Long-Term Care and the Law Analyzing and Minimizing HIPAA/HITECH Risks for Post-Acute Care Providers February 20, 2013 Diane Felix, Anthony Munns, Suzanne.

Long-Term Care and the LawAnalyzing and Minimizing HIPAA/HITECH Risks for Post-Acute Care Providers

February 20, 2013Diane Felix, Anthony Munns, Suzanne Sheldon

Analyzing and Minimizing HIPAA/HITECH Risks for Post-Acute Providers – Felix/Munns/Sheldon

Myth #1 – The government is only after the big guys and the huge breaches.


Reality:• 1 stolen lap-top with unencrypted PHI of 441

hospice patients = $50,000 penalty • 5-physician cardiothoracic practice sending

unencrypted PHI via emails + using publicly-accessible appointment calendar = $100,000 penalty

• 41-bed hospital with 1 stolen lap-top with unencrypted PHI = $1,500,000 penalty


Myth #2 – We don’t have an EMR system, so we don’t need to worry about ePHI security.


Reality:

•If you have PHI on laptops or other portable devices, or staff texting or emailing information that includes PHI, then security requirements are an issue for you.


Myth #3 – Business Associate Agreements are just forms we need to get signed and have in our files to satisfy the government.


Reality:

•The terms of those agreements – or what’s not there – could cost you big time if there is a data breach.


Points to ponder:• Size doesn’t matter.• Loss or theft of laptop = likely OCR

investigation.• Failure to perform risk analysis + failure to

implement policies and procedures + breach = likely big penalty.

• Encryption is a critical factor.• Increased penalties under HIPAA Final

Omnibus Rule have substantially increased your risks.

PRIVACYA Brief Overview



Key Concepts

•Covers protected health information (PHI) in any form

•Applies to covered entities (health care providers, health plans and health care clearinghouses) and business associates

•Patient rights•Civil and criminal liabilities


Protected Health Information

•PHI: Individually identifiable health information (IIHI) that is:▫Transmitted by electronic media;▫Maintained in electronic media; or▫Transmitted or maintained in any other

form or medium


HIPAA Privacy Rule

•Requires Covered Entities (CEs) and Business Associates (BAs) to have safeguards in place to ensure the privacy of PHI

•Denotes under what circumstances a CE or BA may use or disclose PHI

•Gives individuals the right to examine, request a copy and make corrections to their PHI


HIPAA Basics - cont’d

•Minimum Necessary Rule: When using, disclosing or requesting PHI, CEs and BAs must make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure or request


USE and DISCLOSURE• Required Disclosures

▫ To the individual when requested▫ To HHS in matters relating to the investigation or

determination of compliance with the Privacy Rule• Permitted Disclosures

▫ Individual (with some exceptions)▫ TPO (Treatment/Payment/Health Care Operations)▫ Opportunity to Agree or Object▫ Public Policy▫ Incidental (as long as comply with minimum necessary

requirements and used reasonable safeguards)▫ Limited Data Set▫ Authorized


BREACH

•An impermissible use, acquisition or disclosure that compromises the security or privacy of the protected health information.

•Before HFOR, a breach was defined to “compromise security or privacy” only if it posed a “significant risk of financial, reputational, or other harm” to the individual.


BREACH FINAL RULEFINAL RULE: An impermissible use or disclosure of PHI is presumed to be a breach and notification is required unless the CE or BA demonstrates there is a low probability that the PHI was compromised.

“Low probability” must be demonstrated and documented with a risk assessment.

Burden of proof of “low probability” lies with the CE and/or BA, as appropriate.


BREACH RISK ASSESSMENT

A risk assessment must include at least the following factors:

▫Nature and extent of the PHI involved, including types of identifiers and chance of re-identification

▫The unauthorized person who used the PHI or to whom the disclosure was made

▫Whether the PHI was actually acquired or viewed

▫The extent to which the risk to the PHI has been mitigated


BREACH RISK ASSESSMENT – cont’d

• HHS expects the risk assessments to be “thorough, completed in good faith and for the conclusions reached to be reasonable”

• A CE or BA may, at their discretion, provide notifications without performing the risk assessment

• HHS plans to provide additional guidance in the future for the handling of “frequently occurring” situations


BREACH NOTIFICATION RULE• CEs must notify both the U.S. Department of Health

& Human Services (HHS) + the affected individual of the loss, theft, or other impermissible use or disclosure of PHI

• Breaches that affect 500 or more individuals must be promptly reported to the media and HHS▫Breaches that affect 500 or more are publicly reported

on the HHS/Office of Civil Rights (OCR) website

• OCR has discretion to investigate even where there’s no willful neglect


BREACH NOTIFICATION REQUIREMENTS• Individual Notice

▫ In written form by first-class mail, or email if individual has agreed to receive communications electronically

▫ Within 60 days of the discovery of the breach

• Media Notice▫ If breach affects >500 residents of a State or Jurisdiction▫ No later than 60 days

• Notice to the Secretary▫ Via the HHS web site

No later than 60 days if > 500 If < 500, may notify on an annual basis


TOP 5 ISSUES ININVESTIGATED CASES

1. Impermissible uses and disclosures of protected health information

2. Lack of safeguards of protected health information

3. Lack of patient access to their protected health information

4. Uses or disclosures of more than the minimum necessary protected health information

5. Lack of administrative safeguards of electronic protected health information


Penalties – 4 Tiers1. If CE/BA didn’t know of a violation, and wouldn’t have known

by exercising due diligence = $100 - $50,000 per violation

2. If CE/BA knew, or with “reasonable diligence” would have known an act or omission violated requirement, but did not act with “willful negligence” = $1,000 - $50,000 per violation

3. If there was “conscious, intentional failure or reckless indifference to the obligation to comply with the provision violated,” but it was corrected = $10,000 - $50,000 per violation

4. If there was “conscious, intentional failure or reckless indifference to the obligation to comply with the provision violated,” and it was not corrected = $50,000 per violation


Factors In Penalty Amount

• HHS will determine penalty amounts on case-by-case basis and may consider factors such as:

▫Number and extent of violations, which may include # of individuals affected, and time period involved.

▫Nature and extent of harm resulting from violation, which may include whether violation caused physical or financial harm, harm to reputation, or hindered individual’s ability to obtain healthcare.


Penalty Amount – cont’d▫CE/BA’s prior compliance, which may include

whether:

Current violation is same or similar to previous “indications of noncompliance”

Correction of previous “indications of noncompliance”

Security



Basic Security Requirements• Designate a security officer (can also be the

privacy officer)• Implement policy on workplace use and

dissemination of PHI• Implement policy on workstation use, procedures

for storage and disposal of PHI• Implement procedures for data backup and

disaster recovery• Develop and implement data access control

procedures


Basic Security Requirements – cont’d

• Implement an audit trail for access to PHI• Sign and amend contracts with business

associates to protect the security of PHI• Provide security awareness training to all

designated personnel• Implement technical security mechanisms to

prevent unauthorized access• Establish a reporting and response system for

security violations


Security Rule Implementation Specifications

•Safeguards identified as either “Required” or “Addressable”

▫ “Addressable” doesn’t = optional. Choices are:

Implement it, Implement alternative measure(s) that accomplish

purpose, OR Don’t implement anything – but must have written

documentation of factors considered and results of risk assessment.


Security Standards Matrix - examplesStandards Sections

Implementation Specifications(R) = Required, (A) = Addressable

Administrative Safeguards

Security Management Process

164.308(a)(1)

Risk Analysis (R)Risk Management (R)Sanction Policy (R)Information System Activity Review (R)

Assigned Security Responsibility

164.308(a)(2) (R)

Workforce Security 164.308(a)(3Authorization and/or Supervision (A)Workforce Clearance Procedure Termination Procedures (A)

Information Access Management

164.308(a)(4)Isolating Healthcare Clearinghouse Function (R)Access Authorization (A) Access Establishment and Modification (A)

Physical Safeguards

Facility Access Controls 164.310(a)(1)

Contingency (A)Facility Security Plan (A)Access Control and Validation Procedures (A)Maintenance Records (A)

Workstation Use 164.310(b) (R)

Workstation Security 164.310(c) (R)

Device and Media Controls 164.310(d)(1)

Disposal (R)Media Re-use (R)Accountability (A)Data Backup and Storage (A)


Factors to take into account in deciding which security measures to use• Size, complexity, and capabilities of the Covered

Entity or Business Associate;• CE’s and BA’s technical infrastructure,

hardware, and software security capabilities;• Costs of security measures;• Likelihood and impact of potential risks to ePHI;

and• Preamble to the Security Rule states: “Cost is

not meant to free covered entities from this responsibility.”


Is Encryption Required? No, but...

•Encrypted data is considered “secure” under HIPAA, and thus is exempted from breach notification requirements.

•Consider:▫BitLocker – supplied with MS-Windows 7

and later▫Use HTTPS or secure messaging systems▫Use encrypted USB drives or block their

use


Useful information• Advanced Encryption Standard (AES) is a

specification for the encryption of electronic data established by the U.S. National Institute of Standards and Technology (NIST)

• For more information about encryption, see NIST Special Publication 800-111, Guide to Storage Encryption Technologies for End User Devices, National Institute of Standards and Technology, (Nov., 2007)


Risk Analysis• Scope – potential risks and vulnerabilities to

the confidentiality, availability and integrity of all e-PHI that an organization creates, receives, maintains, or transmits.

• Data Collection – identify where e-PHI is stored, received, maintained or transmitted.

• Identify & Document Potential Threats and Vulnerabilities.

• Assess Current Security Measures.


Risk Analysis

•Determine Likelihood of Threat Occurrence.

•Determine Potential Impact of Threat Occurrence.

•Determine the Level of Risk.•Finalize Documentation.•Periodic Review & Updates to the Risk

Assessment.

Vendor Management Programs



•Even before HFOR, there have been frequent reminders of how badly things can go wrong when CEs fail to do due diligence with vendors who have access to PHI, and when BA Agreements are inadequate – or missing altogether.


Four Massachusetts pathology practices were fined $110,000 for failing to have appropriate safeguards in place regarding PHI provided to a billing firm.•A newspaper photographer for the Boston

Globe found medical records at a recycling station after dropping off his own trash.


Kaiser Permanente gave patient medical records to a couple to store

• The couple’s document storage firm kept the records in a warehouse shared with a party rental business, and in a Ford Mustang.

• Kaiser’s lawsuit against the couple claimed that the couple left two computer hard drives in their garage with the door open.

• State and Federal agencies are investigating.


Costs of vendors behaving badly can be crippling

• Aside from the costs to an organization’s reputation, the costs of investigating, and the notification costs, there are the costs of mitigating the effects of a data breach.

▫For example, credit monitoring at $20 per month, per individual, means that if a stolen laptop with unencrypted data has PHI for only a 100 individuals, that’s still $24,000 for a year’s worth.


Changed obligations for BAs and independent contractors under HITECH and HFOR make adequate vendor management even more important.

• Business Associates are now directly responsible for compliance with HIPAA as modified by HITECH, and have direct responsibility for penalties.

• The definition of Business Associate has been expanded to cover:▫ Subcontractors of BAs.▫ Entities that create, receive, maintain, or transmit PHI

in connection with services provided to a CE.• The “primary” BA is required to obtain “satisfactory

assurances” from subcontractors that the subcontractor will appropriately safeguard the PHI.


Examples of “Due Diligence” Questions to Consider

•Do you or the vendor have sufficient resources or insurance coverage to cover the costs that will be involved in responding to any breach?

•Does your BA Agreement make clear how quickly notification must be made to the CE of a suspected breach, to whom the notice must go, and what information must be provided?


Questions- cont’d

•Is the vendor’s access to and use and disclosure of PHI limited to the minimum necessary to accomplish the specific purpose?

•Is there any mechanism for monitoring compliance by the vendor with HIPAA/HITECH requirements?

•Have the responsibilities/liabilities of subcontractors been taken into consideration?

Preparing for OCR HIPAA Compliance Audits



• The Security Rule details areas that require the following of CEs:

▫Policies▫Procedures▫Documentation (think audit trail)

• The first institution audited – Atlanta’s Piedmont Hospital – was presented with a list of 42 items that HHS wanted within 10 days.


Piedmont was asked for 24 specific policies and procedures, including:

• Establishing and terminating users' access to systems housing ePHI.

• Emergency access to electronic information

systems. • Inactive computer sessions (periods of inactivity). • Recording and examining activity in information

systems that contain or use ePHI.


• Risk assessments and analyses of relevant information systems that house or process ePHI data.

• Employee violations (sanctions). • Electronically transmitting ePHI.

• Preventing, detecting, containing and correcting security violations (incident reports).

• Regularly reviewing records of information

system activity, such as audit logs, access reports and security incident tracking reports.


Section 13411 of the HITECH Act requires HHS to provide for periodic audits to ensure that covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards.


• To implement this mandate, OCR piloted a program to perform 115 audits of covered entities to assess privacy and security compliance.

• KPMG was then retained to perform the audits.

• Audits conducted during the pilot phase began November 2011 and concluded in December 2012.

• So far, all the audits have been of Covered Entities.


The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate.

OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits. The entire audit protocol is organized around modules, representing separate elements of privacy, security, and breach notification.

The combination of these multiple requirements may vary based on the type of covered entity selected for review.


The audit protocol covers:

• Privacy Rule requirements: ▫ notice of privacy practices for PHI,▫ rights to request privacy protection for PHI,▫ access of individuals to PHI,▫ administrative requirements,▫ uses and disclosures of PHI,▫ amendment of PHI, and▫ accounting of disclosures.

• Security Rule requirements for administrative, physical, and technical safeguards.

• Requirements for the Breach Notification Rule.


There are 169 audit tests: Privacy has 81, Security 78 and Breach 10.

So far the protocol has not been updated for the HIPAA Omnibus Rule.


Speakers’ Contact Information

Diane E. Felix, J.D. - PartnerArmstrong Teasdale LLP7700 Forsyth Blvd., Suite 1800St. Louis, MO 63105(314) 342.8001(314) 612.2243 (fax)[email protected]

Anthony J. Munns, CISA, FBCS, CITP - Partner, Risk ServicesBrown Smith Wallace LLC1050 N. Lindbergh Blvd.St. Louis, MO 63132314.983.1297 Direct / 314.614.6582 Cell314.983.1200 Main / 314.983.1300 [email protected]

Suzanne Sheldon, J.D. – Director of Risk Management and Corporate ComplianceLutheran Senior Services1150 Hanley Industrial Ct.St. Louis, MO 63144(314) 446.2577(314) 446.2550 (fax)[email protected]

Long-Term Care and the Law Analyzing and Minimizing HIPAA/HITECH Risks for Post-Acute Care Providers February 20, 2013 Diane Felix, Anthony Munns, Suzanne.

Documents

hipaahitech risks

phi slide

postacute care providers

penalty slide

medium slide

unencrypted phi

privacy of phi

suzanne sheldon slide