Presentation on theme: "HIPAA/ HITECH: Relief for the Newest Regulatory Headache"— Presentation transcript:
1HIPAA/ HITECH: Relief for the Newest Regulatory Headache Kippy L. Wroten Founding Shareholder, Wroten & AssociatesDarryl A. Ross Shareholder, Wroten & Associates
2Scope of the Omnibus Rule Research uses of data – compound, more general authorizations.Patients’ right to restrict data sharing with payors.Requirements to modify and redistribute notices of privacy practices.Inclusion of limitations on use of genetic information for underwriting.Clarifies HHS Secretary’s role in enforcement, imposition of civil money penalties (CMPs) and CMP liability for acts of agents.
3What’s Not in the Omnibus Rule Accounting of Disclosures – still in process.Methodology for giving individuals “harmed” by HIPAA violations a percentage of any civil monetary penalties or settlements collected.Guidance for implementation of minimum necessary standard.HITECH also mandated study of definition of “psychotherapy notes” – no specific deadline for the study.
4HIPAA - Privacy vs. Security HIPAA Privacy RuleThe need to protect medical records and other health information in any form (electronic, paper, or out of our mouths) from being shared, viewed, distributed, etc.HIPAA Security RuleThe need to develop and maintain security of all electronic health information, including storage and transmission.The purpose of the HIPAA privacy rule is to protect health information from disclosure and the purpose of the HIPAA security rule is maintain secure storage and transmission. The HITECH Act adds the strength of enforcement for security breaches.44
7Health Information Technology for Economic and Clinical Health Act (2009) Expands Protection
8How Do HIPAA & HITECH Apply to Me? Covered EntitiesHybrid EntitiesBusiness Associates (Vendors)
9Protected Health Information What is it?Identifies the individualTransmitted or maintained by a CE or BARelates to individual's physical or mental health or payment for health careDemographic information
10PHIDid You Know?Vehicle ID & Serial Numbers - license plate numbersDevice ID & serial numbersUniversal Resource Locators (URLs)Internet Protocol (IP) addressesBiometric identifiers, including finger and voice printsFull face photographic images and any comparable imagesAny other unique identifying number, characteristic, or codeCommonNamesSSNMedical record #sAccount numbersDates of treatmentProbably AwareTelephone numbersFax numbersElectronic mail addressesCertificate/license numbers
12Covered Entities Health Plans An individual or group plan that provides or pays the cost of medical careHealth care clearinghousesA public or private entity, including a billing service, re-pricing company, community health management information system or community health information system, and “value added” networks and switches that either process or facilitate the processing of health informationHealth care providersCare, services, or supplies related to the health of an individual, including (1) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual that affects the structure or function of the body; and (2) sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.+ …who electronically transmit any health information
13Hybrid EntitiesA single legal entity that is a covered entity, performs business activities that include both covered and non-covered functions, and designates its health care components as provided in the Privacy Rule. If a covered entity is a hybrid entity, the Privacy Rule generally applies only to its designated health care components. However, non-health care components of a hybrid entity may be affected because the health care component is limited in how it can share PHI with the non-health care component. The covered entity also retains certain oversight, compliance, and enforcement responsibilities.
14Who is a Business Associate? Claims ProcessingData AnalysisUtilization ReviewBillingLegal (including litigation counsel)ActuarialAccountingConsultingData AggregationManagementAdministrativeAccreditationFinancial ServicesE-Discovery VendorsCopier Technicians (if your copier has memory)Shredding ServicesComputer Support ServicesRecords subpoenas/duplication services
15Business Associates HITECH Expands Privacy and Security Expanded definition of "business associate“ - “Business associate” means one who, on behalf of a Covered Entitycreates, receives, maintains or transmits PHI"Business associate" now also means "subcontractor of business associate“ who creates, receives, maintains or transmits PHI on behalf of a business associateStatus as Business Associate based upon role and responsibilities, not upon who are the parties to the contract
16Business Associate Definition Clarifications Rule clarifies definition of "business associate” -- included:Patient Safety OrganizationsHealth information exchange organizations, e-prescribing gateways, covered entities' personal health record vendors (not all PHRs)Data transmission providers that require access to PHI on a routine basisNot included – those who just provide transmission services, like digital couriers or “mere conduits.”However, those who store PHI, even if they don’t intend to actually view it, are BAs (implications for cloud model EHRs).
18Do They Know Who They Are? Implications for subcontractor relationshipsContract between the covered entity's BA and that BA'sSubcontractor must satisfy the BAA requirementsSubcontractor of subcontractor is also a BA, and so onAs a result, HIPAA/HITECH obligations that apply to BAs also directly apply to subcontractors
19BAs – Uses of PHI Uses of PHI – Must pass along in subcontracts BAs may use or disclose PHI only as permitted by BAA or required by lawBAs may not use or disclose PHI in manner that would violate Privacy RuleSubcontractors subject to limits in initial CE-BA agreement– Must pass along in subcontractsBAs not making a permitted use or disclosure if notFollow minimum necessary rulesBA does not comply if it knows of subcontractor's material noncompliance and does not take reasonable steps to cure the breach or, if such steps fail, to terminate the relationshipBAs (incl. subcontractors) subject to civil money penalties for HIPAA violationsBA/subs remain liable under contract to CE/BASecretary authorized to receive and investigate complaints against BAs (including subcontractors), and to take action regarding complaints and noncomplianceBAs (incl. subs) required to maintain records and submit compliance reports to Secretary, cooperate in complaint investigations and compliance reviews, give Secretary access to informationBAA - Generally, compliance required 180 days following Omnibus Rule’s effective date (3/26/13), which is 9/23/13
20Omnibus Rules Compliance Omnibus Rules Compliance Date: September 23, 2013
21Compliance Plan - Step One Have you established an executive/board-level responsibility for HIPAA compliance?Have you designated yourself as a (a hybrid entity, or (b) a single affiliated covered entity with other legally separate covered entities under common ownership or control?Have you taken the necessary follow-up steps to document?Have you designated responsible persons for Privacy? For Security? Do you have job descriptions?Have you distributed a Notice of Privacy Practices with the identification of the Privacy and Security Officers?Have you posted information and trained staff?Has the staff signed confidentiality agreements related to privacy and security?Do you have Business Associate Agreements in place?Cover new rules re governing body responsibilityFacility level Privacy & Security OfficersRequired NPP re-distributionHealthIT.govBAAs
22Compliance Plan - Step Two Is HIPAA privacy and security included in new employee orientation?Is your Governing Body/Board trained?Are volunteers and clergy trained?How do you facilitate privacy and security awareness?Includes reporting concerns: hot lines, confidential reportingNo retaliation! Remember whistle blowers are waiting to report you.Self reporting – do it often.
25Security Risk Assessment- Organizational Requirements Business Associates IdentifiedPolicies & Procedures adoptedDocumentation procedures adoptedRefer to dt # for assessment outline
26Security Risk Assessment Security Awareness and TrainingSecurity Incident ProceduresWorkstation UseDevice and Media ControlsAccess ControlIntegrityPerson/Entity AuthenticationTransmission SecurityCt # (62 pages) for regulatory crosswalk
27Access ControlsLimit physical access to its electronic information systems, including facilities where data housed. § (a)(1).Workstation Security - physical safeguards for all workstations that access ePHI. § (c).Must assure authorized users have access.
28Workstation Security Compliance Practices Identify desktop/laptops containing ePHILock down procedures.Policies to prevent unencrypted ePHI from being stored on portable electronic devices and laptops.Encryption practices.
29Device Controls and Re-Use § (d)(2)(ii) - Re-Use§ (d)(1) - ControlsP&Ps governing removal of ePHI before device re-used.P&Ps to assure ePHI is unusable and/or inaccessible prior to re-using device.All storage devices or all ePHI records must be overwritten multiple times, in accordance with NIST guidelines.Movement within facility.Removal of hardware from facility.P&Ps to address final disposition of ePHI and/or medium where storedNational Institute of Standards and Testing29
30Disposal Compliance Practices ePHI on must be rendered unusable and/or inaccessible prior to disposal.When portable media is discarded, it should either be overwritten multiple times, in accordance with NIST guidelines.Maintain a record of where the hardware is, and the person responsible for it. § (d)(2)(iii).hardware and electronic media, including copiers, faxes, printers, etc., isApplies to business associates30
31Accountability Practices for Compliance Identify types of hardware and electronic media that must be tracked.Create record / log to track where devices are.Portable devices should not ordinarily contain ePHI and must be individually identified in the tracking system in order to contain ePHI.Possession of portable device with ePHI must be consistent with the individual’s position.Inventory should be physically confirmed at least annually.
32Data Backup and Storage Create a retrievable, exact copy of electronic protected health information, when needed, before movement of equipment. § (d)(2)(iv)Establish a process for documenting or verifying its creation.
334 Components of Compliant Technical P&P’s § (a)(2)(i) Unique name / identifier to track users.§ (a)(2)(iii) Automatic logoff procedures§ (a)(2)(iv) Encryption and decryption procedures§ (a)(2)(ii) Emergency access procedures.§ mandates that a covered entity "implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs that have been granted access rights3333
34Step 1: User IDUnique account for each user including unique username and password if access to ePHI.Verification proceduresP&Ps to map permissionsGeneric or shared accounts are not permitted for access to ePHI.Verification procedures to assure individual or entity who is authorized to access ePHI and that the identity is correctly bound to a unique user identification (“sign-on”) for access to ePHI.34
35Step 2: Emergency Controls Protocol should be writtenDo not rely on availability of a single individual.Identify roles that may require special access during an emergency.Proper ID of individuals required Access to power or a network?If electronic systems are a copy of the medical record and access to the system is not necessary for safe patient care, use of medical records while the systems is unavailable is acceptableDo You Know What You Will Do If The Lights Go Out?
36Step 3: Auto Logoff Compliance Practices Best practice: require electronic to be terminated.If terminating session isn’t possible, implement automatic workstation lockout as a compensating control.What’s an appropriate amount of inactivity before automatic lockout?10 MINUTES
37Step 4: Encryption Technical Standards HITECH references NIST encryption standardsEnforce complex passwords where possibleProtection from malicious software for details)Ensure secure remote accessImplement correctly configured firewalls (hardware and/or software), specifically the Federal Information Processing Standard FIPS identifies requirements for specific encryption algorithms and modules that are tested and approved to protect information ranging in various levels of sensitivity. Healthcare organizations should look for IT products that state conformance with FIPS3737
38Step 4: Encryption – Decryption: P&Ps Unique user ID’sFrequent changes to ID’sProhibit unencrypted ePHI will not be stored on portable electronic devices, including laptops.Remote wipe proceduresIncorrect PasswordIT Personnel, specifically the Federal Information Processing Standard FIPS identifies requirements for specific encryption algorithms and modules that are tested and approved to protect information ranging in various levels of sensitivity. Healthcare organizations should look for IT products that state conformance with FIPS3838
39Common Sense & Security Log off your system if you are not in front of it.Remove patient/resident/employee data from view.Make sure others cannot see your computer screen.Don’t place patient/resident/employee data on a flash drive, CD, diskette, or even your C: drive if you have PC.Don’t give anyone your passwordAny device /laptop used to store/transmit PHI must be encrypted – don’t store/transmit PHI on personal devices.“Secure” all PHI when sent outside of secure environmentsTextsEmphasize the use of common sense in securing PHI. Any company hard drive should be encrypted, and all PHI transmitted from the server to a third party must be “Secure”. Contact the IT security mailbox for help with the request.3939
40Mobile Devices & Security Enterprise issued mobile devicesPassword protectedEncryptedRemote monitoringRemote wiping (destruction)BYODAre they secure?Dealing with physicians who insist on textingDifference between sending and receivingEducation & Training - materialshealthit.gov/providers-professionals/downloadable-materials
41Risks Mobile Devices Mobile devices produced for consumer use. Can store massive amounts of data.Lack security and operational controls to enable management of the device from a centralized system.Easily lost or stolen and pose increased risks to the confidentiality and security of patient health information.Loss or theft may result in breach notification.As a result, incidents can arise from not being able to adequately detect, manage, or provision and de-provision the device.41
43ANDTHISORTHISWHAT IS THIS?SAY HELLO TO YOUR DATA
44ePHI & Text Messaging – P&Ps Appropriate use of work-related texting.Prohibiting texting of ePHIRequiring medical records be updated if ePHI received via text.Identifying retention period for any ePHI received via text.An inventory of all mobile devices used for texting ePHI (whether provider-owned or personal devices).Complicated by litigation holds.44
45Device Ownership. BYOD Considerations Written authorization before storing ePHI.A clear definition of data ownership.Define what is acceptable use.Annual acknowledgment of organization P&PsReservation of rights to examine devicesProcedures during employee or contractor separationDefine data belong to the organization and data that may belong to the individual user.Make clear that in the event of potential breach or employee separation, organization will act to protect its interests.
46BYOD Policies To Consider Appropriate use of textingAppropriate use of camera and videoAppropriate use of sensitive informationRequirements for password protection and lock-out features.Prohibition on altering factory defaults and operating systems (i.e., jail-breaking)Appropriate use of applications and conditions of downloading software.Define data belong to the organization and data that may belong to the individual user.Make clear that in the event of potential breach or employee separation, organization will act to protect its interests.
47Technology Solutions for Mobile Devices Password protection and encryption for mobile devices that create, receive or maintain text messages with ePHI.Enterprise control to oversee communication useEnterprise control to wipe information from lost devices and/or separated employeesUse of a secure messaging application.Audit trail system.
49Event Management: Breach Ready or not, expect there will be a breach
50Risk Assessment: Breach CE/BA should perform risk assessment post-breach discovery and must consider at least the following:Nature and extent of PHI involved, including types ofIdentifiers and likelihood of re-identificationWho was the recipient of the PHIWas the PHI actually acquired or viewedThe extent to which the risk to misuse of the PHI has beenMitigated
51Risk Analysis Criteria Likelihood of identification or re-identification:a list of patient names – not low probabilitypatient discharge data, patient not specified – can patients be re-identified? – could be low probability (depends on the circumstances)Who is the unauthorized recipient:a HIPAA covered entity – low probability, as long as you have evidence the risk has been mitigatedan employer – may be able to use personnel records to re-identify – not low probabilityPHI actually acquired or viewed:untampered with laptop – low probabilityinformation mailed to wrong person – not low probabilityHas improper use been mitigated:satisfactory assurances of destruction from a known person – low probability
52Risk of Harm Analysis To whom was the PHI disclosed? RISK EVALUATION Did the breach pose a significant risk of financial, reputational, or other harm to the individual?To whom was the PHI disclosed? RISK EVALUATIONAnother employee/BA? Low riskWrong fax number/unauthorized family member? Moderate riskPHI lost or stolen? High riskIn what form was the PHI accessed, used, or disclosed?Verbal? Low riskPaper? Moderate riskElectronic? High riskWhat event caused the access, use, or disclosure of PHI?Unintentional disclosure? Low riskIntentional disclosure? Moderate riskHacking/theft? High riskWhat type of PHI was impermissibly accessed, used, or disclosed?Limited data set? Low riskNon-sensitive PHI? Moderate riskTreatment provided? Potentially higher riskSubstance abuse, mental health, contagious disease? High riskSSN’s, Tax ID, Account #s, Passwords / Digital Signatures Very high riskWhat steps were taken to mitigate potential harm related tothe impermissible access, use, or disclosure?PHI returned before accessed? Low riskPHI properly destroyed? Low riskRecipient signed a confidentiality agreement? Low riskImmediate steps taken to reduce risk of harm? Low – moderate risk
53Definition of “Breach” Definition changed from the interim rule definitionAn impermissible use or disclosure of PHI is presumed to be a breach unless the covered entity or business associate demonstrates there is low probability that the PHI has been “compromised”
54Has A Breach Occurred? Is the information unsecured PHI? Was the PHI de-identified?Was the PHI acquired, accessed, used, or disclosed in accordance with the Privacy Rule?Was the PHI encrypted?Was the PHI properly destroyed?If any of the above answers is "yes", then the information is not unsecured PHI therefore no breach has occurred and notification is not required.
55Privacy & Security Exceptions Did a CE/BA workforce member unintentionally access or use the PHI while acting within the scope of their duties?Was the impermissible use and/or disclosure stopped before further disclosure occurred?Did a CE/BA workforce member inadvertently disclose PHI to another workforce member where all were otherwise authorized to access/use PHI?Was the use/disclosure of PHI incident to an otherwise permissible use or disclosure where the minimum necessary requirement was followed?Was the PHI impermissibly disclosed to an unauthorized person but there is a good faith belief exists that the recipient would not be able to retain the PHI?If any of the above answers is "yes", then no breach has occurred and notification is not required.
56Breach Decision Tree No No No Yes No Yes No No Notification under HITECH: Determine if state breach notification laws applyIs the information PHI?NoYesNo Notification under HITECH: Determine if accounting and mitigation obligations under HIPAAIs the PHI unsecured?NoYesIs there an impermissible acquisition, access, use or disclosure of PHI?No Notification under HITECHNoYesDoes the impermissible acquisition, access, use or disclosure compromise the security or privacy of PHI? Has a written risk assessment been completed?No Notification under HITECH: Determine if accounting and mitigation obligations under HIPAANoYesDoes an exemption apply?NoNotification Required; Determine methods for notification for affected individuals, the Secretary of HHS and, if necessary, media
58Breach Notification Notification of Breach Data breach notification requirements imposed for unauthorized uses and disclosures of "unsecured PHI."Patients must be notified of any unsecured breach.If a breach impacts 500 patients or more, HHS must also be notified, and breaching entity's name will be published on HHS' website.Under certain conditions local media will also need to be notified.Notification is triggered whether the unsecured breach occurred externally or internally.The HITECH Act requires notification of security breaches and establishes enforcement mechanisms (and the potential for staggering fines) for security breaches of electronic PHI.5858
59Notice of Privacy Practices Redistribution required!
60Notice of Privacy Practices (NPP) NPPs must include:Statements regarding certain uses and disclosures requiring authorizationPsychotherapy notes (where appropriate);Marketing;Sales of PHI;Right to restrict disclosures to health plans (provider only); andRight to be notified of breach.General statement that all uses and disclosures not described in NPP also require authorization
61Notice of Privacy Practices Does it contain all the required elements?“This notice describes how medical information about you may be used and disclosed and how you can get access to this information please review it”.Include examples of types of use and disclosures.List of uses and disclosures allowed without authorization.List of individual’s rights.Privacy Officer contact information.Do you use PHI for marketing?Do you use PHI for research?
62Covered Entity - Privacy Obligations Is NPP posted?Has NPP been translated?What is your process for delivery?What is your process to re-distribute when there are changesIs your NPP posted on websites?
63Omnibus Rule – NPPs must be Revised Changes in rule are materialFor plans that post on website, post revised NPP by effective date and in next annual mailingIf no web site, plans must provide within 60 days of material revisionFor providers, must post and make available upon request; must provide to (and seek acknowledgement from) new patientsCan send by if individual agrees
64Important Next Steps Review policies, procedures, forms, and update Train staff on new provisionsInventory BAs and update BAAsUpdate breach response plan; in particular, update risk assessment and address encryption
65Components Of An Effective Security Plan Policies & Procedures governing hardware and software.TestingAuditingContingency PlansCombination of hardware, firmware and software components that are designed to provide critical security functions with a very high degree of assurance that they will behave correctly;An application programming interface that allows operating systems and applications to use the security functions provided by the roots of trust; andA policy enforcement engine to enable the processing, maintenance and policy management of the mobile device.6565