1. Introduction to Medical Electronics
Day 5: Medical Data Storage
May 10, 2013 Charles J. Lord, PE President, Consultant, Trainer Blue Ridge Advanced Design and Automation

2. This Week’s Agenda
5/6 Medical Device Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

3. This Week’s Agenda
5/6 Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

4. To Recap
We have looked at the health ‘personal area network’ covered by ISO/IEEE 11073
Devices / Agents to collect data
Aggregates / Managers to gather the data from the devices for local management (self-care) or to send elsewhere
How to get the data elsewhere?

5. Medical and Health Data from point A to point B
The Challenge

6. Multiple record types and sources
Electronic Health Records
Personal Health Records
Pharmacy
Lab
Observations
Tests (non-lab, including exercise)
Imaging
Etc etc etc

7. Multiple communications channels
Internet
POTS
Cell
WAN
RF (back channel)
Paper (including scanning – tiff, pdf, fax)
And more….

8. Multiple regulatory bodies
HIPAA and other security concerns
21 CFR part 11 and other quality concerns
Personal privacy
Other government regulations
Industrial secrets (clinical trials)
Also includes standards for the comm channels

9. Who has solutions?
The players

10. Integrating the Healthcare Enterprise
Worldwide consortium of healthcare IT and data specialists (and industry) to develop standardization within care centers and between them
Primary contribution has been in frameworks and practices
Partnered with Continua Alliance

11. Health Level Seven International
International Group (55 countries)
Name is derived from the organization’s main focus – level seven of the ISO/OSI: Application
Thrust has been to move EHR (electronic health records) from the conglomerate of miscellaneous papers in a medical chart to a cohesive record set
Focus to be independent of nation, culture, or language (translatable to any language)

12. Health Level Seven International
Many HL7 standards now joint with ANSI and ISO
HL7 standards now released to the public free of charge, but joint standards are still for sale
Covers all types of record
XML structured records
Partnered with Continua Alliance

13. mHealth GSM (Groupe Speciale Mobile) Association
Cell-based health information applications
954 companies, carriers, associations (175 in US) participating
Many specialized (asthma, diabetes, etc)
Incorporated into the Continua Alliance

15. Glossary NHIN – National Health Information Network
NIST initiative
Now called HealthIT
HIE – Health Information Exchange
Project of the American Health Information Management Association (AHIMA)
CCD – Continuity of Care Document
Included in HL7
PCD-01 – Personal Care Device standard 1, Communication with a Device
iHE Standard

16. Why Continua
The alphabet soup of heath and medical record standards has become a Tower of Babel – a behemoth covered with people all speaking different languages
The Continua Alliance is working to bring the standards together to help make this work
Bottom line – what path to take from the PAN outward? Choose the best one – it is dependent on the recipient

17. Personal Repositories
Google Health – discontinued (no $$?)
Healthvault (Microsoft)
PatientsLikeMe
Onpatient
Many app-based, typically in the cloud

18. Links for more info http://www.continua.org

19. Links for more info http://www.ihe.net

20. References
Hu et al. Diet, lifestyle and the risk of type 2 Diabetes in women. NEJM 2001 Sep 13;345(11):790-7.
Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000; 343: 16–22
Cleland JF, Louis AA, Rigby AS, Janssens U, Balk AM. Noninvasive Home Telemonitoring for Patients With Heart Failure at High Risk of Recurrent Admission and Death: The Trans-European Network-Home-Care Management System (TEN-HMS) study. J Am Coll Cardiol. 2005;45(10): Lee R, Goldberg et al, 2003

21. References
[Potential cost reductions for the National Health Service through a telecardiology service dedicated to general practice physicians] Scalvini S, Zanelli E, Volterrani M, Castorina M, Giordano A, Glisenti F.; Ital Heart J Suppl Oct;2(10): (Italian).
[Therapy of chronic coronary artery disease: medical treatment vs. bypass surgery vs. coronary intervention].;Elsner D.;Internist (Berl) Dec;47(12):1251-4, Review (German)
Lord, C.J.; Colvin, D.P., "Falls In The Elderly: Detection And Assessment," Engineering in Medicine and Biology Society, Vol.13: 1991., Proceedings of the Annual International Conference of the IEEE , vol., no., pp.1938,1939, 31 Oct-3 Nov 1991

22. This Week’s Agenda
5/6 Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

23. Please stick around as I answer your questions!
Please give me a moment to scroll back through the chat window to find your questions
I will stay on chat as long as it takes to answer!
I am available to answer simple questions or to consult (or offer in-house training for your company)