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13th AMC Security & Privacy Conference June 12, 2017 Tatiana Melnik Melnik Legal PLLC [email protected] 734-358-4201 Tampa, FL Ryan Vlcko McLaren Health Care Corporation [email protected] 810-342-1174 Flint, MI

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Page 1: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

13th AMC Security & Privacy Conference June 12, 2017

Tatiana Melnik

Melnik Legal PLLC

[email protected]

734-358-4201

Tampa, FL

Ryan Vlcko

McLaren Health Care Corporation

[email protected]

810-342-1174

Flint, MI

Page 2: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

I. A Few Words About McLaren

II. Why the Focus on Vendors?

III. Tips and Lessons from the Trenches

A. The “Right” Process

B. Risk Mitigation

Business Associate Agreements

Insurance

C. The Break Up and Holding Vendors

Accountable

Outline

Page 3: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Headquartered in Flint, Michigan

o Fully integrated health network 12 hospitals

operates Michigan’s largest network of cancer centers and providers

ambulatory surgery centers, imaging centers, home health and hospice providers, retail medical equipment showrooms, and pharmacy services

an employed primary care physician network

commercial and Medicaid HMOs covering more than 250,000 lives

a wholly owned medical malpractice insurance company

Page 4: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Key Operational Statistics (2015)

Discharges 102,597

ER Visits 405,098

Surgeries 92,052

Births 6,057

Ambulatory Visits 3.2 Million

Home Care Visits 175,516

Hospice Days 79,994

Licensed Beds 3,096

Community Benefit $201 Million

Employees 22,000

Days of Inpatient Care 461,882

Contracted Providers 40,317

Annual Payroll $1.2 Billion

Net Revenue $3.5 Billion

Page 5: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company
Page 6: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Healthcare = Vendors

© Continua Health Alliance, http://continuaalliance.org

Page 7: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Vendors Create Risks

• Processed and analyzed

over 100 terabytes of

traffic daily

• 49,917 unique malicious

events

• 723 unique malicious

source IP

Page 8: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Breaches Disclosed to OCR: Top 10 Based on Patient Impact

Vendors Create Risks

Entity Name Type No. Patients

Impacted

Date

Reported

Cause

Anthem, Inc. Health Plan 78,800,000 03/13/2015 Hacking/IT Incident

Premera Blue Cross Health Plan 11,000,000 03/17/2015 Hacking/IT Incident

Excellus Health Plan, Inc. Health Plan 10,000,000 09/09/2015 Hacking/IT Incident

Science Applications

International Corp.

Business Associate 4,900,000 11/04/2011 Loss

Univ. Cal. - LA Provider 4,500,000 07/17/2015 Hacking/IT Incident

Community Health

Systems

Business Associate 4,500,000 08/20/2014 Theft – Network

Server

Advocate Health and

Hospitals Corp.

Provider 4,029,530 08/23/2013 Theft – Network

Server

Medical Informatics

Engineering

Business Associate 3,900,000 07/23/2015 Hacking/IT Incident

Banner Health Provider 3,620,000 08/03/2016 Hacking/IT Incident

Newkirk Products, Inc. Business Associate 3,466,120 08/09/2016 Hacking/IT Incident

Page 9: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Breaches Disclosed to OCR: Top 10 Based on Patient Impact

Vendors Create Risks

Entity Name Type No. Patients

Impacted

Date

Reported

Cause

Anthem, Inc. Health Plan 78,800,000 03/13/2015 Hacking/IT Incident

Premera Blue Cross Health Plan 11,000,000 03/17/2015 Hacking/IT Incident

Excellus Health Plan, Inc. Health Plan 10,000,000 09/09/2015 Hacking/IT Incident

Science Applications

International Corp.

Business Associate 4,900,000 11/04/2011 Loss

Univ. Cal. - LA Provider 4,500,000 07/17/2015 Hacking/IT Incident

Community Health

Systems

Business Associate 4,500,000 08/20/2014 Theft – Network

Server

Advocate Health and

Hospitals Corp.

Provider 4,029,530 08/23/2013 Theft – Network

Server

Medical Informatics

Engineering

Business Associate 3,900,000 07/23/2015 Hacking/IT Incident

Banner Health Provider 3,620,000 08/03/2016 Hacking/IT Incident

Newkirk Products, Inc. Business Associate 3,466,120 08/09/2016 Hacking/IT Incident

Page 10: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Vendors Create Risks

Source: Ponemon Institute, 2016 Cost of a

Data Breach Study (US only data)

Page 11: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Vendors Create Risks

Source: Ponemon Institute, 2016 Cost of a

Data Breach Study (US only data)

Page 12: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

I. A Few Words About McLaren

II. Why the Focus on Vendors?

III. Tips and Lessons from the Trenches

A. The “Right” Process

B. Risk Mitigation

Business Associate Agreements

Insurance

C. The Break Up and Holding Vendors

Accountable

Outline

Page 13: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Is there a “right” process for vendor management?

o The “right” process is….

The one that mitigates the most risk for the company?

The one that closes transactions fastest so that we can go back to treating patients?

The one you can get your team to follow?

o Are these all the same goals? Mutually exclusive?

The “Right” Process

Page 14: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

The “Right” Process

Not Defined

• No process defined

• Ad hoc and inconsistent

Defined & Established

• Consistent but unstructured approach

• Document and detailed, but not measured or enforced

Continuous Improvement

• Ongoing monitoring, measuring, and process improvements

• Best practices and benchmarking

Page 15: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o What is McLaren’s process?

o How does McLaren determine

what contracts get reviewed?

“Importance” of the vendor?

Value of the transaction?

Risk to the organization?

Term of commitment?

Are these all the same goals? Mutually

exclusive?

The “Right” Process

Page 16: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Successful vendor management

is a Team Sport

Business Lead

Purchasing

Security Officer

Compliance

Legal

Risk Management

o But, who is the Coach?

The “Right” Process

Page 17: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Vendor Due Diligence

Vendor security questionnaire

Audit – self-certify or “disinterested” third party vendor?

Certificate of insurance How much is an indemnification provision from

a judgment proof company worth?

General online search or search on Shodan?

Check OCR wall of shame

o Can due diligence be done on every vendor?

Vendor Risk Mitigation

Page 18: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Business Associate Agreements vs.

Master Services Agreements – what

do they say about:

Reporting

Data breach insurance

Using off-shore vendors?

Damages caps?

Data use

Vendor Contracting

Page 19: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Secondary Uses of Data Data is the new commodity

Many vendors want the rights to share data outside the specific contract relationship to provide “additional services” . . . to whom?

Permissible under HIPAA? Maybe… some say yes, some say no, some say

depends on who is doing the de-identification…

Specific analysis required

How does this impact --- Indemnification?

Damages caps that are set at “the fees received during the 12 months prior to when the claim arose”?

Vendor Contracting

Page 20: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Business Associate Agreements Scope of authorization to use data

Who determines when there is a “breach”? Is there a requirement to notify in the event of a “security

incident”

Timeline must be considered, particularly if organization is operating in multiple states or servers a patient population pool that crosses state lines

Who determines when notice is required and who sends that notice? Watch your insurance policy on this one…

Is the vendor required to encrypt data?

Who pays for responses to a subpoena?

Caps on liability? Should there be?

Vendor Contracting

Page 21: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Indemnification Mutual or not?

Consider - Should a customer be indemnifying the vendor for “Vendor’s negligence”?

“acts, omissions, or negligence ” vs. “gross negligence” vs. “willful misconduct”

Property damage/personal injury

Property rights infringement claims (patent, trademark, copyright, etc.)

Data breaches, security incidents, and loss of data

Vendor Contracting

Page 22: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Confidentiality Clause If the hospital is not permitted to disclose “the terms of

this Agreement”, what happens if it has to file for a Certificate of Need? If there is an accreditation audit?

What happens post-termination? Can a hospital really “destroy all Confidential Information”?

o Rep and Warranty for Security “. . . develop, implement, and maintain commercially

reasonable physical, technical and administrative safeguards”

“. . . has security protocols that meet or exceed compliance with any required laws, regulations, and the SOC 1 and SOC 2 Type II standards, which will be audited on an annual basis by a disinterested third-party auditor. Vendor will provide to Customer a copy of such audit report upon written request.”

Vendor Contracting

Page 23: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o A data breach is inevitable…

o Data breach insurance = Risk reduction

o But, how do insurance companies try to

reduce risks?

Insurance

Page 24: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o A data breach is inevitable…

o Data breach insurance = Risk reduction

o But, how do insurance companies try to

reduce risks?

Insurance

Page 25: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o A data breach is inevitable…

o Data breach insurance = Risk reduction

o But, how do insurance companies try to

reduce risks?

Insurance

They try to cancel your policy ….

Columbia Casualty Co. v. Cottage Health Systems

(C.D. California) – Filed May 7, 2015 (first case of its

kind) • Columbia paid $4.125M to settle a class action stemming

from a breach (32,500 records disclosed; settlement class of

50,917)

• “The complaint alleges that the breach occurred because

Cottage and/or its third-party vendor, INSYNC Computer

Solution, Inc. (“INSYNC”), stored medical records on a

system that was fully accessible to the internet but failed to

install encryption or take other security measures to protect

patient information from becoming available to anyone who

‘surfed’ the internet.”

• Columbia sought to recoup funds paid

Page 26: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o Read the policy…

o Some policies exclude coverage for damages that arise out of activity that is contrary to your

“Privacy Policy” … What does your Privacy Policy say exactly?

for agents or vendors where there are no contracts

for losses if the data is stored “in the cloud”

for work done by “independent contractors”

if laptops are not “encrypted” (using FIPS 140-2 validated encryption algorithm)

o Some policies require notification to the policy as a condition of coverage….

o How much is an indemnification provision from a judgment proof company worth?

Insurance

Page 27: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

o A few final thoughts learned from when

things went wrong…

The Break Up

Page 28: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

This slide presentation is informational only and was prepared to provide a brief overview of vendor management considerations in the healthcare industry. It does not constitute legal or professional advice.

You are encouraged to consult with an attorney if you have specific questions relating to any of the topics covered in this presentation.

Disclaimer

Page 29: 13th AMC Security & Privacy Conference · 2017. 6. 12. · Melnik Legal PLLC tatiana@melniklegal.com 734-358-4201 Tampa, FL ... a wholly owned medical malpractice insurance company

Tatiana Melnik Attorney

Melnik Legal PLLC Based in Tampa, FL

734.358.4201

[email protected]

Ryan Vlcko Staff Attorney

McLaren Health Care Corporation

Based in Flint, MI

810.342.1174

[email protected]

Questions