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HIPAA HITECH Briefing IRB Monthly Investigator Meeting Karen Pagliaro-Meyer Privacy Officer Columbia University Medical Center

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Presentation on theme: "HIPAA HITECH Briefing IRB Monthly Investigator Meeting Karen Pagliaro-Meyer Privacy Officer Columbia University Medical Center"— Presentation transcript:

1 HIPAA HITECH Briefing IRB Monthly Investigator Meeting Karen Pagliaro-Meyer Privacy Officer Columbia University Medical Center June 2010 1

2 Administrative Simplification [Accountability] Insurance Reform [ Portability] Health Insurance Portability and Accountability Act (HIPAA) Transactions, Code Sets, & Identifiers Compliance Date: 10/16/2002 and 10/16/03 Transactions, Code Sets, & Identifiers Compliance Date: 10/16/2002 and 10/16/03 Privacy Compliance Date: 4/14/2003 Privacy Compliance Date: 4/14/2003 Security Compliance Date: 4/20/2005 Security Compliance Date: 4/20/2005 Fraud and Abuse (Accountability) HITECH Health Information Technology for Economic and Clinical Health 9/18/2009

3 HITECH (ARRA) Health Information Technology for Economic & Clinical Health REQUIREMENT COMPLIANCE DATE 1.Breach NotificationSeptember 2009 2.Self-Payment DisclosuresFebruary 2010 3.Business AssociatesFebruary 2010 4.Minimum NecessaryAugust 2010 5.Accounting of DisclosuresJanuary 2011/2014 6.Performance Measures for EHR – enhanced reimbursement rate 3

4 HITECH Act (ARRA) Health Information Technology for Economic and Clinical Health 4  New Federal Breach Notification Law – Effective Sept 2009  Applies to all electronic “unsecured PHI”  Requires immediate notification to the Federal Government if more than 500 individuals effected  Annual notification if less that 500 individuals effected  Requires notification to a major media outlet  Breach will be listed on a public website  Requires individual notification to patients  Criminal penalties - apply to individual or employee of a covered entity

5 5  Enforcement  Increased penalties for HIPAA Violations (tiered civil monetary penalties)  Required Audits and Investigations  Increased enforcement and oversight activities  State Attorneys General will have enforcement authority and may sue for damages and injunctive relief.  Tiered Civil Penalties  When the person did not know about the violation $100 per violation (max $25,000) to $50,000 (max $1.5 mil)  Where the violation was due to reasonable cause and not to willful neglect $1,000 per violation (max $100,000) to $50,000 (max $1.5 mil)  Where the violation was due to willful neglect $10,000 per violation (max $250,000) and $50,000 (max $1.5 mil) HITECH Act (ARRA)

6 6 Laptops. Of the 95 breaches on the Office for Civil Rights (OCR) website as of June 17, 32, or 34%, involved laptop computers. Another 11 incidents involved the loss or theft of portable devices. HITECH mandates that OCR to post the breaches on its website. In its first public posting in February, OCR listed 32 entities that reported the egregious

7 7  Self Payment Disclosures  If patient pays for service – has the right to limit the disclosure of that information  Business Associates  Standards apply directly to Business Associates  Statutory obligation to comply with restrictions on use and disclosure of PHI  New HITECH Privacy provisions must be incorporated into BAA  Minimum Necessary Standards  New Definition of Minimum Necessary, determined by the disclosing party, encourage the use of limited data sets HITECH Act (ARRA)

8 HITECH ACT (ARRA)  Accounting of Disclosures  Right to request copy of record in any format and to know who viewed, accessed, used or disclosed their medical information  Electronic Health Record  Performance Measures for EHR enhanced reimbursement  Patient has a right to electronic copy of records  Electronic copy transmission  Delivery options  96 hours to make information available to the patient  Meet Meaningful Use Standards 8

9 Who is a Business Associate? Individuals who do business with CUMC and have access to protected health information. Signed Business Associate Agreement (BAA) is needed to assure that they will protect the information and inform CUMC if the data is lost or stolen. Examples of BAAs include:  billing companies or claims processing  voice mail or appointment reminder service management  transcription services or coding companies  accreditation  consultants  Software used for medical data 9

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13 New York State SSN/PII Laws Information Security Breach and Notification Act  Effective December 2005  IF… Breach of Personally Identifiable Information occurs o SSN o Credit Card o Driver’s License  THEN… Must notify o patients / customers / employees o NY State Attorney General o Consumer reporting agencies o RED FLAG REGULATIONS o New enforcement date June 1, 2010 o Medical Identity Theft accounted for 7% of all ID Theft – up from 3% - new threat 13

14 T ypes of confidential electronic information: ePHI = Electronic Protected Health Information – Medical record number, account number or SSN – Patient demographic data, e.g., address, date of birth, date of death, sex, e-mail / web address – Dates of service, e.g., date of admission, discharge – Medical records, reports, test results, appointment dates PII = Personally Identified Information – Individual’s name + SSN number or Driver’s License # or credit card # Electronic media = computers, laptops, disks, memory sticks, PDAs, servers, networks, dial-modems, cell phones, email, web-sites, etc. 14

15 Types of Security Failures  Failing to encrypt protected health information (PHI)  Sending EPHI outside the institution without encryption – Under HITECH you may be personally liable for losing EPHI data  Losing Laptop or other portable device in transit with unencrypted PHI or PII – Under HITECH and NY State SSN Laws, you may be personally liable, and you will be disciplined for loss of PHI or PII  Failing to follow basic Security Requirements – Sharing passwords, signing on to applications for another user, failing to sign off a workstation 15

16 Types of Security Failure  Social Security Numbers  First avoid SSN (and Driver’s License, Credit Card Numbers) REFUSE to take files or reports with SSN if not needed  Do not store SSN long-term DESTROY the file/report as soon as you are done with it. Delete the file from your computer, delete the email that brought the file, etc. Or, using an editor program, cut out SSN from the file.  Do not keep the complete SSN ERASE first 5 digits of SSN.  Encrypt SSN, and Obfuscate SSN If you must keep it, keep SSN in an encrypted file or folder.  Do not show the SSN in an application, or show only the last 4 digits if that meets the needs. AUTHENTICATE again if complete SSN is shown, and LOG who saw the SSN. Ask why SSN needed. 16

17 Good Computing Practices: 10 Safeguards for Users 1. User Access Controls (Sign on, restricted access) 2. Passwords 3. Workstation Security 4. Portable Device Security – USB, Laptops 5. Data Management, e.g., back-up, archive, restore 6. Remote Access - VPN 7. Recycling Electronic Media & Computers 8. E-Mail – Columbia/NYP email account ONLY 9. Safe Internet Use 10. Reporting Security Incidents / Breach

18 Safeguard #1 Unique User Log-In / User Access Controls Access Controls: – Users are assigned a unique “User ID” for log-in purposes – Each individual user’s access to ePHI system(s) is appropriate and authorized – Access is “role-based”, e.g., access is limited to the minimum information needed to do your job – User access to information systems is logged and audited for inappropriate access or use – Unauthorized access to ePHI by former employees is prevented by terminating access 18

19 Safeguard #2 Password Protection To safeguard YOUR computing accounts, YOU need to take steps to protect your password Don't share your password — protect it the same as you would the key to your home. After all, it is a "key" to your identity. Do not write down your user ID /password and leave unsecured Don't use a word that can easily be found in a dictionary — English or otherwise. Use at least eight characters (letters, numbers, symbols). Don't let your Web browser remember your passwords. Public or shared computers allow others access to your password. 19

20 Safeguard #3 Workstation Security “Workstations” include any electronic computing device, for example, a laptop or desktop computer, or any other device that performs similar functions, and electronic media stored in its immediate environment. Log-off before leaving a workstation unattended. – This will prevent other individuals from accessing EPHI under your User-ID and limit access by unauthorized users. Lock-up! – Offices, windows, workstations, sensitive papers and PDAs, laptops, mobile devices / media. – Lock your workstation (Cntrl+Alt+Del and Lock) – Windows XP, Windows 2000 – Do not leave sensitive information on remote printers or copier. 20

21 Safeguard #4 Security for USB drives & Storage Devices USB drives are new devices which pack a lot of data in tiny packages. e.g., 256MB, 512MB, 1GB. Approved encrypted devices include: Lexar or Kingston Data Traveler Safeguards: – Don’t store ePHI on USB drives – If you do store it, either de- identify it or use encryption software – Delete the ePHI when no longer needed 21 Delete temporary ePHI files from local drives & portable media too!Delete temporary ePHI files from local drives & portable media too!


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24 Safeguard #6 Secure Remote Access Standards for remote network access by laptops, home computers and PDAs (same standard as desktops at work): Minimum network security standards are: 1.Software security patch up-to-date 2.Anti-virus software running and up-to-date on every device 3.Turn-off unnecessary services & programs 4.Physical security safeguards to prevent unauthorized access Consider these also: 5.Host-based firewall software – running & configured 6.Placement to conceal screen content 7.No downloads from lesser known web sites 8.No peer-to-peer software, use only work related software 24 Apply these same standards to all portable devices & home PCs.

25 Safeguard # 7 Data Disposal: Clean devices before recycling Destroy ePHI data which is no longer needed: – “Clean” hard-drives, CDs, zip disks, or back-up tapes before recycling or re-using electronic media. – Have an IT professional overwrite or destroy your digital media before discarding – via magnets or special software tools; and/or – Know where to take these items for appropriate safe disposal – Do not just donate an old workstation without cleaning the disks 25

26 Safeguard #8 E-Mail Security E-mail is like a “postcard”. E-mail may potentially be viewed in transit by many individuals, since it may pass through several switches enroute to its final destination or never arrive at all! E-mails containing ePHI needs a higher level of security 1. Do not use personal e-mail accounts to communicate any information related to CUMC. 2. Do not send or forward emails with ePHI from secure addresses to non-institutional accounts, e.g., Hot Mail, Google, Yahoo, etc. 3. Use secure, encrypted email software, if available (e.g. WINZIP) 4. Security at the Subject Line: Avoid using individual names, medical record numbers or account numbers in unencrypted e-mails 26

27 Safeguard #10 Report Information Security Incidents You are responsible to:  Report and respond to security incidents and security breaches.  Know what to do in the event of a security breach or incident related to ePHI and/or Personal Information.  Report security incidents & breaches to: Help Desk 305-HELP (ext. 54357) 27

28 Sanctions for Violators Workforce members who violate policies regarding privacy / security of confidential /protected health information or ePHI are subject to corrective & disciplinary action. Actions taken may include: – Department/Grant responsible for fines, penalties, notification costs etc. – Counseling & additional training – Suspension – Termination of access to applications – Violation of City, State and Federal laws may carry additional consequences of prosecution under the law – Knowing, malicious intent can = Penalties, fines, jail! 28


30 Information Security Reminders Password protect computer/data Run Anti-virus & Anti-spam software, Anti-spyware Keep office secured ENCRYPT! Use institutional E-mail Use Encryption for Portable Devices with PHI

31 HIPAA and Research HIPAA Research Use & Disclosures Authorization signed by patient for all clinical research Form A Waiver Criteria applied before records research Form B Exceptions Documented Preparatory to research Research on decedents Form D & E Limited data-set Form F De- identified Form G Form C Recruitment Waiver

32 HIPAA Form A Authorization signed by patient for all clinical research TWO signatures required 1.Consent to participate in research 2.Authorization to USE information collected If Consent is being obtain then HIPAA Authorization must also be obtained Information Sheet – must include HIPAA language Single signature - Combined consent and HIPAA authorization International Research 32

33 HIPAA Form B Waiver Criteria applied before records research Mostly retrospective medical record reviews All 5 questions must be answered and must explain why subject consent/authorization is not practical. Partial waiver of signed authorization is required when information sheet will be used Can not waive authorization for records that do not belong to CUMC/NYP 33

34 HIPAA Form D & E Exceptions Documented Prepatory to Research & Decedent Data Research Form D should be attached when investigator will review multiple records, schedules, or other items to identify potential candidates or if involved in preliminary research to establish a thesis Form E - Research on decedents – Really only needed when research will focus exclusively on decedents. 34

35 HIPAA Form F Limited Data-set SIGNED agreement when research will include DOB, Date of admission, surgery, event, MRN Multi Center studies – whose Data Use Agreement HIPAA form F is written to reflect that CUMC is the data owner. Data sharing should not be initiated until document is fully executed A lab not involved in research performing a paid function is a Business Associate not a research collaborator. 35

36 Form G De-identified Data Assumes NONE of the 18 identifiers will be COLLECTED during research Name, address, email, telephone, photo, ss#, DOB, credit card number A code or link back to source data is not permitted International research may qualify for de- identified data if the code/link to identifiers is not brought back to CUMC / USA 36


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