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 The FDA’s draft guidance sets out its current …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 …

Home health monitoring with Bluetooth connection

Motherhealth is now a distributor of home health products from andmedical.  Email motherhealth@gmail.com for products (auto blood pressure monitor with Bluetooth data output – Continua certified ) you can select from http://www.andonline site below, add personalize health coaching and supplementation from http://www.clubalthea.pxproducts.com .



Corporations and hospitals can also be served with personalize nutrition protocols and home health monitoring products.



What kind of health care can help reduce or prevent systemic health issues one person at a time?

The health consumer is connected to a system comprising of engaged health care team, health education, holistic healing ways and preventive health approaches, digitally connected for real time monitoring and use of latest health IT technologies, and approach to continuity of care that is patient focused.

Health care team and system must identify systemic health issues together with the patient. The patient knows and is educated and communicates to the health care teams who responds quickly to avoid emergencies, be it on the phone, email or online meeting/video teleconferencing.

Use of more or less gadget helps but the patient must be surrounded by supportive health care team who can monitor any changes to health and take action.

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Email motherhealth@gmail.com of your suggestions on how we can help reduce or prevent systemic health issues one person at a time.

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Why invest $1500 for complete DNA sequence before cancer or chronic disease appears

Most cancers are detected during the last stage (neuroendocrine cancer, lung cancer, breast cancer) and even with the use of immunotherapeutics and precision medicine, doctors agree that with Molecular Intelligence results physicians are able to extend life for cancer patients by one year only.

When my father had stage 4 lung cancer, he said that the pain is like in hell while he is still living on earth. He lived for 9 months, from the 3 months that the doctor suggested.

If you know anyone , friend or family member who died of cancer, would you like to arm yourself with knowledge that can be used by clinicians and yourself in preventing a chronic disease or cancer to appear 20 years from now?

Motherhealth understands that genomics is driving the development of precision medicine. It partnered with a molecular genetic lab in Davis, California and genetic counselors/scientists are welcome to join to help find actionable health data and insights early from the health information derived from the DNA seequence test.

We do not want to be in a rush to extend life for another year when we can live a quality life in next 20 years knowing our genetic limitations and triggers.

  • There is no need to wait or find a clinical trial. All health consumers are welcome to join.
  • We can utilize genomic companies who can provide analytics and data insights from your genomic data aside from the bio-informatics and genetic counselors/scientists that are accessible to you.
  • You can have a greater impact on how you lead your life free from health issues as you now have a baseline of your genetic data.
  • We now know that same medicine, different genes have different effects (AIDS medicine, allergy medicine, anesthetics, antibiotics, antidepressants, asthma medicine, cancer medicine, heart medications, pain killers, seizure medicines, etc)
  • Only big hospitals and those who can afford cancer therapy are able to fully use precision medicine during the last year of patients’ lives.

Join 25,000 people in helping redefine health with health concierge and precision medicine. For $1500, you get your complete DNA sequence and free health concierge from Motherhealth.

All doctors and families are invited to avail of this complete DNA sequence tests. Email motherhealth@gmail.com for more info.


For those looking for clinical trials, check out


For data analytics from genomic data, check out http://www.genospace.com/




Precision medicine: lessons learned

By Connie Dello Buono , motherhealth@gmail.com

I learned many care practices/protocols/collaborations and advance health IT and medicines in the area of precision medicine during the last conference.

FDA (Health Insurance companies and FDA are not present in the conference)

  • Regulations around cloud and internet are onerous.
  • Regulations and health insurance companies not aligned to ensure pharmacogenetic tests is a standard of care for all doctors at a reasonable costs for doctors, labs, health consumers and health insurance companies
  • Real problem: International, privacy rules are not the same


Collaboration among bio-pharma, cancer organizations and life science centers, hospitals and clinicians in the area of precision medicine is starting to form during the last two years to better understand cancer related health data in clinical space.

  • Precision medicine must use health data insights with actionable data points.
  • Plural anecdotes does not equal good data.
  • From Clinical outcomes to value outcomes , which is not the present scenario.
  • We have to scale the big data and derive health data insights. How?
  • There is a gap in health care practice, in balancing costs, tribal fashion of clinical practice ; ~80% softer, inferential, tribal
  • Curated health data to clinical decision is not translated.
  • Data warehouse to data mart to data cube for consumer oriented data, curated and reduced processing and search.  New, faster data access: score atomically from one metadata ; one single copy of data and apply link to it for easy access.
  • Complete DNA sequencing allows  discovery of new biomarkers based on output DNA data where utilized data ; 95% , shown in 5 continental population, to shown complex disease, 95% of casual variants identified by GWAS are multi-ethnic

Disease phenotypes

  • Disease phenotypes in different ethnic population ; statistical significance higher in 5 continental population
  • Strong evidence for clinical associations, to establish new functionalities
  • 22,483 variants known clinical associations

Individual protocol

  1. Pathogenic annotated GSA variant
  2. Annotate/cross reference clinvar
  3. Confirm clinical lab criteria
  4. Based on evidence report


  • Application areas: sample stratification and QC, early detection and intervention, participant selection for clinical trials, biomarker discovery (drug target ID)
  • Sample stratification and QC: population of increasing sample size, use SNP variance, epigenetics, gen or physical traits,
  • Epidemiology: 1 out of 5 with risk variance has kidney failure
  • Early detection: 70% present in African americans, a protective mutation against __ disease
  • Intervention: genetic counseling from test results for lifestyle modifications
  • Wilson Disease: gene ATP7B; high in Japan and Slovenia; body retains too much copper ; deposited in liver; undiagnosed organ failure to death
  • Warfarin Treatment: based on genetic profile, tailor dose
  • Biomarker discovery: 7000 SNPs are associated with 400 disease

Precision medicine with select hospitals for cancer patients, targeted based on DNA sequence and drugs

Contradiction of Precision Medicine Drugs

860 billion interactions in a single cell each day, 210 cells types and 78 organs and 100-300 Trillion microbes.

Issues with clinical data:

  1. Randomized controlled clinical trial: too expensive, too long
  2. Existing data sources: very valuable with many data insights; not structured; not specific to a patient cohort;
  3. Registries; traditional site-based; track patients over time; data mining to search for particular study data; very expensive; longer time to collect; more patient-centered;

Data scientists:

  • Give patients service, manage their medical records, organize and distribute them among their doctors
  • Structure and normalize patient data
  • Give patient a timeline of their health information
  • Together with other clinicians and doctors, provide data insights and actionable health data


Important considerations for a successful precision medicine standard of care

  • Institutions: Collaboration between hospitals, doctors, labs for complete DNA sequence and bio-pharma allowed the delivery of precision medicine
  • Doctors: Alignment of doctors with patient and his/her care team in implementation of precision medicine
  • Legacy system: Providing care teams transparent access to array of precision medicine from legacy systems
  • Data Science: Allow over-ride in variance matching with whole genome variants and cancer drugs
  • Clinical operations have access to wide array of precision medicine
  • Actionable results: stripping raw data to arrive at actionable results from data , using pattern generation

    In genomics: See the patient in context.

  • Data Fidelity: Clinician reviews raw data from feedback loop.  Change workflow routine on data collection, use of natural Language processing, SW solutions around data mapping, human curation of data elements
  • Consolidate databases:
    1. No clear annotated database for easy data mining; we reference back to the original raw data; which one to choose; drill down to clinical database evidence
    2. Updating DB and having the latest data

Other notes

  • Confidentiality of data: use an army of lawyers to maintain privacy of all (institution and consumers); finding balance enough liquidity, shareable while still conforming with regulatory environment
  • Real problem: International, privacy rules are not the same
  • Regulations around cloud and internet are onerous.
  • How do you prioritize data? Laser focus on goals , increasing data capture with focus on data elements that will allow to fire a large number of health data measures as quality loop for clinicians
  • Identify to make positive change is in the standardization of care.
  • Achievable scaling costs, level of trusts/granularity/specificity

Big Data

  • N of millions ; characterize as fast as you can and then create your big data asset ; under the complexity, you derive data insights ; Millions of N = 1S

    Make informed clinical decision

How to nurture big data enterprise in clinical cancer space?

There is a coalition building to pool resource knowledge to leverage novel cancer insights for cancer care.  Institute of Medicine, of the national academes has a system to set into motion to be able to use emerging science, informatics to improve cancer care and reduce suffering.

What if we can bring all electronic health data into one space ; share health data that is not financially injurious but drives science into creation of clinical knowledge

  • This is true in clinical science where we can see from genotypes, with proper computing power and scientific rigor
  • There 7 molecular drivers (HER,etc) – drives cancer

For health care provider: Use knowledge base, oncology database, derive what truth is (pain model, care guideline, population at risk)

  • Only 3% of the population are entered into a clinical trial
  • Everyday patients tend to be older, less healthy and more diverse
  • We are treating a more skewed view of the population

Challenge: how do we disseminate knowledge into actionable points and how to make people keep up with exploding knowledge base

  • Our ability to analyze disease (to sequence genes) outstrips our ability to know what it means

New diagnostics, new care, cancer biomarkers

  • We need too learn from patients, take data from backend, not to increase the burden, to rationalize information from various sources into a common understanding as to how care is rendered into clinical outcomes into wide variety of care in the US, use of modern computing skills to mine data and get data insights; fearless collaboration; to change incentives on how to mine data insights; reward institutions and clinicians for contributing to a common knowledge source – health data insights

Join 25,000 people in helping redefine health with health concierge and precision medicine.