ehealth - medical systems interoperability & mobile health

UL and the UL logo are trademarks of UL LLC © 2013

eHealth – Medical Systems

Interoperability & Mobile Health

October 30, 2013

Presenters:

Anura Fernando - Principal Engineer, Medical Software & Systems Interoperability

Mark Leimbeck – Program Manager, Quality and Training

Moderated by:

Laura Elan – Program Manager, Global Service Lead - eHealth

Copyright © 2013 UL LLC

AGENDA

Why Are We Here?

New Devices and the Need for Safe Interoperability

Using Standards to Support Regulations

Conclusion

2

Copyright © 2013 UL LLC

Why Are We Here?

RISK!

More specifically, from IEC 60601-1, Clause 16.1

.…The MANUFACTURER of an ME SYSTEM that is (re)configurable

by the RESPONSIBLE ORGANIZATION or OPERATOR may use

RISK MANAGEMENT methods to determine which configurations

constitute the highest RISKS and which measures are needed to

ensure that the ME SYSTEM in any possible configuration does not

present an unacceptable RISK….

3

Copyright © 2013 UL LLC

Examples

ABSENCE OF INTEROPERABILITY

PATIENT CONTROLLED ANALGESIA PUMPS1 - VA representatives

recently stated that PCA pumps with an integrated CO2 monitor

could have prevented 60% of adverse events in 69 root cause

analyses related to PCA pumps.15

Copyright © 2013 UL LLC

4

Examples

INTEROPERABILITY “INDUCED” ERRORS

EHR prompt nearly kills prison inmate2

“An inmate at a California correctional facility nearly received a lethal

dose of heart medication last week at the prompting of a newly

implemented electronic health record system.”

Copyright © 2013 UL LLC

5

Regulatory Response

It Has Come to Our Attention Letter†

“It has come to our attention that you are currently marketing the XXXX

analyzer …

… Since your app allows a mobile phone to analyze the dipsticks,

the phone and device as a whole functions as an automated strip

reader. When these dipsticks are read by an automated strip reader,

the dipsticks require new clearance as part of the test system.

Therefore, any company intending to promote their device for

use in analyzing, reading, and/or interpreting these dipsticks

need to obtain clearance for the entire urinalysis test system…”

Copyright © 2013 UL LLC

6 † FDA Website 5/21/2013

Who is Responsible?

Manufacturer of any product which is1

“an instrument, apparatus, implement, machine, contrivance, implant,

in vitro reagent, or other similar or related article…

• intended for use in the diagnosis of disease or other conditions, or in

the cure, mitigation, treatment, or prevention of disease… or

• intended to affect the structure or any function of the body of man or

other animals…”

1. section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration

(FDA)

Copyright © 2013 UL LLC

7

And What is the Manufacturer

Responsible For?

Preamble5 Comment #4

“…In fact the new regulation is less prescriptive and gives the

manufacturer the flexibility to determine the controls that are

necessary commensurate with risk.

The burden is on the manufacturer, however, to describe the types

and degree of controls and how those controls were decided

upon…”

Copyright © 2013 UL LLC

8

What Decisions are Being Made?

21 CFR 820.302 Design controls. Each manufacturer shall:

• establish and maintain procedures to control the design

• ensure that the design requirements address the:

• intended use of the device,

• needs of the user and patient

• include software validation and risk analysis, where appropriate…

9

Copyright © 2013 UL LLC

Who is Responsible?

Management is ultimately responsible for determining and

implementing risk based decisions to ensure the safety and

effectiveness of the device

10

Copyright © 2013 UL LLC

The World Today – New Devices and the

Need For Safe Interoperability

Copyright © 2013 UL LLC

12

Smart Grid – Even More Heterogeneity

Slide 13 http://energyinformative.org/wp-content/uploads/2012/01/smart-grid.jpg

Key Common Challenges for Systems Integrators

Understanding What Can Go Wrong

Lack of Clarity on Design Requirements and Needs

Inadequate Risk Controls

Time and Cost

Responsibility / Accountability (Who Owns the System?)

Slide 14

…can result in…

Slide 15

- Improper V&V – no pre-release

integration testing http://50quidsoundboy.net/wp-content/uploads/2011/05/thumb-21367-radiation_therapy.jpg

- Integrated re-used sw into

incompatible hardware (no interlocks)

- “unlikely” sequence of keystrokes

Ariane 5

Floating point value too large to be

represented by signed integer

Therac - 25

Mars Climate Orbiter

- Mismatched units

So, Are There Medical Device and HIT Risks?

Slide 16

http

://henic

an.c

om

/2011

http://www.telemedicineinsider.com/

Acute Care

Telemedicine

A Growing “Ecosystem” of Healthcare Systems

Slide 17 http://www.cs.purdue.edu/homes/bertino/IIS-eHealth/images/ehealth_full.jpg

…connected via communications technology

creates the world of eHealth and mHealth

18

http://intpmcomms.com/wp-content/uploads/2010/08/iStock_000011296304XSmall1.jpg

“The Future” is Here

Slide 19

http

://ww

w.th

em

ary

sue.c

om

/wp

-conte

nt/u

plo

ads/2

012/0

1/tric

ord

er-s

pock.jp

g

Addressing Safety and Security

Slide 20

http://scholar.lib.vt.edu/ejournals/JOTS/v32/v32n1/images/mcquade1.jpg

Safety and Security Defined and Evolving

SAFETY: freedom from unacceptable risk [ISO 14971:

2007]

SAFETY: freedom from unacceptable RISK of physical

injury or damage to the health of people or damage to

property or the environment

[SOURCE: IEC 80001-1:2010, definition 2.30]

DATA AND SYSTEM SECURITY: an operational state of a

medical IT network in which information assets (data and

systems) are reasonably protected from degradation of

confidentiality, integrity, and availability. [IEC 80001-1:

2010] Slide 21

FDA “Accessory Rule” – Avoiding Weak Links

From FDA Mobile Medical Application Draft Guidance:

“Accessories to classified devices take on the same classification as

the "parent" device. An accessory such as software that accepts

input from multiple devices usually takes on the classification of the

"parent" device with the highest risk, i.e., class.”; Final Rule, Medical

Devices, Medical Device Data Systems, 76 Fed. Reg. 8637, 8643-

8644 (Feb. 15, 2011).

The Medical Device Data Systems (MDDS) Final Rule changes

this and allows for ease of innovation

Slide 22

Regulations Begin Considering the Risks

FDA Final Rule: MDDS – 15 Feb 2011

FCC Requirements for MBAN and FDA MOU – 24 May 2012

Draft Guidance for Home Use Devices – 12 Dec 2012

FDA Draft Guidance: Management of Cybersecurity – 14 June 2013

FDA Guidance: RF Wireless Technology…– 13 Aug 2013

FDA Final Rule: Unique Device Identification Final Rule – 24 Sept 2013

FDA Draft Guidance: Global UDI Database – 24 Sept 2013

FDA Guidance: Mobile Medical Applications – 25 Sept 2013

23

Are You an “App” Developer?

Low Risk – Unregulated?

Higher Risk – Regulated?

Have you considered the uses?

VS.

Have you considered the users?

VS.

Have you considered the environment?

WWW

Acme Insurance

What are the risks with safety-related data?

1001010010100101101010

Incorrect Information Exchange

31

1001010010100101101010 X

Single Event Upset or Data Corruption

EXAMPLE:

Information Not Provided

32

No Data

EXAMPLE:

Incorrect Timing of Information

33

1001010010100101101010

Information provided when app is inactive

EXAMPLE:

Premature Termination

34

EXAMPLE:

Dropped Signal

Have you considered systems safety and security?

WWW

Acme Insurance

What could go wrong?

36

WWW

Acme

Insurance

Do you test to support your safety claims?

Modified from: http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm260345.jpg

Do you test to support your security claims?

38

)))))))

Cryptographic Verification

http://img.mit.edu/newsoffice/images/article_images/20110214123646-1.jpg

Using Standards to Support Regulations

Copyright © 2013 UL LLC

Assurance Cases Can Help Support Claims

Slide 40

https://buildsecurityin.us-cert.gov/bsi/1051-BSI/version/default/part/ImageData/data/Assurance_Cases_and_LifeCycle_Processes.png

Standards Can Help Guide Assurance Cases

Slide 41

https://buildsecurityin.us-cert.gov/bsi/1051-BSI/version/default/part/ImageData/data/Assurance_Cases_and_LifeCycle_Processes.png

Safety Standards

Standards for eHealth and mHealth Interoperability

Aug 6, 2013 FDA Recognized Consensus Standards Support Interoperability:

There are 25 new standards for interoperability grouped mainly into three categories:

1. Managing risk in a connected and networked environment;

2. Nomenclature, frameworks and medical device specific communications,

including system and software lifecycle process;

3. Cybersecurity standards from the industrial control systems arena that are

relevant to medical devices.

Coming soon:

AAMI / UL 2800 – interoperable medical device interface safety

…and many more are here and coming…

Slide 42

UL Works Directly with Government Agencies

To Help Inform Health IT Policy

43

FDA Safety and Innovation Act (FDASIA WG)

http://www2.idexpertscorp.com/images/uploads/ehr.jpg http://static.ddmcdn.com/gif/wireless-network-1a.jpg http://www.commercialintegrator.com/images/

We Have The Technology…We Can Build It… Standards

and Regulations are Emerging…

Are You Prepared ???

44

IDEA PRODUCT

&

SYSTEM

Managing innovation and regulatory change

Mobile Medical Applications

Wireless Medical Devices

Hospital IT Equipment Providers

http://www.securedgenetworks.com

Managing innovation during regulatory change

IDEA PRODUCT

In the Development Cycle or Already in the Field

Technological

framework

Safety

Framework

Safety

Framework

Regulatory

Framework

UL can be

your

partner

Comprehensive

Suite of Services

Mobile Medical Apps

Advisory services for medical device classification, training navigation of regulations and submission support,

Quality Management System registration

Assessment to interoperability standards

Usability advisory services, testing, and certification

FDA Submission support including pre-audit services

EMC and wireless co-existence testing

Clinical & pre-clinical testing and test planning

Wireless Medical Devices

• Advisory services for satisfying regulatory guidance

• Testing services using international consensus standards to support regulatory compliance claims:

• Coexistence

• Performance

• Security

• Data integrity

• Quality of service (QoS)

• Continua Alliance Testing

• Safety / EMC

46

Thank You For Your Interest

How can UL help you? More information – www.ul.com/eHealth

Email: Medical.Inquiry@ul.com

Hospital IT Infrastructure

• Advisory services for Medical Device Data Systems (MDDS) classification and regulatory strategy

• Testing / conformance to global standards (including recent FDA recognized consensus standards for interoperability)

• Advisory services for medical device classification, training, and regulatory submission support for system integrators

Contact UL

Email: Medical.Inquiry@ul.com

Web: www.ul.com/Medical

47