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Emerging Technology in Healthcare and Conducting an ERM Risk Assessment Mike Midgley RN, JD, MPH, CPHRM, FASHRM Vice President, Healthcare Risk Engineering Swiss Re Corporate Solutions

Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

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Page 1: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Emerging Technology in Healthcare and Conducting an ERM Risk Assessment

Mike Midgley RN, JD, MPH, CPHRM, FASHRM Vice President, Healthcare Risk Engineering

Swiss Re Corporate Solutions

Page 2: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

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Learning Objectives

• Summarize benefits & liability exposure associated with 3D printing, robotics and drones in healthcare.

• Describe how to conduct a comprehensive review of risk issues with emerging technology using domains and a risk list.

• Identify the steps to conduct an ERM risk assessment.

Page 3: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

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3D Printed Medical Devices & Equipment

Page 4: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Automated method of manufacturing 3-dimensional items in which 2D layers are printed successively, one on top of the other aka “Additive Manufacturing”

As opposed to ” Subtractive Manufacturing” such as carving, sculpting, and milling

4

3D Printed Medical Devices & Equipment

Page 5: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• Medical 3D printing began in the early 2000s - custom dental implants

• Today 3D printers - hearing aids, contact lenses, implants, and prosthetics made to a pt’s exact body shape/contour (fraction of cost)

• MI hospital implanted a 3D printed device into a 3 mo old boy with bronchial condition and saved his life

• Man who had 75% of his skull replaced with a 3D printed implant

• Researchers fabricate human tissue with 3D printers and a pt’s own DNA

• Biodegradable scaffolds allow for printing an organ’s framework, inject with pt’s living cells in exact locations where they are likely to grow naturally -pt’s own cells are injected into bio printing material – lower risk of rejection

• Future = print a customized liver, kidney, pancreas, or heart using bio-ink – a blend of living cells that a printer will assemble into living tissue layer by layer (decrease mortality rate from chronic disease & render pt waiting lists a thing of the past)

3D Printed Medical Devices & Equipment

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Page 6: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

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According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31%

per year between 2014 – 2020.

3D Printing = $14 Billion in Revenue

Medical Applications market expected to reach $965.5 million globally in 2019 (Transparency Market Research)

Page 7: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• FDA has cleared 85 applications for 3D printed devices -none for high-risk devices requiring pre-market approval

• May 2016 FDA issues “Technical Considerations for Additive Manufacturing” draft guidance for design & manufacturing, & device testing, which includes characterization, validation & verification -not intended to address 3D printed products containing biologics, cells or human tissues

• Manufacturer obligation to register with FDA

List their devices

Comply with General Controls

Meet Quality System requirements (including design controls and supplier controls)

Device testing considerations

7

3D Printed Medical Devices & Equipment FDA Considerations

Page 8: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• Bioprinting is one of the fastest-growing areas of 3D printing (inkjet-style printers to make living tissue)

• Organovo plans to commercialize 3D-printed liver tissue. Partnership with the National Eye Institute & the National Center for Advancing Translational Sciences to print eye tissue

• Mount Sinai hospital (Toronto) developed technique for recreating replacement joints using a pt’s own tissues. 3D printer makes a bone replacement using a calcium phosphate compound - has many of same properties as human skeleton

8

3D Printed Medical Devices & Equipment Changing Medicine

Page 9: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• The “Open Hand Project” - volunteers produce 3D printed prosthetic hands. The prosthetics are free (if people can afford to pay, avg. $80 – $150)

• “Iron Man” prosthetic forearm and hand developed by “Limbitless Solutions” $300

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3D Printed Medical Devices & Equipment - Prosthetics

• The group “Field Ready” 3D print umbilical cord clamps for local hospitals in Haiti, helped the earthquake victims in Nepal, and is training RedCross rescue teams to use 3D printing technology

Page 10: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• University of Kansas Hospital –MDs study & practice on exact replicas of pts’ organs before surgery (shorter surgeries, reduced anesthesia exposure & fewer complication) – in-house 3D printer at hospital

• Phoenix Children’s Hospital/Children’s National Medical Center in Washington, D.C.,/Children’s Hospital of Philadelphia — randomized, single-blinded clinical trial to demonstrate the quantitative impact of 3D printing in healthcare - enroll 400 pts at 14 sites, split into two cohorts — traditional surgical planning v 3D printed implants prep

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3D Printed Medical Devices & Equipment Teaching and Prepping for Procedures

Page 11: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• Coverage

Criteria under which a product or service will be insured for payment

• Coding

Identification system to describe product,service, procedure (HCPCS, CPT, ICD codes)

• Payment

Amount paid for a product, service, or procedure

Inpt. v Outpt.

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3D Printed Medical Devices & Equipment Reimbursement Considerations

Page 12: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• FDA clearance does not guarantee Medicare COVERAGE

• Different standards

FDA – “Safe & Effective”

CMS – “Reasonable & Necessary”

• IF 3D printed implants are “safe & effective,” WILL payers determine they are “reasonable & necessary?”

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3D Printed Medical Devices & Equipment Reimbursement Considerations

• Will new 3D printed implant procedure codes & reimbursement reflect added MD prep/planning?

• Or is procedure time shorter b/c implant is custom fit & requires less surgical work?

Page 13: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• Will 3D printed devices be more economical w/ fewer complications, better outcomes?

• Case Example:

Simpler, personalized 3D treatments (custom wearable braces) for spine scoliosis may one day replace complex device implant surgery

Shift in treatment would result in lower payment to surgeons/ physicians

Will there be a disincentive to offer these 3D personalized solutions to patients?

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3D Printed Medical Devices & Equipment Reimbursement Considerations

Page 14: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

3D Printing ERM Risk List

Operational Multi-step process; breakdowns in any step impacts whole process;

calibration/maintenance

Clinical /Pt Safety Customized product; ability to see and “practice” complex procedures; durability,

sterility of devices not fully known; uniformity; infection; allergic response, EBM

Strategic Organization can be seen as cutting edge, improved reputation

Financial Set up costs may be high; but can deliver lower-cost products in time; med mal

insurance costs

Human Capital

Increased investment in highly trained individuals; attractive environment for

cutting-edge researchers; some worker exposure to particulate matter (risks not

fully understood); T&E

Legal / Regulatory

FDA clearance for individual devices; potential OSHA exposure from particulate

matter and high-temperatures required to print devices; Who “owns” device or

process?; intellectual property/patent issues; SOC issues; product liability; risk

transfer between hospitals and manufacturers

Technology Highly sophisticated equipment; compatibility of all components (i.e., imaging,

materials and printers); Software/hardware, malware/viruses possible

Hazard

Durability of materials; do devices function as intended?; need for back-up

systems in event of electrical outages, computer crash; emergency management

plans

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Page 15: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Resources for 3D Printing in Healthcare Medical Articles

Cornwall, J, “The Ethics of 3D Printing Copies of Bodies Donated for Medical Education and Research:

What is There to Worry About?”, AMJ 2016; 9(1): 8-11.

Lee, N, “The Lancet Technology: 3D Printing for Instruments, Models, and Organs?”, The Lancet 2016;

Vol 388: 1368.

Neely, EL., “The Risks of Revolution: Ethical Dilemmas in 3D Printing from a US Perspective”,Sci Eng

Ethics 2016; 22:1285-1297.

O’Neill, B et al., “Transcatheter Caval Valve Implantation Using Multimodality Imaging”,JACC:

Cardiovascular Imaging 2015, Vol. 8, No.2: 221-225 (Letter and Reply, JACC:Cardiovascular Imaging,

Vol. 8, No. 8: 987-989).

3D Printing In Medical Applications Market Is Expected To Reach USD 965.5 Million Globally In 2019 http://www.meddeviceonline.scom/doc/printing-medical-applications-transparency-market-research-0001 (accessed 2/16/17)

Regulatory Materials

U.S. Food & Drug Administration, 3D Printing of Medical Devices, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm (accessed 2/16/17)

FDA DRAFT Guidance, “Technical Considerations for Additive Manufactured Devices,” May 10, 2016 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf (accessed 2/16/17)

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Page 16: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• Two major categories –

– Direct Patient Care Robots – surgical robots, exoskeletons for walking, interactive/assistive (AI companionship)

– Indirect Patient Care Robots – pharmacy, delivery, disinfection robots

• Research on novel uses of robots –

– New uses for assisted surgery/procedures

– Nano-bots

Robotics

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Page 17: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• MIT (July 2016) - developed an altered robot with AI providing scheduling recommendations to L&D nurses at Boston’s Beth Israel Deaconess Medical Center.

• Researchers trained Nao robot to learn about room scheduling in L&D –where nurses estimate when pts arrive in labor, length of labor, and whether C-sections or other procedures will be required.

• Nurses accepted the robot’s recommendations 90% of the time. Just to make sure the nurses weren't blindly accepting the robot's advice, the team also had the robot provide consciously bad feedback — which was also rejected at a 90% rate.

• One nurse involved said the robot allowed "for a more even dispersion of workload.” Another nurse thought the robot might help “new nurses [who] may not understand the constraints and complexities of the role.”

Robotics

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Page 18: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

“Despite the rapid uptake of robotic-assisted surgery, the usefulness of the technology has been questioned. For many procedures, particularly those in which other minimally invasive alternatives are already available, robotic-assisted surgery has not been shown to reduce complications or improve outcomes, but it is substantially more costly than other alternatives.” Wright JD et al., “Effect of Regional Hospital competition and Hospital Financial Status on the Use of Robotic-Assisted Surgery” JAMA Surg 2016;

151(7):612-620 (citations in original)

Robotics

18

“In general, blood loss, conversion rates, and complications were low but the operative

time was longer than the open procedures, whereas the duration of hospitalization was

shorter.” Papanikolaou, Surg Laparosc Endosc Percutan Tech. 2014 Dec;24(6):478-83

“has a significantly longer operation time…lower blood loss…shorter hospital stay. No statistical difference was noted based on the rate of overall postoperative complication, wound infection, bleeding, ileus and obstruction…” J Cancer Res Clin Oncol. (2016) Sep 20.

…evidence for a benefit of EBL, time to diet, similar perioperative complications and

oncological outcomes, but a longer operative time in RARC. Shen and Sun BMC, Urology (2016) 16:59

Page 19: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Robotics

• Serious Safety Events:

• Unintended laceration/puncture

• Bleeding/hemorrhage

• Thermal injury

• Positioning injuries

• Retained foreign bodies

• Infections—cleaning of equipment; maintaining sterile technique

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Root Causes:

• OR staff unfamiliar with equipment & robotic protocols

• Robotics requires new patterns of communication among OR team

• Equipment malfunction, loss of power, data interruption

• Inappropriate patient & case selection

• Increased surgical time

• Surgeon’s training & experience

• Exposes hospital’s credentialing & privileging process

Page 20: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

• Automated dispensing process

• Automated medication compounding (chemotherapy, hyperalimentation)

• Robotic delivery of prescriptions

Robotics Pharmaceutical Considerations

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Page 21: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Robotics ERM Risk List Operational Improved efficiency, credentialing and privileging, oversight and supervision

Clinical /Patient Safety Increased accuracy, lowered risk of contamination of products, anesthesia exposure increased

Strategic Organization can be seen as cutting edge

Financial High start up costs, but lower costs over time through improved inventory control, efficient use of

resources

Human Capital Decreased exposure to hazardous material, improved employee satisfaction through relieving staff

of mundane tasks., training and education

Legal / Regulatory Potential HIPAA exposure if systems hacked, need to assure compliance with FDA, OSHA

requirements

Technology Appropriate software/hardware, malware/viruses possible

Hazard back-up systems in event of electrical outages, computer crash, emergency management plans

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Page 22: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Resources on Robotics in Healthcare

Medical Articles

Juza RM, et al., “Training Current and Future Robotic Surgeons Simultaneously: Initial Experiences with Safety and Efficiency”, J Robot Surg 2014;

8:227-231.

Pradarelli JC et al., “Hospital Credentialing and Privileging of Surgeons: a Potential Safety Blind Spot”, JAMA 2015; 313(13): 1313-1314.

Salman, M et al., “Use, Cost, Complications, and Mortality of Robotic Versus Nonrobotic General Surgery Procedures Based on a Nationwide

Database”, Am Surg 2013; 79(6): 553-560.

Winder, JS et al., “Implementing a Robotics Curriculum at an Academic General Surgery Training Program: Our Initial Experience”, J Robotic Surg

2016; 10(3):209-213.

Wormer, BA, et al., “The First Nationwide Evaluation of Robotic General Surgery: a Regionalized, Small But Safe Start”, Surg Endosc 2014; 28(3):

767-776.

Wright, JD, et al., “Effect of Regional Hospital Competition and Hospital Financial Status on the Use of Robotic-Assisted Surgery”, JAMA Surg. 2016;

151(7): 612-620 (with Letter and Reply, appearing at JAMA Surg. 2016; 151(9): 883-884.

Accreditation Material

The Joint Commission. “Potential Risks of Robotic Surgery.” Quick Safety: An Advisory on Safety and Quality Issues. June 2014.

Credentialing Guidelines

American Urological Association, “Standard Operating Practices for Urologic Robotic Surgery” https://www.auanet.org/common/pdf/about/SOP-

Urologic-Robotic-Surgery.pdf (accessed 2/16/17).

Gross, ND et al., “Robotics in Otolaryngology and Head and Neck Surgery: Recommendations for Training and Credentialing,” A Report of the 2015

AHNS Education Committee, AAO-HNS

Robotic Task Force and AAO-HNS Sleep Disorders Committee, Head Neck 2016 April; 38(Suppl 1): E151-E158.

Zorn, KC et al., “Training, Credentialing, Proctoring and Medicolegal risks of Robotic Urological Surgery: Recommendations of the Society of Urologic

Robotic Surgeons”, J Urol 2009 Sept; 182(3): 1126-1132.

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Page 23: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Drones: Applications in Healthcare

• Federal Aviation Administration (FAA)

– 2012 FAA Modernization & Reform Act

– Small Unmanned Aircraft Rule (PART 107) June 21, 2016 http://www.faa.gov/uas/media/Part_107_Summary.pdf

– Recreational v Commercial

– Indoor v Outdoor

SOURCE Federal Aviation Administration; American Institute of Aeronautics and Astronautics Credit: Bart Jansen and Karl Gelles, USA TODAY

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Page 24: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Drones - What’s on the horizon? (Part 107) “COMMERCIAL DRONES” effective August, 2016 After dark flights only if drone’s anti-collision lights are visible for 3 miles Generally fly lower than 400 ft If higher than 400 ft must be within 400 ft of a structure Remain within sight of operator/observer in communication with operator at all times Operators undergo background check by TSA Register drone with the FAA = $5 fee Drone must have “aircraft markings” (an ID # that can be

traced back to owner) Before flying, inspect drone to make sure it’s safe May not fly drone over people (except your own team) Must avoid other flying craft May not exceed 100 miles an hour

2020 estimates - 30,000 commercial drones operating in US air space (source: GAO)

Spending on drones $89.5B within 10 years (source: FAA)

2015-2025 commercial drones to create 100K new jobs & $82B in economic activity (source: Basulto)

Drones: Applications in Healthcare

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Page 25: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Potential utilization of drones in healthcare Pharmaceuticals & medical supplies – Virginia clinic

Blood samples sent from field to lab - Johns Hopkins study 7/2015

Stony Brook University (SUNY) & Madagascar – blood samples 7/2016

Emergency Services (AED) – Delft University of Technology

https://www.youtube.com/embed/y-rEI4bezWc

India hospital testing organ deliveries

Rapid delivery of vaccines, meds & supplies to source of outbreaks

Indoor drones could deliver meds/supplies to the pt’s bedside

Homecare - deliver meds/supplies to pt’s home, transport blood samples

Falls - monitoring by drones surveying multiple rooms

Surveillance of property & wandering/elopement management

Drones: Applications in Healthcare

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Page 26: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Resources on Drones: Applications in Healthcare

• GAO, Unmanned Aircraft Systems: Comprehensive Planning and a Results-Oriented Training Strategy Are Needed to Support Growing Inventories, GAO-10-221 (Washington D.C.: March 26, 2010)

• Federal Aviation Administration (2014). Unmanned Aircraft Systems. https://www.faa.gov/about/office_org/headquarters_offices/apl/aviation_forecasts/aerospace_forecasts/2014-2034/media/Unmanned_Aircraft_Systems.pdf (accessed 2/16/17)

• Basulto, D. (2014). Graduates with drone skills are going to be in demand soon. Here’s why. http://www.washingtonpost.com/blogs/innovations/wp/2014/05/13/graduates-with-droneskills-are-going-to-be-in-demand-soon-heres-why/ (accessed 2/16/17)

• http://insideunmannedsystems.com/drones-deliver-healthcare/ (accessed 2/16/17)

• http://www.mayoclinic.org/medical-professionals/clinical-updates/trauma/medical-drones-poised-to-take-off (accessed 2/16/17)

• http://www.npr.org/sections/health-shots/2016/09/13/493289511/doctors-test-drones-to-speed-up-delivery-of-lab-tests (accessed 2/16/17)

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Page 27: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Enterprise Risk Management (ERM)

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ERM in healthcare promotes a comprehensive framework for making risk management decisions which maximize value protection and creation by managing risk and uncertainty and their connections to total value. (ASHRM’s ERM Definition)

Page 28: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

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ERM Looking into the windshield instead of the rear view mirror

Operational Clinical Financial Human Capital

Strategic Technology Legal & Regulatory Hazard

(ASHRM’s ERM work)

Macro and Micro Risk Assessments

Page 29: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

ERM Domains

Domain Description / Example

Operational inadequate/failed internal processes, people, systems that affect business

operations (p/p, infrastructure)

Clinical / Pt Safety delivery of care (HAC’s, Med errors, Falls)

Strategic direction of organization—brand, reputation, competition, failure to adapt to

changing times, health reform or customer priorities (M&A, Social Media)

Financial financial sustainability of organization (access to capital, external financial

ratings, litigation, payer mix)

Human Capital workforce (recruitment, retention, staff burnout)

Legal / Regulatory ACA, fraud & abuse, licensure, accreditation, product liability, management

liability, CMS COPs/CFCs

Technology machines, hardware, equipment, devices & tools, EMR

Hazard assets and their value (facility management, plant age, parking, lighting,

location, security, valuables, construction/renovation, earthquakes,

windstorms, tornadoes, floods, fires) (ASHRM’s ERM work)

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Page 30: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

ERM Process

1. Risk Assessment (Domains) – make your risk list with your team of experts in each domain

2. Risk Ranking (Inventory) based on likelihood, impact and velocity

3. Evaluate results & risk appetite

4. Decisions – next steps

5. Refresh risk assessment periodically

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Page 31: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

ERM Risk Assessment for Drones

You are the risk officer of a health system that includes hospitals & MD practices. The CEO has asked you to analyze drones to replace the courier service currently used to transport blood samples from MD offices to the hospital’s central lab.

Considerations:

– Do we need to analyze issues in all domains in this scenario?

– How will we measure exposure and then prioritize?

– Who gets involved to do the research, plan meetings, ask the tough questions?

– Who is the leader and reports findings?

– Who do we report the findings to and in what format?

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Page 32: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

ERM Risk Assessment for Drones

• Equipment management

• Visual line of sight – operator or visual observer

• Daylight operations

• Lights at night

• Frequency of operations

• Workplace safety (flying inside/outside)

• Supply chain/vendor management (owned v

rented)

• Education (how to use the drone & anything

specific that may need to be done with the vials,

packing in ice, shielding from sun, handling drone,

sending drone off & landing, securing drone upon

landing, operator or observer person training

• Backup plans for when drones are non-functional

• Keeping up with emerging evidence based

medicine in securing samples from destruction due

to environmental factors, timing, etc.

Operational

• Inaccurate results

& resultant

treatments

• Misdiagnosis

Clinical

• Access to capital

• Return on investment

– future use

Financial

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Page 33: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

ERM Risk Assessment for Drones

Human Capital

• Shifting couriers to other

assignments or eliminating need

and adding operator and observer

Technology

• Performing as expected

• Malfunctions

• Unprotected radio frequency with vulnerability to

intentional/unintentional interference

• GPS jamming and spoofing

• Velocity of change with industry science

Strategic

• Competition – speedier results and

treatment decisions with greater

provider/pt satisfaction

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Page 34: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

ERM Risk Assessment for Drones

Legal & Regulatory

• FAA compliance

• State and local regulations

• Insurance – product liability, GL, privacy,

cyber, workers’ comp, property – crash and

damage to others, owned/non-owned property,

the drone itself

• Privacy issues if drones have cameras

Hazard

• Biological issues if blood spills from

accident, etc.

• Weather related issues (rain, snow,

hail, wind) interruption to flight

• Interference by animals, foul play, etc.

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Page 35: Emerging Technology in Healthcare and Conducting an ERM ......According to Wohlers Report 2015, the 3D printing industry is expected to grow by more than 31% per year between 2014

Sample Risk Assessment Scales: Likelihood

35

Rating Description Characteristics

5 Almost Certain/

Already Occurring

• In System/Process: Knowledge-based decisions by trained

person

• Controls: Not working/may not exist

• Expected to Occur: Daily/weekly

4 Likely • In System/Process: Rule-based decisions by trained person

• Expected to Occur: Annually

3 Potential

• In System/Process: Automated or controlled by trained person

• Controls: Preventative, not detective

• Expected to Occur: Every 2 – 5 years

2 Unlikely

• In System/Process: Highly automated with validation and

monitoring

• Expected to Occur: Every 5 – 20 years

1 Rare • Controls: Preventative and detective

• Not expected to occur

(ASHRM’s ERM work)

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Sample Risk Assessment Scales: Impact

36

Rating Financial Patient Safety Operations/Process Reputational Legal/Regulatory

5

Critical

• Cash: Results in

<20 days cash on

hand

• Property damage:

>$250,000

• Key contract loss

• Loss of business

• Death/permanent

disability

• Event:

Suicide/rape/ child

abduction

• Significant labor relations

event

• Workplace safety:

multiple lost time

injuries/recordable

incidents

• PHI/PI Breach: >100

• Significant brand

impairment; loss of

significant market

share

• Sustained, negative

media coverage

• Customer satisfaction:

<85%

• Loss of license

• State/Federal

investigation

4

Major

• Cash/expense:

$150,000

• Property damage:

$100,000 - 250,000

• Additional

unexpected capital

required

• Substantiated

boundary or code of

conduct incident

• Major or critical

health incident

• Non-compliance

with Standard of

Care

• Loss/significant turnover

of key personnel

• IT systems disruption

• Workplace safety: Lost

time and recordable

incidents

• PHI/PI Breach: <100

• Temporary but

significant negative

media coverage

• Customer satisfaction:

85-88%

• State/Federal

inquiry

(not investigation)

3

Moderate

• Cash/expense:

$50,000

• Property damage:

$10,000–100,000

• Upward trend in

minor health

incidents

• No clinical

continuity

• Loss of or increased

turnover in key positions

• Operational disruption or

increased costs due to

regulatory change

• Negative media

mention (state)

• Customer satisfaction:

88-90%

• Corporate non-

compliance with

financial impact

• Insurance access

implications

2

Minor

• Cash/expense:

$10,000

• Property damage:

<$10,000

• Minor health

incidents; patient

not knowledgeable

of failure

• Distraction in employee

base

• Customer satisfaction:

90–94%

• Minor violations

(e.g., auto)

1

Insignificant

• Insignificant

property damage or

impact to cash

• No impact on the

delivery of care

• Customer satisfaction:

>95%

(ASHRM’s ERM work)

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Risk Scoring - VELOCITY

RATING

VELOCITY

The rating number matches with the timeframe that most appropriately represents the time it would take the risk event to

reach the defined impact level.

5

Immediate

4 1-2 years

3 2-5 years

2 5-10 years

1 > 10 years

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Sample Risk Assessment Scales: Velocity

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Risk Ranking Formula

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2

(Likelihood + Velocity) x Impact = Risk Score

(a value 1 to 5) (a value 1 to 5) (a value 1 to 5)

(1 + 1) = 2 x 1 = 2 (lowest possible score)

(5 + 5) = 10 x 5 = 50 (highest possible score)

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Risk Inventory (DRONES) Domain

Likelihood (1-5)

Velocity (1-5)

Impact (1-5)

Risk Score

Drones must be used within visual line of sight based on regs (need an operator or visual observer) Reg/Tech 5 5 5 50

Biohazard from blood spill Hazard 3 5 5 40 Weather related issues (rain, snow, hail, wind) that interrupt drone flights Hazard 5 5 4 40

Inaccurate test results & subsequent treatment Clinical 4 5 4 36 Keeping up w/ emerging evidence based medicine for blood samples & potential for compromise due to env't factors, timing, etc. Operational 4 4 4 32

Backup plans for downtime when drones are non-functional Operational 4 4 3 24 Access to capital for drone technology (UAVs, control station, data links, telemetry, communications & navigation equipment) Financial 3 4 3 21 Training (using the drone and anything special that may need to be done with the labs, packing in ice, shielding from sun, security of drone, handling drone, sending drone off and landing, securing drone upon landing, the operator or observer roles) Operational 3 4 3 21 Shifting couriers to other assignments or eliminating jobs (adding operator and observer)

Human Capital 3 5 2 16

Return on Investment (future use for other tasks) Financial 3 3 2 12

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Risk Inventory

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Risk Appetite

QUESTIONS: Risk Appetite & Decisions

– Is there more value than risk?

– Is there more value creation than protection potential?

– Can risks identified be mitigated easily?

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ERM Resources

• University of California ERM resources http://www.ucop.edu/enterprise-risk-management/resources/sample-erm-documentation.html

• Milliman Risk Institute Survey, Oxford Economics. (August 2014). Creating value through enterprise risk management. http://us.milliman.com/uploadedFiles/insight/2014/survey-creating-value-erm.pdf

• ASHRM - ERM Quick Reference Tool, ERM for Boards and Trustees: Leveraging the Value, White Paper - ERM: A Framework for Success, ERM Readiness Assessment Tool, Playbook: An Implementation Guide for Healthcare Professionals, (3) Pearls for ERM: The Foundation, Applying ERM, Integrating ERM into the Healthcare Culture, ERM Certificate Program http://www.ashrm.org/resources/ERM

• ERM: From Incentives to Controls – James Lam

• Harvard Business Review

• Association of Healthcare Internal Auditors (AHIA) http://www.ahia.org

• Healthcare Financial Management Association (HFMA) http://www.hfma.org

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Legal notice

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