or because they lack the physical or cognitive abilities to do so.

The impact of elder abuse impacts not only the elder with additional medical costs or personal financial losses but also increased expenditures by county, state and federal entitlement programs.

“An alarming number of scams now target older adults with false claims and promises, hoping to tap their financial resources,” says Natt. “Sadly, we have seen many cases of abuse that occur within a family. A lack of resources, caregiver stress and fractured relationships can contribute to this as well as a history of past abuse.”

With raised awareness through education and initiatives like Elder Abuse Awareness Month, elders can be safer in their communities. “Abuse occurs in many forms, and as a society, we need to have an awareness and become advocates for our elder population,” says Natt. “After all, we are all aging and someday, it may be you who needs a voice.”" For more information visit Aging Outreach Services