Health Insurance Portability Accountability Act HIPAA 1996 HITECH

Health Insurance Portability & Accountability Act (HIPAA) 1996 HITECH 2009 Introduction Privacy Rule Security Rule

Acknowledgments Material is from: n HIPAA Compliance, Carlene Dalgleish n Legal Issues in Information Security, Joanna Lyn Grama n Health Care Reform in the United States: HITECH Act and HIPAA Privacy, Security, and Enforcement Issues, Amy E Kempfert, Benjamin D Reed Author: Susan J Lincke, Ph. D Univ. of Wisconsin-Parkside Contributor: Misty Lowery Reviewers: Funded by National Science Foundation (NSF) Course, Curriculum and Laboratory Improvement (CCLI) grant 0837574: Information Security: Audit, Case Study, and Service Learning. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and/or source(s) and do not necessarily reflect the views of the National Science Foundation.

HIPAA n n Introduced by Senators Edward Kennedy & Nancy Kassebaum Portability: Workers can continue health care between different employers ¨ Group insurance cannot reject, not renew, or charge higher premiums of certain individuals ¨ Simplify administration by creating a health care transaction standard n Accountability: ¨ Penalties for non-compliance ¨ Tax provisions

HIPAA Titles n n n Title 1: Health Care Insurance Access, Portability, and Renewability Title 2: Preventing Health Care Fraud & Abuse, Administrative Simplification, Medical Liability Reform Title 3: Tax-related Health Provisions ¨ n n Standardizes medical savings accounts Title 4: Application and Enforcement of Group Health Insurance Requirements Title 5: Revenue Offsets ¨ Defines how employers can deduct company-owned life insurance premiums from income tax

Title 2 Has Three Rules Transactions, Code Sets, and Identifiers: Standards for electronic transmission ¨ Electronic Data Interchange: Standardized records for health care transactions The Privacy Rule: Standard for Privacy of Individually Identifiable Health Information The Security Rule: Security Standard for electronic patient health

Reasons for Legislation n n Records of patients or insurance claims made publicly available by accident Email reminder to take Prozac sent to 600 (not blind cc’d) Woman fired from job after positive review but expensive illness 35% of Fortune 500 companies admitted checking medical records before hiring or promoting People avoid using insurance when they have AIDS, cancer, STD, substance abuse or mental illness

Medical Identity Theft: When a person’s name and other parts of his/her medical identity are stolen for the purpose of getting medical services and goods.

Medical Identity Theft: Problems: n Medical info is for wrong person ¨ Inaccurate health records ¨ Wrong diagnosis ¨ Fatal treatments n Imposter claims health care ¨ Medical Insurance Fraud ¨ Inaccurate Credit History: Bills sent elsewhere

Medical Identity Thieves: Who can commit this crime? n n n Computer hackers Members of organized crime rings Health care providers (doctor’s, dentists, hospital employees)

Business Challenges Facing the Health Care Industry n n Hospital computer systems contain notes from hospital employees and primary care physicians. Health Insurance Companies collect and compile patient data from different providers. Organizations MUST maintain the security of computer systems that hold health data.

Breach Notification Laws The Oregonian, May 2006 In one of Oregon’s largest security breaches, Providence Health System disclosed that a burglar stole unencrypted medical records on 365, 000 patients kept on disks and tapes left overnight in an employee’s van State Laws, called Breach Notification Laws require CEs to notify patients when their PHI has been breached If data is encrypted and laptop is lost, notification is not required This often applies to any industry that uses personal information, such as Social Security Numbers

HITECH: Health Information Technology for Economic and Clinical Health Act (2009) Breach Notification Rule n Introduced notification requirements n PHI shall be encrypted in a way that is approved by HHS. n PHI shall be shredded or destroyed and disposed of properly. n Specifies how CE/BA should notify individuals and agencies if a breach of information occurs

Criminal Penalties for HIPAA $ Penalty Imprisonment Offense Up to $50 K Up to one year Wrongful disclosure of individually identifiable health information Up to $100 K Up to $500 K Up to 5 years Up to 10 years …committed under false pretenses … with intent to sell, achieve personal gain, or cause malicious harm Then consider bad press, state audit, state law penalties, lost claims, …

HITECH Act (2009) Each Max $ Per Violation Year CE/BA exercised reasonable diligence but did not learn about violation $100$50 k $1. 5 Million Violation is due to reasonable cause $1 k$50 k $1. 5 Million CE/BA demonstrated willful neglect but corrected violation $10 k$50 k $1. 5 Million CE/BA demonstrated willful neglect and took no corrective action $50 k $1. 5 Million Penalties are prohibited if problem is corrected within 30 days and no willful neglect Penalties pay for enforcement and redress for harm caused

Health Care Organization Covered Entities (CE) Health plan (e. g. , HMO, PPO) Standard bills/records Health care Clearinghouse Standard bills/records Nonstandard bills/records Health Care Provider (e. g. , doctor, hospital)

Health Care Organization Business Associates (BA) Works Covered Entities (CE) Health plan for Performs: Claims Processing Transcription Billing Data Analysis Independent organization Work involves health info Not bank or post office Health care Clearinghouse Health Care Provider

Protected Health Information (PHI) Health Information Relates to Physical or Mental health or past/present/ future payment Identifiers Name SSN city or county zip code phone or fax medical record # fingerprint If YOU had AIDS, how could such identifiers Identify you? Individually Identifiable Health Information Created or maintained by CE or BA Protected Health Information (PHI) Covered by HIPAA & HITECH

Treatment, Payment & Health Care Operations (TPO) Treatment Payment Provision & coordination of health care among health care providers, including referral Any activities involved in compensation for health care: billing, determining coverage or eligibility analyzing services $ Health Care Operations Administrative functions related to health care: financial or legal or quality improvement, training, certification, case mgmt, business planning

HIPAA Standard Transactions Health plan (e. g. , HMO, PPO) n Enrollment or Disenrollment into Health Plan n Health Plan Premium Payment n Health Plan Eligibility Inquiry n Certification & Authorization of Referral n Health Care Claim Status Request n Health Care Claim Payment Plan Sponsor (Employer) n Certification & Authorization of Referral Health Care Provider (e. g. , doctor, hospital)

The Genetic Information Nondiscrimination Act of 2008 n Protects against some types of genetic testing discrimination. ¨ Insurance companies can’t make eligibility decision based on genetic testing results. ¨ Insurance companies can’t base cost of premiums on genetic testing results. ¨ Employers can’t hire, fire or make job decisions based on the use genetic testing. ¨ Employers/Health Insurance Plans can not requiring genetic testing.

The HIPAA Privacy Rule

Privacy Rule: Develop Policies CE/BAs shall: n Develop policies, procedures, and standards for how it will adhere to Privacy Rule. How will CE/BA: ¨ use and disclose PHI? ¨ protect patient rights? n n n Regularly review policies and procedures Update policies when new requirements emerge Monitor that policies/procedures are consistently applied throughout the organization

Privacy Rule: No Non. Health Usage of PHI The National Law Journal, May 30, 1994 A banker who also served on his county’s health board cross-referenced customer accounts with patient Information. He called due the mortgages of anyone suffering from cancer. Health information is not to be used for nonhealth purposes, unless an individual gives explicit permission

Privacy Rule: Need-to-Know Access Washington Post, March 1, 1995 The 13 -year-old daughter of a hospital employee took a list of patients’ names and phone numbers from the hospital when visiting her mother at work. As a joke, she contacted patients and told them they were diagnosed with HIV. CE/BA Employees should have access only to what is absolutely required as part of their jobs. n n What individuals should have access to PHI? What categories of PHI should individuals have access to? What conditions are required for access? How will Business Associates & Trading Partners be informed and controlled?

Privacy Rule: Protections against Marketing Boston Globe, August 1, 2000 A patient at Brigham and Women’s Hospital in Boston learned that employees had accessed her medical record more than 200 times. CE must obtain permission before sending any marketing materials, with limited exceptions

Privacy Rule: Establish Privacy Safeguards Required n Shut or locked doors n Keep voice down n Clear desk policy n Privacy curtains n Password protection n Auto screen savers n Locked cabinets n Paper shredders Not Required n Soundproof rooms n Redesign office space n Private hospital rooms (semiprivate ok) n OK for doctors to talk to nurses at nurse stations Safeguards should be REASONABLE

Privacy Rule: Employee Training & Accountability New York Times, Jan. 19, 2002 Eli Lilly and Co. inadvertently revealed over 600 patient e-mail addresses when it sent an all message to every individual registered to receive reminders about taking Prozac. n n Each CE organization shall name one person who is accountable for Privacy Rule compliance Each employee, volunteer, contractor shall be trained in privacy policies and procedures ¨ Full and Part-time

Privacy Rule: Individual Privacy Rights Patients have the Right to: n n n n See or obtain copies of medical information (except for psychotherapy notes) Request correction to health record Receive a Notice of Privacy Practices Request restrictions as to who can see PHI Request specific method of contact for sake of privacy Know who has accessed PHI File a complaint if their rights have been violated Allow and withdraw authorizations for use and disclosure CE must: n Respond to requests within 30 days n May extend delay with notice for another 30 days n Keep records of how PHI is disclosed

Notice of Privacy Practices Privacy n NPP must be available when asked for n NPP must be displayed prominently in the office n Health Plan must provide upon enrollment n Health Provider must provide on first service delivery n Both must request written acknowledgment of receipt of NPP n After change, revised NPP must be issued to clients within 60 days Electronic n Must be displayed prominently on web page n Must be emailed to customers after a change in NPP

Required & Permitted Disclosures Required Disclosure: n Patient ¨ n or personal representative, e. g. , parent, next of kin Office of Civil Rights Enforcement: Investigates potential violations to Privacy Rule Permitted Disclosure: n Minimum-Necessary PHI may be disclosed without authorization for: judicial proceedings, coroner/funeral, organ donation, approved research, military-related situations, government-provided benefits, worker’s compensation, domestic violence or abuse, some law enforcement activities n ID must be verified by proof of identity/badge and documentation

More Disclosures Routine Disclosure n Disclosures that happen periodically should be addressed in policies, procedures, forms n E. g. : Referral to another provider, school immunization, report communicable disease, medical transcription, births, deaths & other vital statistics Non-routine Disclosure n CEs shall have reasonable criteria to review requests for non-routine PHI disclosures n E. g. , Research disclosures Incidental Disclosure n CEs shall have reasonable safeguards n E. g. Patient overhears advice given to another patient Accidental Disclosure n Computer is stolen with PHI Disclosures must be tracked for THREE years

Disclosures Requiring Authorization n Research project (special conditions may allow) Person outside health care system Employer ¨ However, employer may require authorization for drug test before hiring Other insurance companies n Health care provider not involved in patient’s health care n Insurance company not paying patient’s claims n Lawyer Patient should get copy of authorization n

Sample Authorization Form Disclosure Authorization Form Description of Information: ___________________ Patient making authorized disclosure______________ Person receiving information: _________________ Purpose of the disclosure: Authorization Expiration Date: ________ Patient Signature_____________ Date: ______ A form to revoke authorization must be completed to terminate authorization. Must be retained by CE for 6 years

Implementing ‘Minimum Necessary’ Minimum necessary: Just enough info to accomplish the main purpose ¨ E. g. , Send prescription for glasses to optician, not medical history n Data Classification ¨ Sensitivity of information ¨ Type of treatment required n Questions to Answer ¨ What parts of record can each user type access? ¨ How will we constrain access to implement view?

Business Associates (BA) Not Business Associates Must also be responsible with PHI Accreditation nce g tin n u o Acc Legal Actuarial Consulting Adm inis Man tratio n& age men t ina F & Janitorial Electrical Phone Vending Copy Conduit: Mail Financial Institution: Banks

Business Associate Contract (BAC) CEs must request BA to sign a BAC: n BA will not disclose PHI n BA is liable for damage due to disclosure or misuse n BA will use safeguards to prevent misuse n BA will report any security incident or violation of agreement n BA will destroy or protect PHI upon termination of contract n CE can terminate contract if violation occurs n CE will provide BA copies of policies, procedures and materials for safeguarding n Etc. BAs are equally liable as CEs, under HITECH Act

HITECH: Health Information Technology for Economic and Clinical Health Act (2009) BA’s must follow the HIPAA Security Rule. n BA’s are held to the same standard as CE’s. n Health & Human Services (HHS) can: n ¨ require BA’s to comply with HIPAA. ¨ enforce penalties on noncompliant BA’s.

Violation of HIPAA Privacy Rule: WTHR Investigation Leads to Record $2. 25 M HIPAA Settlement, Indianapolis, IN, 2006: Reported that CVS was “throwing sensitive personal information in the trash” (e. g. : unredacted pill bottles, prescription instruction sheets, pharmacy receipts with credit card information and health insurance account numbers. After this, other CVS pharmacies were investigated and it was found that they also were improperly disposing of PHI. To see the above article, go to: http: //www. wthr. com/global/Category. asp? c=83157

The HIPAA Security Rule +

Security Rule Enforces Privacy Rule on Computers Privacy Rule With or w/o computer Protect PHI Security Rule With computer Protect EPHI Minimum Necessary Authentication & Access Control Accounting of Disclosures Unique Login Credentials Authentication Track modifications to EPHI: Who did what when?

Security Vocabulary Asset: Diamonds Threat: Theft Vulnerability: Open door or windows Threat agent: Burglar Owner: Those accountable or who value the asset Risk: Danger to assets

Security Rule Assures…

Security Services Authentication n Access Control n Data confidentiality n Data integrity n Data backup & recovery n Nonrepudiation = Cannot say it wasn’t you who sent or received data n Risk Management n

Risk Management Risk assessment n Policy & Procedures Maintenance n Security Program Enforcement n ¨ Audit logs, vulnerability assessments, audit for procedure adherence and control effectiveness ¨ Patches are applied to software ¨ Data is available, confidential, & integrity is protected

Security Rule Standards Comprehensive Technology Neutral Administrative Controls Security Rule Small or Large Physical Controls Technical Controls Scalable Look to Best Practices for Technology Answers e. g. NIST Security Rule

Three Areas of Safeguards Administrative: Administrative policies, procedures, and actions to implement and maintain security controls to protect EPHI, including risk mgmt, access control, contingency plans, incident response. Security Rule Physical: Protection of the physical access to terminals, laptops, servers, backup tapes, CDs, memory, including viewing, access, maintenance and disposal. Technical: Protection using technology tools to protect EPHI, including logs, encryption, authentication

Policies & Procedures Policies and Procedures MUST BE: n Retained for 6 years after date of creation or last effect n Available to workers responsible for them n Must be updated regularly accommodating changes in environment & operations

Security Rule Standard This is recommended… Address this in some way… Implement equivalent alternative measure…. If it doesn’t apply, document well why not… DO IT! We do this instead: …. .

Administrative: Security Mgmt Process Risk Analysis: Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the CIA of EPHI held by the CE. R Risk Mgmt: Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with the Security Rule R Sanction Policy: Apply appropriate penalties against workforce members who fail to comply with the entity’s security policies and procedures R Info System Activity Review: Implement procedures to regularly review records of IS activity, such as audit logs, access reports, and security incident tracking reports R

Security Mgmt Implications We will need an IT person to regularly check logs to be sure our system was not broken into The Sanction policy basically requires we all sign a confidentiality agreement and if someone breaks the rule, they could be fired. Risk assessment must be ‘accurate and thorough’ – that will be a challenge! And all are Rs… Security Mgmt Process

Administrative: Workforce Security Authorization and/or Supervision: Implement procedures for the authorization and/or supervision of workforce members who work with EPHI or in locations where it might be accessed Workforce Clearance Procedure: Implement procedures to determine that the access of a workforce member to EPHI is appropriate A A Termination Procedures: Implement procedures for A terminating access to EPHI when the employment of a workforce member ends…

Workforce Security Implications They are asking for checks and balances with supervision or authorization . We must have procedures to allocate authorization, periodically check authorization, and procedures to terminate someone Workforce Security We are a three person operation, can we get away with not doing this? Must we document our situation? These are As.

Administrative: Information Access Mgmt Isolating Health Care Clearinghouse (CH) Function: If a health care CH is part of a larger organization, the CH operation must implement policies and procedures that protect the EPHI of the CH from unauthorized access by the larger organization R Access Authorization: Implement policies and procedure for granting access to EPHI – e. g. , through access to a workstation, transaction, program, process, or other mechanism A Access Establishment & Modification: Implement policies and procedures that, based upon the entity’s access authorization policies, establish, document, review, and modify a user’s right of access to a workstation, transaction, program or process. A

Info Access Mgmt Implications Isn’t this the same as the previous rule? It is an implementation: We must define a data owner for each major process . And then our IT people must define how they will grant access based upon the data owner’s decisions. Info Access Mgmt

Administrative: Security Awareness & Training Security Reminders: Provide periodic security updates to members of the workforce A Protection from Malicious Software: Implement procedures for guarding against, detecting, and reporting malicious software A Login Monitoring: Implement procedures for A monitoring login attempts and reporting discrepancies Password Mgmt: Implement procedures for creating, changing and safeguarding passwords What do you think these mean? A

Administrative: Contingency Plan Data Backup Plan: Establish and implement procedures to create and maintain retrievable exact copies of EPHI R Disaster Recovery Plan: Establish … procedures to restore any loss of data R Emergency Mode Operation Plan: The emergency mode operation plan requires CEs to establish … procedures to enable continuation of critical business processes, while maintaining the security of EPHI while operating in emergency mode R Testing & Revision Procedure: Implement procedures for periodic testing and revision of contingency plans. A Applications & Data Criticality Analysis: Assess the relative criticality of specific applications and data in support of other contingency plan components. A

Administrative: One-Line Safeguards Assigned Security Responsibility: Identify the R security official who is responsible for the development and implementation of the policies and procedures required by this rule for the entity. Security Incident Procedures: Implement policies & R procedures to address security incidents. Identify and respond to suspected or known security incidents; mitigate … harmful effects of security incidents that are known to the CE; and document security incidents and their outcomes.

Administrative: More One-Line Safeguards Evaluation: Perform a periodic technical and nontechical evaluation, based initially upon the standards implemented under this rule and subsequently, in response to environmental or operations changes affecting the security of EPHI, that establishes the extent to which an entity’s security policies and procedures meet the requirements of this subpart R BA Contracts and Other Arrangements: A BA [may] create, receive, maintain, or transmit EPHI on the CE’s behalf only if the CE obtains satisfactory assurances that the BA will appropriately safeguard the information. R

Info Access Mgmt Implications According to Evaluation, we must self-test or be certified on a regular basis, to be sure we follow the Security Rule That makes sense when technology changes, but I guess we have to do it periodically as well, since the world changes. We need to know who, what, when, where, why for incident response. Evaluation Who shall we name as our Security Manager?

Physical Safeguards: Facility Access Controls: Implement policies and procedures to limit physical access to electronic info systems and areas where sensitive paper documents are stored any facilities in which they are housed, while ensuring authorized access Contingency Operations Facility Security Plan Access Control & Validation Procedures Maintenance Records A A

Physical Safeguards: Facility Access Control n n n How will physical access be restricted to sensitive paper documents, terminals, server, backup copies, laptops, contingency operations in copy, view, or modify forms? How are visitors controlled from accessing PHI/EPHI? When repairs occur (to facility or systems) how will PHI/EPHI be safeguarded?

Physical Safeguards: Workstations Workstation Use: Implement policies and R procedures that specify the proper functions to be performed, the manner in which those functions are to be performed, and the physical attributes of the surroundings of a specific workstation or class of workstation that can be used to access EPHI Workstation Security: Implement physical R safeguards for all workstations that can be used to access EPHI, to restrict access to authorized users

Workstation Use and Security n n n What functions will be performed on which workstations? How will workstation access be limited when the user leaves their station? How will theft of laptops be prevented? How will the workstations be positioned? What other physical safeguards (locked rooms, hoods) will be implemented to prevent shoulder surfing?

Physical Safeguards: Device & Media Controls Device and Media Controls: Implement policies and procedures that govern the receipt and removal of hardware and electronic media and devices that contain EPHI into and out of a worksite or facility, and the movement of these items within the worksite or facility. Disposal Media Reuse Accountability Data Backup and Storage R R A A

Device & Media Controls n How will media be erased or damaged before disposal or reuse? ¨ Reformatting disk may not be adequate even for reuse n n How, when and where has EPHI been moved or transferred? Documentation is necessary How is a backup made and where/how stored?

Technical Safeguards: Access Control: Implement technical policies and procedures for electronic info systems that maintain EPHI. These policies and procedures should contain access protocols that will establish and enforce the entity’s other access policies, and allow access only to those persons or software programs that have been granted access rights Unique User Identification Emergency Access Procedure Automatic Logoff Encryption and Decryption R R A A

Technical Safeguards: Access Control n n n How is each user uniquely identified to the system? How does authentication occur? In an emergency, what backup methods are used for authentication? How does automatic logoff occur after a period of inactivity? Which data is encrypted in storage and/or transmission?

Technical Safeguards: Transmission Security: Implement technical security measures to guard against unauthorized access to EPHI that is being transmitted over an electronic communications network Integrity Controls A Encryption A

Technical Safeguards: Transmission Security How are we sure that data is not modified or lost during transmission? n What encryption techniques are used to protect the security of EPHI transmitted over a public network? n

Other Technical Safeguards Audit Controls: Implement hardware, software, and/or R procedural mechanisms that record and examine activity in information systems that contain or use EPHI Integrity: Implement policies and procedures to protect EPHI at rest, meaning stored on organizational systems and applications, from improper alteration or destruction. Person or Entity Authentication: Implement procedures to verify that a person or entity seeking access to EPHI is the one claimed A R

Other Technical Safeguards n n n For which devices will the logs be monitored? What log events should be archived for security purposes? How will potential attacks found in logs be recorded, reported, and acted upon? What techniques will be used to ensure stored data has not been modified (hashes, message digests? ) What authentication mechanisms will be used to assure that approved entities (people or systems) are accessing EPHI?

Question An example of a vulnerability is 1. Theft 2. Burglar 3. Open door 4. Diamonds

Question 1. 2. 3. 4. Protected Health Information is: SSN, medical information Name, address, SSN, phone, medical information Medical information stored in a computer

Question The Security Rule requires that: 1. Logs are monitored 2. An intrusion detection system is implemented 3. Cabinets containing PHI must be locked 4. Walls must be soundproof and all terminals outside of waiting room

Question The Privacy Rule requires that: 1. Logs are monitored 2. An intrusion detection system is implemented 3. Cabinets containing PHI must be locked 4. Walls must be soundproof and all terminals outside of the waiting room

Question The Addressable option for the Security Rule means: 1. Smaller organizations need not implement if they can justify it would be too expensive 2. HIPAA discusses alternative means to accomplish this, and the organization must select one 3. The CE must document how they accomplish this provision 4. This provision must be implemented or addressed in some way, although alternative implementations are allowed

To Study: n n n Define HIPAA, Privacy Rule, Security Rule, CE, PHI. Define threat, vulnerability, threat agent Describe what Privacy Rule covers at a high level Describe what Security Rule covers at a high level Describe the difference between Required and Addressable for the Security Rule.

Not Covered in this Presentation Some specialized material is not being covered as part of this presentation, including: n Hybrid Entities: Part Covered, Part Not n Organized Health Care Arrangement (OHCA): Group of doctors n Jointly Administered Govt. Program n Trading Partner: CEs exchange electronic transactions without clearinghouse

COBRA n The Consolidated Omnibus Budget Reconciliation Act of 1986. This allows some types of employees (and their families) to continue health coverage when they change/lose a job for a maximum of 18 mos.