Can anyone do this assignment by paying much attention to the details and by reading the instructions carefully? Has to be done in own words from scratch.

MDTmag.com12 / November/December 2016

Emphasis On IoT

Design Considerations for a Future of Connected Care By Phani Bidarahalli, General Manager and Global Practice Head, Healthcare & Life sciences Engineering, Wipro Ltd.

A s current trends in technology and healthcare accelerate the move towards a connected healthcare

enterprise, data is quickly becoming the new currency in the healthcare econo- my. By fostering big data trends such as volume, velocity, veracity and variations, medical devices are growing sources of big data. As the reliance on healthcare data continues to grow, the inter-con- nectivity and regulatory governance of these devices plays a vital role in patient monitoring, clinical decision support and care delivery in healthcare systems.

With the growing value of data in mind, it’s concerning that the interop- erability of medical devices has been a long-standing issue in the healthcare industry, and caretakers are taking notice. According to the Gary and Mary West Health Institute1, 60 percent of nurses believe preventable errors can be reduced through greater device and system con- nectivity. Devices such as infusion pumps, ventilators, blood pressure monitors and other vital sign monitors are critical for delivering quality care. Connectivity of these devices can assist in reducing reporting and communication errors, en- abling physicians to provide better care.

Regulatory moves towards value-based care and meaningful use, where payments are linked to healthcare outcomes, is further accelerating the move towards a connected healthcare enterprise and helping to shape interoperability stan- dards. For example, Stage 2 Meaningful Compliance mandates recording of blood pressure, lab tests, vital signs, weight and height in the electronic health record

(EHR) for 80 percent of the patient population in the system, according to HealthIT.gov2.

The New Era of Connectivity Devices and Standards Interoperability is still a major challenge in the medical device industry and there are many bodies working towards achiev- ing the interoperability goals for medical devices. Organizations such as Integrated Healthcare Enterprise (IHE)3, Continua Personal Connected Health Alliance, Health Level Seven International4 and the IEEE Standards Association5 are working collaboratively to defi ne standards for medical device connectivity. There is an existing standard under IEEE 110736 for information model, device communication and transport level profi les for medical de- vices in various settings. These standards defi ne the data organization, communica- tion protocol and service model.

Parallel to IEEE 11073, we also see the “Patient-Centric Integrated Clinical Environ- ment” (ICE) based on the ASTM F2761- 20097 standard. ICE is supported by an open source development tool called OpenICE8. It provides a scalable, connectivity-enabled plug-and-play platform for many types of devices used in patient monitoring.

We are also witnessing a move towards a platform-based approach (middleware) to device connectivity away from a point-to-point approach. Data

from the devices fl ows to these platforms, enabling central monitoring, analytics and custom workfl ows within hospitals and provides clinical decision support.

Four Keys to Safe & Secure Connected Device Design With the value, demand and volume of healthcare data rising exponentially, there are plenty of factors for connected equip- ment designers to consider. Below are solutions to four challenges all medical device original equipment manufacturers (OEMs) will face as they prepare for the future of connected care:

1. Ensuring Timestamp Accuracy As primitive at it may seem, the

biggest debate today in the medical world is, “What is the correct time?” Is it the time on the wall clock? The time on the device? Or the time on the doctor’s watch? Timestamping of measured data is a crucial aspect of collecting data, as caregivers working across devices need to know not only what type of care was given to a patient, but exactly when. To meet that need, caregivers cannot simply go by a nurse’s recording of time from a wall clock. Devices must recognize the Network Time Protocol (NTP)9 of out- side devices and support time synchroni- zation functionality to synchronize device time to server time. Designers should never assume the internal clock on their device will be the only source of time.

2. Eliminating User Actions The less time a caregiver spends man-

ually using or entering data into a device the better, but some workfl ows simply require user action on the device. The re- quirement of proprietary workfl ow issues should be avoided at all costs to eliminate the probability of human error. Devices instead should be designed to perform

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data exchanges as independently as possi- ble without the need for user intervention. Designers also need to recognize and un- derstand the broader setting a device will be used in. For example, the requirements of a device in a cardiac care center can vary differently from the requirements of the same device in an orthopedic setting. Building research and development teams that connect medical device OEMs with usability experts and clinicians will help streamline workfl ow improvements.

3. Securely Pairing Technologies Adoption of technology like Bluetooth

can present some specifi c challenges regarding the pairing and un-pairing of devices and may lead to data loss and un- secure communication. It is important for designers to understand the exact pairing needs of individual devices. Users cannot arbitrarily pair devices because they could potentially expose patients to information that is not standardized. If a nurse wants to send a prescription to a specifi c infusion devices, the infusion device and the device sending the prescription need to have a perfect handshake so the source can be authenticated. This could prevent a nurse from accidentally delivering a prescrip- tion to the wrong device. Medical device OEMs need to adopt secure public and private key encryption mechanisms and institute a design and audit process that frequently monitors any potential data loss. 4. Managing Compliance

Health Insurance Portability and Ac- countability Act (HIPPA) compliance is a key area of concern for device manufac- turers. With more and more technology manufacturers embracing open source technologies and commercial libraries available for SSL/TLS and data encryp- tion, it is important to understand how the use of those technologies will impact HIPPA compliance. Device designers must understand the trail of data that could potentially be left on another device and should conduct accessibility testing of open source packages to insure they are securing patient records and data in a way that meets HIPPA requirements.

Future technology trends will drive the need to integrate end-point patient interac-

Innovative solutions for medical devices from concept to series production

Micro Systems Technologies – engineering for life

Micro Systems Technologies

Neuhofstrasse 4, CH-6340 Baar, Switzerland Phone + 41 (44) 804 63 00, Fax + 41 (44) 804 63 01, [email protected]

MST Group. Active around the globe, the Micro Systems Technologies (MST) Group consists of four technology companies with more than 1000 employees in three countries: > DYCONEX AG (CH) > LITRONIK Batterietechnologie GmbH (DE) > Micro Systems Engineering GmbH (DE) > Micro Systems Engineering, Inc. (USA)

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tion and delivery devices as part of clinical decision support systems and participate in clinical decision support when all data is not present in the same device.

References 1 – http://www.multivu.com/players/En-

glish/7469651-west-health-survey/ 2 – https://www.healthit.gov/providers-profession-

als/achieve-meaningful-use/core-measures-2/ record-vital-signs

3 – https://www.ihe.net/ 4 – http://www.hl7.org/ 5 – https://standards.ieee.org/develop/intl/iso.html 6 – http://www.11073.org/ 7 – http://www.mdpnp.org/mdice.html 8 – https://www.openice.info/ 9 – http://www.ntp.org/ntpfaq/NTP-s-def.htm MDT

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