FDA and telehealth

Digital Health – FDA

Dec 7, 2017 – The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devicestelehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies,; Improve …

Mobile Medical Applications – FDA

Jump to Does the FDA regulate mobile devices and mobile app stores? – FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers.FDA’s …

Press Announcements > FDA approves first telehealth option to …

Nov 17, 2017 – “Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to …

FDA regulates telemedicine on smart phones : CAMLAW …

http://www.camlawblog.com › New Regulation

As one law firm explains in Is Your Smart Phone An FDA-Regulated Medical Device? – FDA Announces Plans To Regulate “Mobile Medical Applications:”. The FDA views handheld computers loaded with these apps to be medical “devices” subject to extensive FDA regulation. The FDA’s draft guidance sets out its current …

FDA clears telehealth option to remotely program cochlear implants …

Nov 27, 2017 – FDA regulations · Telehealth · Mobile technology. print reprint. The Food and Drug Administration has approved the first telehealth option to remotely program electronic hearing devicescalled cochlear implants, rather than having audiologists make programming adjustments to them at specialized centers …

Thirty-six connected health apps and devices the FDA cleared in 2016 …

Dec 30, 2016 – While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software … Medtronic received FDA clearance for its AVIVO Mobile Patient Management System, which continuously measures, records and periodically transmits data for …

FDA Establishes New Digital Health Unit « Center for Telehealth and e …

ctel.org › Telehealth Buzz

May 12, 2017 – On the new unit’s agenda: topics like wireless medical devicesmobile apps,telemedicine, software as a medical device, and interoperability, among others. The overall focus will be on bringing “regulatory clarity” to the relatively new and continually evolving industry. In particular, theFDA is seeking to …

FDA OKs Telemedicine Platform for Programming Cochlear Implants

Nov 20, 2017 – The announcement continues a string of FDA approvals over the past month of innovative telemedicine and mHealth devices. This one is designed to help the 58,000 adults and 38,000 children who have received cochlear implants since 2012. The implant is designed to electrically stimulate the nerves …

Remote Patient Monitoring Technologies Addressed by FDA

Jul 31, 2015 – Among the many mobile apps and devices that the FDA does consider under the definition of a medical device but does not pose any serious danger to patients … Another remote patient monitoring solution that’s made an impact is Authentidate’s telemedicine service, which has helped monitor the health of …

Why Mobile Health Applications Require FDA Regulation

Aug 5, 2015 – August 05, 2015 – If a medical device like a pacemaker was to be installed through surgery and hadn’t been thoroughly vetted by the proper agency, what patient would ever allow their doctor to go through with the surgery? It’s likely no such patient exists and healthcare advocates expect all medical …

Prioritize health prevention forum on Aug 23 in Los Altos

You are all invited in Los Altos on Aug 23 for health prevention forum. Contact Connie at motherhealth@gmail.com

630 pm at First Republic Bank, 400 S. San Antonio Rd. Los Altos CA 94022



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Smart caregivers using smart health tools, science and high technologies

Can we create health tools to help monitor and be proactive with the health of our current patients with full engagement from all health care team? There are high tech tools today that is being developed to help our patients, measuring biometrics, behaviours and biology. A smart caregiver using health tools, health data, health science and health care team can be very helpful in preventing emergencies.

At Motherhealth – bay area caregivers , we educate and train caregivers and families in ensuring to be proactive about the health of the people we serve.

One of our senior client was visited by a nurse who measured his body temp (anally) and with feedback from the caregiver regarding his body responses the night before (pain level, anxiety, and other feedback from his biology and other health care data) was able to determine to take the patient to the ER for antibiotics and be monitored by the doctor for more health data.

The future is looking at smart and empowered care teams from doctors, health consumers and caregivers to take an important role in monitoring and impacting better health outcomes.

While more money is used to create more clinical trials, high technology tools and collaboration, the volume of research and tools are increasing in number every day that the health consumer has to proactively be part of the equation in defining the future of health care with less waste and reduced chronic care costs.

Lessons: Health consumers and families are engaged about their health outcomes. Health tools are used in combination with human touch.

In transporting the patient from home to bay area hospital where a gourney is used and not a wheelchair without incurring the cost of the emergency transport, google non-emergency transport and call the ER of the hospital of your arrival time. And maybe transfer the patient from gourney to wheel chair once you arrive in the hospital. We wish that the doctor can be connected online, and the nurse can administer the antiobiotics IV. We are not in this mode yet, that we have to transport patients for pneumonia and UTI when a home health solution can be implemented with telemedicine and a nurse practitioner communicating to a visiting home health nurse. This is still using only a smart phone and common nursing tools. We have not used the high tech tools that is envisioned and the greatest in the preventive and monitoring health care space.

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Using Blockchain to move secured patient data

By Megan Moltini

THIS MORNING, SENATE Republicans moved Rep. Tom Price one step closer to the highest office of public health, rolling over a Democratic boycott in the finance committee and advancing his confirmation as Secretary of Health and Human Services to a full Senate vote. But while Dems still have plenty of unanswered questions about the ethics of Price’s financial dealings, health care communities are already thinking about how he might lead the agency into the future. During a confirmation hearing last Tuesday, Price came out against electronic health records, the digital histories patients make every time they see their doctor or go to the hospital. “We’ve turned physicians into data entry clerks,” he said, arguing that the burdensome recording systems need an overhaul.

He may not be wrong. For almost a decade, hospitals have been waiting for EHRs to usher in a shiny new era of standardization and high quality health care. But while federal laws and incentive programs have made health care data more accessible, the vast majority of hospital systems still can’t easily (or safely) share their data. As a result, doctors are spending more time typing than talking to patients. And it’s wearing on them; physician burnouts jumped from 45 to 54 percent between 2011 and 2014,according to a Mayo Clinic study. The number one thing those doctors would change? Streamlining the EHR process. And the most popular strategy circulating among health care technologists is blockchain.

For a refresher, blockchain is the distributed accounting platform that makes cryptocurrencies like bitcoin possible.But wait, you say! Isn’t that like what the dark internet uses to exchange drugs and cyber weapons and stuff? I don’t want that near my medical records!

Breathe. OK. While blockchain is most best known for powering bitcoin, it’s really a generic tool to keep secure data in a distributed, encrypted ledger—and control who has access to that ledger. Rather than having one central administrator that acts as a gatekeeper to data—a list of digital transactions—there’s one shared ledger, but it’s spread across a network of synchronized, replicated databases visible to anyone with access. Which gives it unprecedented security benefits. Hacking one block in the chain is impossible without simultaneously hacking every other block in the chain’s chronology.

This makes blockchain incredibly appealing to the doctors and hospitals that need secure access to a patient’s entire health history. “Now is probably the right time in our history to take a fresh approach to data sharing in health care,” says John Halamka, chief information officer at Boston-based Beth Israel Deaconess Medical Center. For the past decade, Halamka has been responsible for health care data standards in the US, first under the Bush and then the Obama administration. He sees a blockchain-underwritten future in which a patient’s every health care interaction goes into a ledger every provider can see. “The EHRs may be very different and come from lots of different places,” Halamka says, “but the ledger itself is standardized.”

Every time a digital transaction takes place, bits of code group it into an encrypted block with other transactions happening at the same time. For bitcoin, this would be a flurry of buying and selling. For EHRs, it might be all the things that happen to you on a doctor’s visit (blood work, a new prescription, maybe some X-rays). Then people validate the transactions—in health care, likely a physician or pharmacist trusted with an access key. Then the software timestamps each validated block and adds it to a chain of older blocks, in chronological order. The sequence shows every transaction made in the history of that ledger, whether it be bitcoin sales or a knee replacement procedure. Get it? It’s a chain of blocks. Blockchain.

Halamka gives a simple example: prescriptions. Say that one medical record shows a patient takes aspirin. In another it says they’re taking Tylenol. Maybe another says they’re on Motrin and Lipitor. The problem today is that each EHR is only a snapshot; it doesn’t necessarily tell the doctor what the patient is taking right now. But with blockchain, each prescription is like a deposit, and when doctor discontinues a medication, they take a withdrawal. Looking at a blockchain, a doctor wouldn’t have to comb through all the deposits and withdrawals—they would just see the balance.

And crucially for patient privacy and security, hospitals and pharmacies don’t have to send data back and forth to see it. They just all have to point to the same common ledger.

So does it work? For prescriptions, at least, initial results are promising. Halamka recently teamed up with researchers at the MIT Media Lab to test a blockchain application pilot called MedRec. Team-lead Ariel Ekblaw put the authentication log to work at Beth Israel, tracking six months of inpatient and outpatient medication data with MedRec code deployed through virtual machines at MIT. They recorded blood work records, vaccination history, prescriptions, and other therapeutic treatments, simulating data exchange between institutions by using two different databases within Beth Israel. The results were so positive that Ekblaw is already starting to plan more pilots with larger networks of hospitals.

MedRec is still an early prototype, not ready for widescale deployment any time soon. But government health technologists see its promise. Last year, the Office of the National Coordinator for Health Information Technology—the part of HHS that helps health care providers adjust to new, digital paradigms—held a blockchain competition. MedRec was one of the 15 winners, along with entries from major health care players like The Mayo Clinic and insurance giant, Humana.  And in January, the Food and Drug Administration announced a research partnership with IBM Watson to find ways to safely share data from EHRs, clinical trials, genetic sequencing, and even mobile wearables using the blockchain approach. The technology is still in its infancy when it comes to health care applications, but in a recent poll of health care executives, IBM found that 16 percent of them intend to implement some sort of blockchain solutions by the end of this year.

Whether or not a Price-led HHS will jump on the blockchain bandwagon remains to be seen. The 21st Century Cures Act, signed into law in December, should push some of these interoperability issues to the top of the agency’s agenda. But officials at the ONC say nothing is happening until the new administration reviews the finer points of the law. Price’s office did not respond to a request for comment.

Halamka says no one from Trump’s team has yet contacted him, but that Price’s record on EHR leaves open the door for a blockchain future. “He likes the ability to see a patient’s longitudinal history and he doesn’t like the burdens on physicians,” he says. In a way, blockchain is the best kind of distribution of labor.

Editor’s Note 12:10 Eastern: This story has been updated with the results of a Senate committee vote, following a rules suspension by GOP lawmakers


Health Data and patient-provider engagement using technology

Recent surveys from the Pew Research Center indicate that a majority of U.S. adults use technology to engage in their health care:

  • 63% of adult cell phone owners now use their phones to go online, a figure that has doubled since 2009. In addition, 34% of these cell internet users say that most of their online use is via cell phone. That means 21% of all adult cell phone owners—about 1 in 5—now do the majority of their online browsing via mobile phone, not another device such as a desktop or laptop computer.
  • 69% of U.S. adults track a health indicator like weight, diet, exercise routine, or symptom. Of those, half track “in their heads,” one-third keep notes on paper, and one in five use technology to keep tabs on their health status.

  • 35% of U.S. adults have gone online to figure out a medical condition; of these, half followed up with a visit to a medical professional.

Even with this activity, other reports reveal a dramatic gap between what consumers want and what they actually experience.

  • 80% of Americans who have access to the information in their electronic health record (EHR) use it, and a full two-thirds of those who don’t yet have electronic access say they want it.3
  • 41% of U.S. consumers would be willing to switch doctors to gain online access to their own electronic medical records.

  • Only about 20% of U.S. adults currently have access to their medical records online.5

Join , order your HELO Worldgn fitness tracker and share it with others to earn 10-20%:


More health data than FitBit and Apple Watch! Gain more patient if you are a health provider! Delight families to monitor their health at home and anywhere.

Email Connie at motherhealth@gmail.com for more info.