M2M Health Working Group

29th – 30th Sep 2014

TEC, DoT

0:00 Summary of Discussions Alok MITTAL

01:15 Conclusion

Agenda

Time

Speaker

Presentation

2

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

3

• 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)

4

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

5

• 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

6

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)

9

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

10

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.

12

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.

13

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.

Architecture 17

www.continuaalliance.org

TAN/PAN/LAN interface stack diagram 18

USB 2.0

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

20

• 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

24

• 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

25

• Agree on Adoption of Existing

Standards

• Identify the use-cases not covered

by ITU 810 and corresponding

standards

Thanks