Post on 02-Jul-2018
M2M Health Workgroup progress
• Regular Audio calls
• 4th Sep
• 21st Aug
• 6th Aug
• 22nd July
• 10th July
• 19th June
• 29th May
• 15th May
• 11th April (1st F2F Meeting)
• Govt & Standards Bodies
• ERNET, TEC, EU Standards, TSDSI
• Semiconductor/ Technology
• STMicroelectronics
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• Participation by Associations
• Continua India Working Group
Chairman
• AIMED (Association of Indian
Medical Device Industry)
• Participation by Medical Companies
• Apollo (Tele-Medicine)
• Medical Device Manufacturer
• HCL, WIPRO, Clarity Medical,
TrackMyBeat, Idiagnosis Philips,
Biosense, Accuster
• Service Providers
• HCL, Tech Mahindra, Huawei,
Ericsson, TCS, TrackMyBeat
Participating members
• TEC: Sushil Kumar, Parmatma Rai,
R K Tyagi
• Continua Health Alliance IWG:
Rajendra Gupta Chairmain
• STMicroelectronics: Alok Mittal
(Chairman, M2M_Health WG)
• TrackMyBeat: Ananda Sen Gupta
(Rapporteur, M2M_Health WG)
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Companies and Members in Alphabetical
order
• Accuster: Himanshu Saki
• Apollo Hospitals: Dr Ganapathy
• Biosense: Dr.Yogesh Patil, Dr.
Abhishek Sen
• Clarity Medical: Ashish Mishra
• Ericsson: Ms. Mini Vasudevan,
Surinder Kaushal
• ERNET: Dr. Neena Pahuja
• EU Standards: Dinesh Chand Sharma
Participating members
• HCL: Balamurugan R-ERS, Vishal,
Arvind Kumar Maurya
• Huawei: Sethumadhavan
Srinivasan
• Idiagnosis : T P Malik
• Philips: R, Mohan Kumar, Agrahari,
Shailesh, Karandikar, Amar, Marar,
Rajeev
• Robonik India: Subhash Punja
(AIMED)
• STMicroelectronics: Raunaque
Quaiser
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• TCS: Sriganesh Rao
• Tech Mahindra: Humairah Ishrath,
Ms. Richa Rai
• Trivitron: Professor Bhuvaneshwar,
G S K Velu (AIMED)
• TSDSI: Mr. Asok Chatterjee
• WIPRO: Anandaraj Thangappan,
Vijay kmar, Santhosh Madathil
Terms and AbbreviationsAbbreviations Meaning Abbreviations Meaning
BT Bluetooth Sub-Gig Sub Giga Hz Radio
Communication
BTLE Bluetooth Low Energy USB Universal Serial Bus
ECG ECG Electrocardiography WAN Wide Area Network
EHR Electronic Health Record PHI Protected Health
Information
ITU International
Telecommunications Union
TAN Touch Area Network
ISM Industrial, Scientific and
Medical Band of Spectrum
Like 2.4GHz, 865-868MHz
PAN Personal Area Network
LAN Local Area Network HRN Health Record Network
M2M Machine-to-Machine AHD Application Hosting
Device
NFC Near Field Communication
QoS Quality of Service
QOL Quality of Life
RMD Remote Monitoring Device
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Device Classifications 7
Country/ Market Risk / Example
US Market European Market Risk Level Example
Class I Class I Low Risk Non-Invasive Electrodes
Class II Class II-a and Class II-b Moderate low
and high risk
Electronic thermometers,
stethoscopes and
blood pressure monitors, ECG
Class III Class III High Risk Implantable defibrillator and
implantable
active device in general
Pandemic disease diagnosis
tool
Overview of Connected Health Device 8
Data capturing
Device
Data Interpretation,
Health Records
Services
User
Communication
Technologies
Use-cases of M2M-Health
Following use-cases contributed:
• Remote Patent Monitoring
• Smart Wearable Devices
• Elderly care/ assisted living
• Rural scenario
• Ambulance/Mobile care
• Video conferencing
• Asset Tracking and Device tracking
inside hospital
• Patient Identification (One Block
inside M2M-Health)
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Following Use-cases to be
contributed and debated
• Clinical monitoring
• Radiology data transfers
• Remote Drug Delivery
• Remote Robotic surgery
• Tele-call center
• LIS (Laboratory information System)
Items discussed per Use-case
S.No Items for each use-case Details/Comments
1 Description and Block-Diagram
2 Type of Device: Class 1/2/3 Classification w.r.t Low, Medium/High Risk
3 Communication channel used
4 Data bandwidth requirements Low/ Medium / High: Can change in future
5 Security requirements User Information shall be secure. The
communication shall be secure
6 Privacy User Information shall be protected
7 Compliance to standard: Name
8 Deviations: from standard For the purpose of contribution from the WG
9 Challenges
10 Criticality of QoS Quality of service criticality
11 Ownership of data Ownership with User/ Hospital/ Govt.
12 Patient Safety Requirements The Design should not cause reverse affects
on the user
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Top Level Summary of Use-case
requirements11
Usecase/
Requirements
Device
Type
Class I/
II/ III
Communication
Channel
Bandwidth Security Privacy Data
Owner
QoS
Personal health care
device
(Preventive)
II USB, BT, ZigBee,
NFC, Sub-Gig,
GPRS (2G/3G/4G),
WiFi
Low High High User High
Elderly care/
assisted living
II & III USB, BT, ZigBee,
NFC, Sub-Gig,
GPRS (2G/3G/4G),
WiFi
High High High User,
Care-
Giver,
Hospital
High
Remote Patent
Monitoring
(Continuous care)
II & III USB, BT, ZigBee,
NFC, Sub-Gig,
GPRS (2G/3G/4G),
WiFi
High High High User,
Hospital
High
Rural scenario
(Shared Resources)
II USB, BT, ZigBee,
NFC, Sub-Gig,
GPRS (2G/3G/4G),
WiFi
Low High High User,
Hospital
High
Ambulance/
Mobile care
II & III USB, BT, ZigBee,
NFC, Sub-Gig,
GPRS (2G/3G/4G),
WiFi
High High High User,
Hospital
High
Kindly Refer to complete table in the Working Document
Continua Design Guidelines adopted for e-
health interoperability by ITU• Geneva, 19 December 2013 – An important milestone for global e-health
standardization has been achieved with final approval of a new standard that
will better enable interoperability between e-health devices. The standard -
Recommendation ITU-T H.810 - contains Continua Health Alliance’s Design
Guidelines providing “Interoperability design guidelines for personal health
systems”. The Continua Design Guidelines provide for end-to-end, plug-and-
play connectivity in personal connected health devices, which are based on
global industry standards for interoperability.
• Devices such as wireless blood pressure cuffs, weight scales and a wide
range of activity trackers can play a critical role in the prevention and
improved management of chronic conditions such as diabetes, hypertension
and heart disease. Establishing global interoperability standards will stimulate
innovation and nourish the personal connected health ecosystem. For
manufacturers, standards will decrease time-to-market, reduce development
costs and increase efficiencies. In particular they will enable quicker, less
expensive integration to electronic medical records (EMR) or health
information exchange (HIE) platforms.
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Continua compatibility with OneM2M
• Mr. Dinesh July’2014:
• OneM2M => Continua is a Partner Type 2 in the oneM2M Partnership Project. Mr.
Michael Kirwan (Editor of the document - ITU-T H.810 Continua Design Guidelines)
is regularly participating in the technical work of oneM2M. Currently Continua is
evaluating in their TWG (Technical Working Group) to better understand the
differences (specifically, what does Continua need to change and what’s going
across the wire). The target is that Continua will reference oneM2M Specifications
in their Guidelines. Continua currently also evaluate, how they can offer a demo of
oneM2M architecture in the oneM2M Showcase on 9th December in Sophia
Antipolis.
• ETSI’s eHEALTH is very well aware and cooperates with Continua & vice versa.
• Comments from Michael J. Kirwan | Technical Operations Director to Sh. Rajendra
Gupta (Continua IWG)
Yes, our Endorphin (CDG 2014) was contributed to oneM2M where Continua is
a Partner Type II organization. We have also contributed use-cases and requirements
sufficient for oneM2M's first release and have been involved with ensuring Continua's
future planned used-cases and requirements.
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Device Classes Segmentation 14
TAN: Touch Area
Network
PAN: Personal Area
Network
LAN: Local Area
Network
WAN: Wide Area
Network
BAN: Body Area
Network
Segment wise Communication 15
Segment Range Suitable For Recommended Technology
TAN: Touch
Area
Network ~10 CMImmediate user
proximityNFC, USB, BTLE
PAN: Personal
Area
Network
BAN: Body
Area Network
~ 10 meters
Inter-Device
Communication,
Communication
with Gateway/
Aggregator
USB, BT, ZigBee
LAN: Local
Area
Network
< 20 meters
Communication
with Gateway/
Aggregator
USB, BT, ZigBee, WiFi
WAN: Wide
Area
Network
>1 KmData upload via
Gateway
Cellular (GPRS, 3G), LTE, Wireline,
Wi-Fi, Fiber Optics
Technology Adopted Profiles 16
Technology Adopted Profiles References
Communication
USB
Universal Serial Bus Device
Class Definition for Personal
Healthcare Devices
<http://www.usb.org/deve
lopers/devclass_docs/>
Bluetooth
Bluetooth Low Energy
Bluetooth SIG, Health
Device Profile, version 1.1.
https://www.bluetooth.org
/Technical/Specifications/
adopted.htm
NFC
(ISO14443/ISO15693)
NFC Forum (2013),
Personal Health Device
Communication 1.0.
http://www.nfc-
forum.org/specs/spec_lic
ense
ZigBee
ZigBee Alliance, Health
Care Profile Specification,
version 1.0,revision 15.
WAN Scope 19
EMR: Electronic medical record
EHR: Electronic Health Record
PHR: Personal Health Record
Privacy & Security (HIPAA)
• Privacy Rule
• Disclosures of PHI (Protected
Health Information) require the
covered entity to obtain written
authorization from the individual for
the disclosure
• Covered entities may disclose
protected health information to law
enforcement officials
• A covered entity may disclose PHI
(Protected Health Information) to
facilitate treatment, payment, or
health care operations without a
patient's express written
authorization
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• Security Rule
• The Security Rule complements the
Privacy Rule
• Security Rule deals specifically with
Electronic Protected Health
Information (EPHI)
• It lays out three types of security
safeguards required for compliance:
administrative, physical, and
technical
HIPAA Standards: Health Insurance Portability and Accountability Act
http://en.wikipedia.org/wiki/HIPAA
Security technologies for
Communication & Storage21
Reference: ITU-T H.810 Interoperability design guidelines for personal health systems
Test Requirements (1/2)Spec Description H.810 Series Version
Conformance testing: Health record network (HRN) interface H.EH-HRN-01-TD-WP2-0203r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 1: Optimized Exchange Protocol (IEEE Std 11073-20601a-2010): Agent H.EH-PAN-01-TD-WP2-0205r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 2: Optimized exchange protocol (IEEE 11073-20601a-2010): Manager H.EH-PAN-02-TD-WP2-0206r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 3: Continua Design Guidelines: Agent H.EH-PAN-03-TD-WP2-0207r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 4: Continua Design Guidelines: Manager H.EH-PAN-04-TD-WP2-0208r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5A: Weighing scale H.EH-PAN-05.01-TD-WP2-0209r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5B: Glucose meter H.EH-PAN-05.02-TD-WP2-0210r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5C: Pulse oximeter" H.EH-PAN-05.03-TD-WP2-0211r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5D: Blood Pressure Monitor H.EH-PAN-05.04-TD-WP2-0212r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5E: Thermometer H.EH-PAN-05.05-TD-WP2-0213r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5F: Cardiovascular fitness and activity monitor H.EH-PAN-05.06-TD-WP2-0214r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5G: Strength fitness equipment H.EH-PAN-05.07-TD-WP2-0215r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5H: Independent living activity hub H.EH-PAN-05.08-TD-WP2-0216r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5I: Adherence monitor H.EH-PAN-05.09-TD-WP2-0217r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5K: Peak expiratory flow monitor H.EH-PAN-05.11-TD-WP2-0218r1b-MA2.doc
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Test Requirements (1/2)Spec Description H.810 Series Version
Conformance testing: PAN/LAN/TAN Interface Part 5L: Body composition analyser H.EH-PAN-05.12-TD-WP2-0219r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5M: Basic electrocardiograph H.EH-PAN-05.13-TD-WP2-0220r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 5N: International normalized ratio H.EH-PAN-05.14-TD-WP2-0221r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 6: Device specializations: Manager H.EH-PAN-06-TD-WP2-0222r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 7: Continua Design Guidelines: Agent for Bluetooth Low Energy (BLE) H.EH-PAN-07-TD-WP2-0223r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 8: Continua Design Guidelines: Manager for Bluetooth Low Energy (BLE) H.EH-PAN-08-TD-WP2-0224r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 9: Personal Health Devices Transcoding: Agent for Bluetooth Low Energy (BLE) H.EH-PAN-09-TD-WP2-0225r1b-MA2.doc
Conformance testing: PAN/LAN/TAN Interface Part 10: Personal Health Devices Transcoding: Manager H.EH-PAN-10-TD-WP2-0226r1b-MA2.doc
Conformance testing: PAN/LAN/TAN: USB host H.EH-PAN-USB-TD-WP2-0204r1b-MA2.doc
Conformance testing: WAN Interface Part 1: Web services interoperability: Sender H.EH-WAN-01-TD-WP2-0227r1b-MA2.doc
Conformance testing: WAN Interface Part 2: Web services interoperability: Receiver H.EH-WAN-02-TD-WP2-0228r1b-MA2.doc
Conformance testing: WAN Interface Part 3: SOAP/ATNA: Sender H.EH-WAN-03-TD-WP2-0229r1b-MA2.doc
Conformance testing: WAN Interface Part 4: SOAP/ATNA: Receiver H.EH-WAN-04-TD-WP2-0230r1b-MA2.doc
Conformance testing: WAN Interface Part 5: PCD-01 HL7 Messages: Sender H.EH-WAN-05-TD-WP2-0231r1b-MA2.doc
Conformance testing: WAN Interface Part 6: PCD-01 HL7 Messages: Receiver H.EH-WAN-06-TD-WP2-0232r1b-MA2.doc
Conformance testing: WAN Interface Part 7: Consent Management: Sender H.EH-WAN-07-TD-WP2-0233r1b-MA2.doc
Conformance testing: WAN Interface Part 8: Consent Management: Receiver H.EH-WAN-08-TD-WP2-0234r1b-MA2.doc
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Recommendations for M2M_Health
• Need of Certification Labs
• Communication Technology profile
• Medical Device Certification (Ref.
FDA equivalent)
• User Identification
• Aadhar (UID) Number and database
can be used
• Biometric
• Smart-card
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• Standard’s Availability
• Shall be easily available for Indian
companies (~BIS Standards)
• BIS Standards already available
covering some Healthcare designs
• Continua guidelines seems most
compatible for India’s needs
• Technology Certified devices
adoption
• Devices certified by BT,USB,ZigBee
forums shall be adopted
Plans for Next 3 months
• Collect and Close the Open use-
cases
• Continue the Monthly Audio
conferences
• Identify the use-case
implementation for India context
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• Agree on Adoption of Existing
Standards
• Identify the use-cases not covered
by ITU 810 and corresponding
standards