#mhs11 FDA regulations around medical devices and apps mHealth regulatory coalition recommendations

Notes from mhealth summit.
Today if you connect to a medical device you are a medical device.
Now everything is connected.
Medical device data is:
Storage,
Conversion, transfer,
Display.
Not:
Active patient monitoring
Device control
Modify
Analyze
Mobile medical apps guidelines. Three tier pyramid.
1. Connects to a medical device
2. Transforms the mobile device I'm to a medical device
3. algorithm that output a patient specific result
It is not:
Medical text books
Providing clinicians with training
General health and wellness apps
Automate general office operations
Generic aids eg. Word processor
Electronic health records

Manage weight = wellness
Manage obesity = disease
Latter is medical device
The middle group that is undetermined:
- automate common medical knowledge
- self manage their disease
- automate common clinicians diagnostic ad treatment tasks
The mHealth regulatory coalition proposes changes to FDA proposed rules for mobile medical apps.
This is what FDA proposed:
Type A - aid in the use of parent device. Class 1 device
Type B - extends intended use - same level as parent device
type C - created a new intended use - bass on new risk.
Framework needed more clarity
Near term solution:
Type A - general purpose - unregulated Type B- not reasonably expected to directly affect safety and effectiveness - class 1
Type C - changes fundamental intended use- based on new risk
Type D - regulated products that are not toe a-c. Same as connected device.
We need new classification regulations. Need to clearly define categories.
Propose software modularization - use standard desin principles to create functional independence and reduce inherent risk of discrete modules.
Other agencies like FAA have embraced modularization for regulatory purposes.
Consider evolution of technology. Redefine fda's original manufacturer definition:
1. Mobile medical app manufacturer
2. Mobile platform manufacturer
In 1. The distributor is excluded. Eg. ITunes apps store.
In 2. Component manufacturers are excluded. Their platform is produced with no intended use.
Alternative:
Medical device manufacturers are exactly that.
Don't regulate distributor and component manufacturer categories.
MRC suggests: 1. Promoting investment and innovation
2. Clarify scope of FDA jurisdiction
3. Recognize current approach is an intrusion on the practice of medicine.
4. Recognize global nature and harmonization of regulation
5. Create an mHealth division in CDRH
6. Define regulatory state of EHR and HIE. 7. Consider CDS software software separately (clinical decision support)
Mark Scrimshire
B: http://ekive.blogspot.com
....Sent from my iPhone

Posted via email from ekivemark: pre-blogspot

#mhs11 raj shah CEO of CTIS

Raj is managing chronic care through mobile.

100M Americans have 1 chronic disease.
MHealth value proposition: comfort, clinical, collaborative, convenience.

Mark Scrimshire
B: http://ekive.blogspot.com
....Sent from my iPhone

Posted via email from ekivemark: pre-blogspot

#MHS11 Open Standards for mHealth Interoperability in Severely Resource-Constrained Environments

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

Session 5

2:15–3:15 PM

Open Standards for mHealth Interoperability in Severely Resource-Constrained Environments
Many of the world’s funders of mHealth programs are interested in seeing international standards adopted by tools providers in order to expand the reach of programs they are currently supporting. To identify and decide on the appropriate standards is one of the key focus areas for the funders and implementers of national scale mHealth deployments. NetHope is undertaking a study for PEPFAR on this topic and they are interested in using the findings to initiate a broader discussion with industry stakeholders. Preliminary documentation will be published on HealthUnbound.org for review prior to this panel discussion.

Moderator
Fredrik Winsnes Healthcare Working Group Lead NetHope	Alice Borrelli Director Intel	Michael Gehron PEPFAR HIS Coordinator Deapartment of State	Jonathan Jackson CEO Dimagi, Inc.	Derek Ritz Principal ecGroup Inc.

Good News / Bad News.

- Good: Projects are proliferating

- Bad: Projects do not interoperate

Discussion group on mhealth alliance web site. This session is to start a discussion.

NetHope doing a study for Department of State in the use of open standards.

Michael Gehron: 

mHealth Apps are like piles of bottles of water rather than a reservoir

Info systems are developed as part of wider initiatives

Assistance is provided in an emergency setting that over rides long term needs.

Derek Ritz: 

Deliverable: A design Specification onhow selected interoperability standards may be adopted.

NO NEW STANDARDS!

Leverage and extend artefacts from MNCH Framework and active projects.

Use Case Story defined business need. Processes were defined using UML.

Use cases based on maternity community care event in Africa - A real requirement from an active project.

Check out HUB on mHealth Alliance. Provide feedback to design team.

Jonathan Jackson: 

Dimagi founded in 2002 at Harvard and MIT Media Lab. An Open Source software company.

Co-Developed national medical record system for Zambia Smartcare.

Co-founded: OpenROsa and JavaRosa, RapidSMS, CommCare, Coded in Country Initiative.

Tend to integrate more than interoperate.

See little demand for plug and play interoperability.

Little capacity to consume interoperability standards.

Better to focus on open and available data than standards

But... they still think standards are great.

Contracts should demand vendors provide one-click download of data. 

Facebook and Twitter do not follow standards but they are massively consumed. 

Alice Borrelli:

Personal Connected Health

www.continuaalliance.org

244 companies that have developed and adopted inter connected devices/systems.

40+ products certified.

Established 5 years ago and now starting to see solutions hit the market.

Personal Connected Healthcare can:

- reduce mortality: 35-56%

- hospitalization: -47%

- 6 day reduction in hospital stays

- 40-64% reduction in physician time performing checks.

Continua does not create standards.Depend on standards bodies to do so.

[This seems to be an odd statement since they are developing a standard for interoperability with EHR platforms.]

Singapore and Japan are adopting Continua as requirement for devices interoperating with national health record platforms.

Special pricing for non-profits and emerging market companies.

Generic interoperability can lead to us missing the problem. Trade-off between functionality and interoperability. 

Confusion between interoperability and the ability for applications to work together. e.g. Google Maps, Twitter, Facebook APIs.

Point to Point strategies perish with scale. 

Did this panel really address the issue of "Severely-resource constrained environments"

We need to make sure standards are Open and light weight. If not this will limit adoption in end user devices and increase their cost.

Simple, Lightweight, Open. That will make easy adoption. Simple on the Internet wins.

1 in 10 medical procedures result in an error that is medically adverse. Standards help us drive towards the levels seen in Aerospace and other high reliability industries.

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#MHS11 Basic Building Blocks of mHealth - Role of Patient Education and Monitoring of their medical compliance

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

Day 2: 

As patients better understand the use of applications for remote monitoring technologies, adoption of these applications may increase, bringing with it an increase in compliance. This panel discussion explores patient education in remote monitoring technologies, including education of specific disease states and how data is gathered and used.

 

Tuesday, December 6th
	11:15 AM–12:15 PM

Moderator

Michael O'Neil

Founder & CEO
GetWellNetwork

John de Souza
CEO
MedHelp International Inc.

Ryan McWhorter
President
Logistimo

Eric Schultz
CEO
QuantiaMD 

mHealth is an opportunity to change the game in patient engagement.

Eric Schultz - CEO QuantiaMD

We need practical ambition. People have too many distractions. Lack of compliance comes from multiple sources. 

Just more reminders don't work. You have to overcome the distractions. Media and life distractions, cognitive impairment.

Fight fire with Lorum Ipsum..... No wonder we lose. 

mHealth services not apps - not download and forget.

Apps - 6% of apps are downloaded and still used after 4 weeks.  There is an engagement issue.

Nurses and clinicians are a critical ally.

Educate them to be comfortable so they will prescribe the service/app to the patient.

Quantia's DAibetesIQ - described by iMedicalApps.com as Angry Birds: Diabetes Edition.

Ryan McWhorter - Logistimo

The intersection of patient and inventory management. 

Logistimo works off-grid in remote locations. Doesn't mean disconnected. Use classic mobile phones plus the cloud (GPRS or SMS). 

10,000 new HIV cases in Congo (due to rape)

PEP Kit needs to be received within a few days to be effective.

A project was developed to track episodes of rape, where a PEP Kit is located and whether a PEP Kit was administered.

Mobile Phones used to record data. Web used to manage.

Project is ready to go in January.

John de Souza - MedHelp

MedHelp - 12M monthly uniques.

longest established community.

Bring Data, Communities and Data together.

350 different communities.

mobile traffic is 30% of traffic. Set of mobile apps. 

Can also pull data from devices (eg. Withings scale)

Able to aggregate data across the country.

People want to communicate with their doctors. 

Doctors want an extract of PHR by specialty - addresses Doctor's liability concerns.

People don't care about data or devices - they care about their health. 

Q & A Session

What business models will stick?

John de Souza - if you have a bad solution making it mobile just makes it a mobile bad solution. 

You need to deliver real value. It needs to be compelling so you get continued use.

Employers need solutions. 

In place contextual sponsorship is a viable business model.

Convenience in a model that scales is financially viable with a low cost payment model.

Will clinicians be comfortable operating in a sponsor model.

Clinicians are more concerned in finding a viable patient education solution that gets the patient out of the office and doesn't take them more effort to operate. It needs to have good value for patient and not run counter to care guidelines. 

The danger in the USA is the slowness with which we move. We are and will be lagging what is happening in the rest of the world.

An unintended outcome is an increase in personal accountability. People are more engaged and motivated.

What are top 2 or 3 criteria to create a healthy angry birds:

1. Interoperability and integration of data

2. Health is not one dimensional

3. Don't make me work.

4. Speak to me in my own language. We need a simple vocabulary.

5. Fit the lifestyle 

6. Use indirection - use other actions to infer data.

We don't want to care for our health - we want to enjoy our life.

What barriers would the panelists like to remove:

Logistimo:

1. Reduce the number of decision makers/voices in international projects. no clear lead

2. Simplification

3. understandable language

MedHelp;

1. FDA guidance

2. HIPAA (used as a barrier to sharing)

Quantia:

1. Misalignment of incentives. Healthcare is done to patients as a disengaged bystanders. Align to outcomes.

Major companies have challenges understanding where things are in the supply chain. These are same challenges for health care. Coke and Tobacco are leading on the cutting edge. 

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#MHS11 Basic Building Blocks of mHealth - Role of Patient Education and Monitoring of their medical compliance

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

Day 2: 

As patients better understand the use of applications for remote monitoring technologies, adoption of these applications may increase, bringing with it an increase in compliance. This panel discussion explores patient education in remote monitoring technologies, including education of specific disease states and how data is gathered and used.

 

Tuesday, December 6th
	11:15 AM–12:15 PM

Moderator

Michael O'Neil

Founder & CEO
GetWellNetwork

John de Souza
CEO
MedHelp International Inc.

Ryan McWhorter
President
Logistimo

Eric Schultz
CEO
QuantiaMD 

mHealth is an opportunity to change the game in patient engagement.

Eric Schultz - CEO QuantiaMD

We need practical ambition. People have too many distractions. Lack of compliance comes from multiple sources. 

Just more reminders don't work. You have to overcome the distractions. Media and life distractions, cognitive impairment.

Fight fire with Lorum Ipsum..... No wonder we lose. 

mHealth services not apps - not download and forget.

Apps - 6% of apps are downloaded and still used after 4 weeks.  There is an engagement issue.

Nurses and clinicians are a critical ally.

Educate them to be comfortable so they will prescribe the service/app to the patient.

Quantia's DAibetesIQ - described by iMedicalApps.com as Angry Birds: Diabetes Edition.

Ryan McWhorter - Logistimo

The intersection of patient and inventory management. 

Logistimo works off-grid in remote locations. Doesn't mean disconnected. Use classic mobile phones plus the cloud (GPRS or SMS). 

10,000 new HIV cases in Congo (due to rape)

PEP Kit needs to be received within a few days to be effective.

A project was developed to track episodes of rape, where a PEP Kit is located and whether a PEP Kit was administered.

Mobile Phones used to record data. Web used to manage.

Project is ready to go in January.

John de Souza - MedHelp

MedHelp - 12M monthly uniques.

longest established community.

Bring Data, Communities and Data together.

350 different communities.

mobile traffic is 30% of traffic. Set of mobile apps. 

Can also pull data from devices (eg. Withings scale)

Able to aggregate data across the country.

People want to communicate with their doctors. 

Doctors want an extract of PHR by specialty - addresses Doctor's liability concerns.

People don't care about data or devices - they care about their health. 

Q & A Session

What business models will stick?

John de Souza - if you have a bad solution making it mobile just makes it a mobile bad solution. 

You need to deliver real value. It needs to be compelling so you get continued use.

Employers need solutions. 

In place contextual sponsorship is a viable business model.

Convenience in a model that scales is financially viable with a low cost payment model.

Will clinicians be comfortable operating in a sponsor model.

Clinicians are more concerned in finding a viable patient education solution that gets the patient out of the office and doesn't take them more effort to operate. It needs to have good value for patient and not run counter to care guidelines. 

The danger in the USA is the slowness with which we move. We are and will be lagging what is happening in the rest of the world.

An unintended outcome is an increase in personal accountability. People are more engaged and motivated.

What are top 2 or 3 criteria to create a healthy angry birds:

1. Interoperability and integration of data

2. Health is not one dimensional

3. Don't make me work.

4. Speak to me in my own language. We need a simple vocabulary.

5. Fit the lifestyle 

6. Use indirection - use other actions to infer data.

We don't want to care for our health - we want to enjoy our life.

What barriers would the panelists like to remove:

Logistimo:

1. Reduce the number of decision makers/voices in international projects. no clear lead

2. Simplification

3. understandable language

MedHelp;

1. FDA guidance

2. HIPAA (used as a barrier to sharing)

Quantia:

1. Misalignment of incentives. Healthcare is done to patients as a disengaged bystanders. Align to outcomes.

Major companies have challenges understanding where things are in the supply chain. These are same challenges for health care. Coke and Tobacco are leading on the cutting edge. 

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#mhs11 intel uses the BUT model

Intel: Business
Usage
Technology

Human centered design

Change management - teach business process change

Payment reform with value over volume

We don't want reimbursement for devices. Allow care to take place in least restrictive place possible consistent with quality outcomes.

Focus on people and workflow.

Clinic is not the only place that care can occur.

Mark Scrimshire
B: http://ekive.blogspot.com
....Sent from my iPhone

Posted via email from ekivemark: pre-blogspot

#MHS11 Day 2 Keynotes.

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

The day 2 Keynotes:  

Tuesday, December 6, 2011

9:30–10:00 AM — Morning Keynote

 

	John Stratton EVP & COO Verizon Wireless
	Dr. Regina M. Benjamin Surgeon General of the United States U.S. Department of Health & Human Services

 

Verizon's Stratton tells us we spent $1.1T on Chronic Disease in 2010 & cost $2.2T by 2020-12% of GDP & 7 of 10 deaths 

John Stratton points to the banks. Redefining customer relationship and reduced cost. HealthCare and Education are the last stand outs for change.

The Verizon approach to Digital Care Solutions:

- Mobile Clinicians

- Digital Care Management

- Virtual Care

- Independent Living

All built on 4G LTE.

Home based telemedicine is promising: 20% reduction in hospitalizations. 70% increased days between visits.

Mainly based on fixed wired line solutions. This needs to go mobile to give additional flexibility.

Leverage mobility and the cloud to transform chronic care management.

Building a scalable cloud-based digital care management platform.

I wonder how open Verizon's care management platform will be?

Integrate best of breed connected medical devices to track health goals.  Personalized care plans integrated in to daily life via all major smartphones.

I am wondering if Personalized Care Management is just the next consumer lock-in strategy?

Launching Mid-2012 focused around key chronic diseases. So they must be looking at providers buying smartphones for members. Or they will push consumers to switch to Verizon.

Verizon is partnering with Duke University: UPMC and Wellpoint in various pilots..

Verizon is pushing for reimbursement advocacy - allow mobile health tools to be charged for.

Good to push for inter-state credentialling to unleash telemedicine applications.

It will be interesting to compare AT&T's mHealth strategy to Verizon's. I suspect Verizon is further ahead in presenting a coherent mhealth strategy.

Next Up Dr. Regina Benjamin

The National Prevention Strategy.

Good health extends beyond health care. Change the way we think about health. An integrated approach that includes housing, food, road safety. preventive health services, empowered people and eliminate disparities.

Increase the number of americans who are healthy at every stage of life.

Prevention needs to be profitable and joyful.

Be more positive. Tell people what they CAN DO. - Stepping out with the Surgeon General. 

60 second Surgeon General Dance Break. - Let's encourage Radio stations to help people get active - e.g  by dancing.

There is now a Surgeon General App Challenge - 

1.Physical Activity

2. Healthy Eating

3. Integrated Health

Something easy and simple to use. Open until December 30th. Checkout SurgeonGeneral.gov.

The final word:  Remember to take your flu shot. 

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#MHS11 day 2 starts with discussion groups: EHR and mHealth

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

This is the start of day 2. I am attending one of the discussion groups ( http://www.mhealthsummit.org/program_morning.php ):

EHR and MHealth

Moderator: Abdul Shaikh, NCI

There are about 35 people with a diverse background attended this session.

We have the following representation:

- National Institutes of Health

- National Cancer Institute

- Consultants

- Academia

- Integrated Health Systems

- Software companies

- Mobile Startup companies

- Device Manufacturers

- Consultants

- NGOs

- Social Media

- Digital Agencies

- Physicians

- eHealth Government Initiative

- Europe

- Africa

- North America 

Fascinating discussion that touched on #RainbowButton initiative and Rainbowbutton.com and use of BlueButton data.

We need to be able to convert BlueButton data to a structured format for interoperability.

We need to capture Observations of Daily Living including patient preferences. These are not currently included in EHRs

Look at ONC and FDA for guidance on security guidance.

Who is doing anything on security toolkits for phones: Good and Better are two companies.

At a chip set level there are AES Encryption tools for phones. For transmission HTTPS is widely used for banking.

We should get government to declare our health data as an organ that we can donate upon our death. This just requires a redefinition of the scope of the organ donation clause when people apply for or renew their drivers license.

DirectProject.org got a shout out because people want to know how to move data between EMRs

GreenCDA - Simplified format for expressing data in CCR or C32. Progressing through standards process.

HDATA - Standard for transfer - RESTful. 

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#MHS11 ONC Town Hall Meeting on Consumer Engagement - Led by @Lygeia

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

http://www.mhealthsummit.org/program_special_onc.php

Special Session:

ONC TownHall Meeting on Consumer Engagement

Monday, December 5, 2011, 4:30–6:00 PM

Overview: Join Lygeia Ricciardi, Senior Advisor for Consumer e-Health at the Office of the National Coordinator for Health IT, and other members of ONC’s new Consumer e-Health program for a TownHall meeting to learn more about their strategy to boost consumer engagement in health via information technology.
ONC is making an unprecedented push toward promoting consumer access to and use of health information to better manage health and health care. Learn about the strategies and initiatives of this new program---the first-ever of its kind in the federal government. Additionally, find out how your organization can participate in a pledge program that offers a variety of benefits, including:

• An opportunity to help shape ONC’s consumer engagement strategy
• A forum to elevate issues and provide input on policy barriers/challenges that the federal government could help address
• Access to a community of peers to exchange best practices
• Input into the development of tools to educate and engage consumers
• Opportunities to network and partner with consumer organizations, provider organizations, and other stakeholder groups that share a similar vision

Lygeia Ricciardi leads the Office of the National Coordinator's Town Hall session on Consumer Engagement. 

1/3 of US Population is engaged in Health. 1/3 not engaged and 1/3 in the middle. 

We want people to have EFFECTIVE engagement. ie. When it matters.

Technology and Community changes are driving change. mHealth is part of that change.

ONC's role is to act as a catalyst for change.

ONC Strategic Approach

1. Access

2. Action

3. Attitude

Get access to information . Support the creation of tools and services that help consumers take actions. Attitude is about changing expectations.

1. Access to Information - The Pledge for Consumer Engagement in Health. Data Providers and Non-Data Holders.

HealthCamp Foundation has taken the Non-Data Holder Pledge.

More than 200 organizations have taken the pledge. This provides access to personal health information for more than 100 Million Americans.

Lygeia asked me to explain why HealthCa.mp Foundation took the Non-Data Holder Pledge. We have to put the Patient at the center. 

Fight Disassociated Patient Syndrome (Fight DPS!)

ONC is also involved with challenge.gov and is  putting up incentives and prizes to entrepreneurs to improve care transitions.

"Putting the I in Health IT"

ONC is looking for interesting and inspiring stories for people getting engaged in their care. 

Crowd sourced video contest and animated film to help create awareness around health care engagement.

ONC will use online media to develop a series of messages:

1. Healthcare is getting an upgrade via IT (build awareness)

2. Choose a provider who uses Health IT for your convenience and safety.

3. Get a copy of your own health info and check to make sure it is right.

4. Use e-health tools to engage in your health.

Frontier Issues:

1. Integration of patient generated data in to EHR's/Clinical Care

2. Use of Social media for Health

3. Enabling proxy access to personal data

4. Integrating information about costs and quality with clinical info to help consumers understand context of their decisions.

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#mhs11 The impact of cloud computing and online solutions on mHealth

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

Session 3

3:15–4:15 PM

The Impact of Cloud Computing and *Online Solutions on mHealth
Taking mHealth solutions to scale is an inevitable consequence of successful deployments. As public and private entities seek ways to optimize mHealth to help control costs and improve access to tools, information, and resources, they are are exploring the promise of cloud computing services. Organizations in highly regulated sectors such as healthcare must be prioritize security and other cloud issues when considering cloud computing solutions and online storage tools. This session approaches the mHealth cloud computing from a variety of perspectives including defining need, deployment, and evaluation.

Moderator

Halle Tecco

Founder & Managing Director 
Rock Health

Jesse Coleman
mHeallth Project Manager
BC Centre for Disease Control

Nadine Levick
Founder/Research Dir.
EMS Safety Foundation

Mehul Shah
EVP & CEO
CTIS, Inc.

Flaura Winston
Scientific Dirc. Professor
The Children's Hospital of Philadelphia / University of Pennsylvania 

Nadine Levick - iRescu

300,000 out of hospital cardiac arrests per year. Less than 25% receive CPR.

Developing a CPR/AED multimedia two-way support management system using smartphones.

Develop an App that avoids using medical jargon to teach use of AED.

Using Crowd sourcing to supplement database of AEDs.

Jesse Coleman - mHealth Content Management

Using a Content Management System to target Health Text messaging.

mHealth Content Management System - 

Ruby on Rails Platform

PHP Interface

SQL Database

Secure Web Interface

Mehul Shah - CEO of CTIS. Inc.

Current health trends is that 50% of US Population will have at least one chronic condition by 2025.

Innovative Intervention. 

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#MHS11 Medical Grade Wireless Testing: Accelerating Deployment in Health Care Settings through Test Environments

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

http://www.mhealthsummit.org/program_track_policy_2.php

Medical Grade Wireless Testing: Accelerating Deployment in Healthcare Settings through Test Environments 
Test beds play a promising role in advancing wireless innovation. To be successful, supportive policies and coordinated activity are needed across the private sector and government. Help shape the path forward.

Moderator

Gregory S. Walton

CIO
El Camino Hospital

Anura Fernando
Research Engineer
Underwriters Laboratories

David Hoglund
President
Integra Systems, Inc.

Ira Keltz
Deputy Chief - OET
FCC

Chris Riha
Clinical Engineer
Carilion Clinic 

Medical Grade usually means expensive.

Proprietary networks in health care are dead. The move is to use the IT Wired and Wireless Infrastructure.

But IT don't want the liability and risk of having medical devices on their IT network.

The typical Wireless LAN in a hospital has not been designed for medical device use.

Computing has entered every area in which we function: medicine, home, work...

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#MHS11 MHealthSummit Startup Health

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

StartUp Health: Bridging the Gap between Health & Wellness Entrepreneurs, Payers and Providers

http://www.mhealthsummit.org/program_special_startup.php

A panel moderated by: Steven Krein, Co-founder of StartUp Health

Peter Levin - CTO and Senior Advisor to the Secretary of Dept of Veteran Affairs - Promoter of the BlueButton 

Don Casey, CEO of West Wireless Health Institute & former Worldwide Chairman for Johnson & Johnson's comprehensive care group and member of the Company's Executive committee

Stephen Ondra, MD - Senior Policy Adviser of Health Affairs, Dept of Veteran Affairs.

BlueButton - What does it mean to Entrepreneurs.

Outcomes, Cost and Control model. BlueButton improves access, compliance. Real benefit is as a catalyst to move to patient centered care.

BlueButton is simple formatted Text File. (ASCII).

At the VA it tracks 17 items in a health record, including self-entered data. Now they are starting to include data from VISTA - The VA's EMR.

http://www.VA.GOV/Bluebutton

Two ideas that utilize the BlueButton File:

- Help physicians deliver information to patients

- Help patients manage their own care.

There is of course RainbowButton.com to allow data donation anonymously.

Don Casey thinks there is a market for an app to find physicians that accept blue button data.

Did you know that over 500,000 people have downloaded their BlueButton data from the VA and with adoption by United Health and Aetna the market in private health care markets puts BlueButton access at over 17M.

Q: Is EMR Adoption taking up more time for doctors. 

A:  Yes - Doctors often hate the technology. They don't hate what it is trying to achieve.

They want products that help their patients, fit their workflow and help them be more efficient.

West Wireless Health development preferences:

- Diagnostics

- Analysis

- Devices

Q: How do get doctors to the table to participate in the change process.

A: we need to align incentives. It is starting to happen. Switch from fee for service to pay for performance and no reimbursement for readmission within 30 days are having a radical impact.

Billions being invested in EMRs. Most are not developed for workflow improvement but for billing management. The transition from revenue cycle management to clinical outcomes will force a radical change.

1. What problem are you solving

2. Who will pay for the solution

3. Is there something unique about your offering

4. How will this lower the cost of health care

Who pays: 

18% of US Population managed by capitated health plans. (Kaiser, Geinsinger)

Large Self Insured: IBM, Exxon etc.

High Deductible Self-Directed Health Plans

We need to be more be more sophisticated in how you approach health care and mHealth:

- Clinical Applications

- Revenue and Workflow management

- Health Care industry (Pharma etc)

- Health and Wellness (Consumer wellness and prevention)

$1B of innovation money

Beacon Communities

$19B to be spent over next several years.

((tag: mhealth, mhealth summit, mobile))

Posted via email from ekivemark: pre-blogspot

#mhs11 super session - value proposition of mHealth

The initial drive will come from payers - the government, employers and insurers.

To really transform we need to engage consumers to manage their own vitality.

The move from fee for service to pay for quality. CMS ha changed hospital systems approach to quality due to payment reform.

A lot of development going in to home based monitoring. People recover better at home. Also least regulated.

Technical and regulatory obstacles:

- security because we need to share actionable information
- how to manage medical liability for large databases.

Mark Scrimshire
B: http://ekive.blogspot.com
....Sent from my iPhone

Posted via email from ekivemark: pre-blogspot

#MHS11 Mhealth Summit - the keynotes

This is a live blog post from the mHealth Summit. The summit is taking place from December 5-7th at the Gaylord National Convention Center, National Harbor, MD.

This is a live blog post, as such the notes are made in real time and posted with minimal editing. I am sharing these via Facebook, Twitter and my blog to help others get a snapshot of the activities at the conference. You can follow the tweet stream at #MHS11 or follow the mHealth Summit's twitter account @mhealthsummit.

Monday, December 5, 2011

9:45–10:15 AM — Opening Keynote

 

	Kathleen Sebelius Secretary U.S. Department of Health and Human Services
	Eric J. Topol, M.D. Vice Chairman West Wireless Health Institute

First the introductions:

Scott Campbell - Exec Director & CEO - Foundation for the National Institutes of Health kicks off the Summit.

Around 3,000 attendees in 2011 growing 25% from last year.

We need to learn from the mFinance community - they are further along in developing solutions than Health Care.

Rosemary Nelson - mHIMSS Taskforce Chair of HIMSS.  mHIMSS is the mobile offshoot of HIMSS.

Patricia Mecheal, Ph D. - Executive Director - mHealth Alliance -- focusing internationally on the poor, disadvantaged and vulnerable communities.

Robert Kaplan, Director - OBSSR - National Institutes of Health

Now on to the key notes….

Kathleen Sibelius - Secretary, US Dept of Health and Human Services (who has her talk on her iPad)

Almost every American has a cell phone and smartphones represent more than 50% of cell phones. The iTunes store alone has 12,000 apps related to health.

What is exciting is the rate of innovation in an area (Health Care) which has been traditionally sedentary.

When innovation is slow so is improvement.

Rapidly rising health care costs are imposing increasing burdens on families, employers and Government. 

We need information. Incomplete information about patients. Information Deficit is being addressed through the push for Health IT.

Office based doctors have grown in EMR use from 17% to 34% in less than two years. 

Mobile Health is the next logical extension. Cellphones are an incredible tool for engaging consumers in our own health.

iTriage and Pillbox gets a shout out as innovative solutions to help patients and providers.

What can the Administration do to promote innovation. The Government role is to provide research. Act as a catalyst.

Adoption of EMRs had not changed in many years to the Recovery Act set out to - set Standards for interoperable systems, Create Regional Extension Centers help small practices adopt, Health Information Exchanges to help interoperability. 

Recognized that it wasn't good enough to just dump paper in to electronic form. Meaningful Use emerged from this. We can now measure progress.

Government data was locked up and difficult to obtain. HealthData.gov was created to make the data accessible. 

Shining a spotlight on health problems. 1 in 5 students in college report some sexual assault during their college years. Why not use technology to protect themselves. Apps Against Abuse: Circle of 6 and onWatch were the winners.

TXT4Health from InfieldHealth also got a shout out.

Innovations are being per sued around Care Transitions to reduce hospital readmissions. 

Challenge 1: Support all innovations in Health Care - not just mhealth solutions.

Challenge 2: Help consumers understand that applications and data for consumers are safe and privacy is maintained.

We are heading for a future where we each take care of our health.

There are major opportunities to  export technology as developing countries grow.

Scott Ratzan, MD, MPA - VP - Global Health - Johnson & Johnson

TXT4BABY - 71% of people getting text messages are seeking advice from physicians.

TXT4BABY is expanding to Russia.

0.5M babies die in first year of life. We need to change that.

Only 10 years ago less then half the wor;d's population had ever made a phone call. Today over 5B people in a 7B world population now own a cellphone.

Eric Topol, MD - West Wireless Health - The Creative Destruction of Medicine 

@EricTopol

Kairos - The supreme - most opportune moment in history.

Digital World and the Medical Cocoon. They are starting to converge. 

 We are now talking about "Digitizing Man".

We have a new species - Homo Distractus

Joseph Schumpeter - Creative Destruction - now being applied to medicine. 

Johns Hopkins has announced it is closing it's medical library and going digital. This is the harbinger of change.

Eric gave a number of examples from FitBit 

AliveCor was demoed with the new Credit Card reader that can do ECG on your iPhone.

Skin Scan can snap a skin lesion and have it diagnosed remotely.

CellScope converts a cellphone to a microscope.

We are moving to a lab on a chip. 

EyeNetra.com for Refractive Assessment in eye tests. 

Sensimed - Triggerfish monitors eye pressure.

Qualcomm has announced 2net - a wireless health ecosystem

The Steve Jobs Autobiography looking at the future thought the biggest innovation of 21st century will be the intersection of medicine and technology.

We are entering the era of genomics sequencing. Eric demonstrated a handheld DNA Sequencer that could assess whether a patient would respond to Plavix.

The stethoscope is an icon of medicine. Why listen to a heart when you can see an ultrasound image using a portable scanner

There is now a technology to detect cracks in an artery. Using nano technology. Embedded nano sensors 

Eric has an ebook on "The Creative Destruction of Medicine"

((tag: mHealth, mHealth Summit, Mobile))

Posted via email from ekivemark: pre-blogspot

#MHS11 At the mHealth Summit at the National Harbor outside Washington DC

This week is the mHealth Summit which is being held at the Gaylord National Convention Center, National Harbor, MD. Around 3,000 people are expected to descend on National Harbor to attend the mHealth Summit. I am joining the throngs to catch up on the latest developments in mHealth

The pre-conference meetup last night brought together a sizable crowd. Many old faces and a lot of new people - all doing interesting things in the mHealth field.

I will be blogging from the conference and visiting the exhibition floor and reporting over the next couple of days.  Watch out for a stream of blog posts and tweets over the next few days.

((tag: mhealth, mhealth summit))

Posted via email from ekivemark: pre-blogspot