HIPAA/HITECH Compliance Assurance Archives

OCR Launches Phase 2 of HIPAA Audit Program

HIPAA Phase 2 audiit is a part of the continued efforts to assess compliance with the HIPAA Privacy, Security and Breach Notification Rules by the HHS Office for Civil Rights (OCR). Audits are an important compliance tool for OCR that supplements OCR’s other enforcement tools, such as complaint investigations and compliance reviews. These tools enable OCR to identify best practices and proactively uncover and address risks and vulnerabilities to protected health information (PHI).

In its 2016 Phase 2 HIPAA Audit Program, OCR will review the policies and procedures adopted and employed by covered entities and their business associates to meet selected standards and implementation specifications of the Privacy, Security, and Breach Notification Rules. These audits will primarily be desk audits, although some on-site audits will be conducted.

The 2016 audit process begins with verification of an entity’s address and contact information. An email is being sent to covered entities and business associates requesting that contact information be provided to OCR in a timely manner. OCR will then transmit a pre-audit questionnaire to gather data about the size, type, and operations of potential auditees; this data will be used with other information to create potential audit subject pools.

If an entity does not respond to OCR’s request to verify its contact information or pre-audit questionnaire, OCR will use publically available information about the entity to create its audit subject pool. Therefore an entity that does not respond to OCR may still be selected for an audit or subject to a compliance review. Communications from OCR will be sent via email and may be incorrectly classified as spam. If your entity’s spam filtering and virus protection are automatically enabled, we expect entities to check their junk or spam email folder for emails from OCR.

The audit program is developing on pace and OCR is committed to transparency about the process. OCR will post updated audit protocols on its website closer to conducting the 2016 audits. The audit protocol will be updated to reflect the HIPAA Omnibus Rulemaking and can be used as a tool by organizations to conduct their own internal self-audits as part of their HIPAA compliance activities.

EHR 2.0 offers a secure and user-friendly online HIPAA compliance assessment toolkit for small medical practices with limited resources and time, to identify gap areas, prioritize solutions, and demonstrate compliance with federal regulations.

Demo of our Do-It-Yourself Online HIPAA Compliance Assessment Toolkit with HITECH

To understand more on the latest HIPAA phase 2 audits, listen to our 50mins webinar on “How to survive a HIPAA audit by HHS/OCR”

Checklist: Safe Disposal of Patient Data

A covered entity or business associate must remain in accordance with HIPAA 164.310d(1), Physical Safeguards – security procedures need to include: “Device and media controls. Implement policies and procedures that govern the receipt and removal of hardware and electronic media that contain electronic protected health information into and out of a facility, and the movement of these items within the facility.”

As you could interpret from these high level HIPAA data disposal requirement standards, HIPAA laws do not require specific steps, being vague as often the case and instructing rather to use “reasonable” safeguards when removing data from electronic devices. In order for healthcare organizations to have appropriate controls on patient data during disposal, they must properly safeguard used media.

Though the standard for disposing electronic patient data is defined vaguely, recent reported incidents and fines for insecure data disposal have increased. Out of 1113 incidents reported on HHS breach report, 46 of them are attributed to improper disposal of paper-based or electronic devices which contained PHI. Read more about the recent breach reports published by HHS here: http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/breachtool.html

Arguably the most important step in adhering to this HIPAA law requirement is determining electronic data storage devices that need to be disposed securely. Any device requiring electrical power to be capable of storing and/or processing data, such as those containing volatile memory and/or magnetic or optical storage, should be identified as such. This includes but is not limited to personal computers / hard drives, servers, mainframes, Personal Digital Assistants (PDAs), routers, firewalls, switches, tapes, diskettes, CDs, DVDs, cell phones, smart phones, tablets, printers with on board memory, multifunction devices, digital cameras, flash memory cards or SD cards, and Universal Serial Bus (USB) data storage devices.

Though inventorying all the above mentioned devices in a huge hospital setup is very complex, practically speaking, any electronic devices where Protected Health Information (PHI) data is stored need to be tracked. You could consider either using a simple inventory log or more sophisticated online database to keep track of the inventory of devices.

The security categorization of the patient data, along with internal environmental factors, should drive the decisions on how to deal with the media devices. Again, the key is to first think in terms of patient data confidentiality, then by media type.

There are several options available for disposal methods with different types of data, Health care organizations need to determine which method is preferable or needed, based on the confidentiality requirement of the data being disposed. Some of the most widely used methods are:

a) Overwriting: Overwriting of data means replacing previously stored data with a predetermined pattern of meaningless information. Overwriting is the more cost effective option to securely dispose data, as it allows the reuse of resources when possible.
b) Physical Destruction: Physical destruction includes but is not limited to disintegration, incineration, pulverization, and melting of the devices. Physical destruction needs to ensure that any possible restoration of the data from the device is not restorable. However, incineration must take place only in a licensed facility. Some of the approaches listed here involve outside professionals.
c) Cryptographic Sanitizing: Sanitization by cryptography works by first encrypting all data as it is written to the devices. The only way to read or recover data protected in this manner is to use a valid decryption key. Instant and thorough sanitizing occurs when the decryption key is destroyed.
d) Degaussing: Degaussing is a process whereby the magnetic media is thoroughly disrupted. Stored data in the electronic devices seldom can be used after degaussing, and the devices themselves are often left unusable.

Our advice and recommendations of checklist items to cover to securely dispose patient data:

Consideration of legal record retention requirements, along with company needs, prior to disposal. In most cases, at least 6-year worth of data is to be maintained before destroying. This requirement might also vary state-to-state.
Keep the data in a secure area prior to disposal.
Maintain records of devices where data was securely sanitized. This would include certificate, pictures, or other form of acknowledgement.
Training of all your staff on how direct disposal and deleting the data directly from the system is not sufficient. This could be combined with your annual HIPAA training of staff.
Identify the best possible method for securely disposing data discussed in the above categories.
Ensure backup copies of data are kept in a secure place, in case you ever need to refer to said data.

Examples of specific products / options available

For the list of software available to safely destruct data please click here >>

In addition, attend our complimentary webinar scheduled on 9/24. Register here >>

Additional resources:

http://www.nsa.gov/ia/government/MDG/NSA_CSS_EPL_04-02-B.PDF

Does my healthcare practice need to be HIPAA/HITECH certified?

We mentioned earlier in one of our blog posts that we would get back to you about the HIPAA/HITECH “Certification” question that lot of the healthcare practices are asking about … Certification by a third-party is not required for Covered Entities and Business Associates unlike PCI or ISO certification requirements. HIPAA/HITECH “certification” is not mandated in any way and no one is authorized to provide HIPAA/HITECH certification per se. Rather Covered Entities and Business Associates need to be in compliant with the new omnibus HIPAA Privacy, Security and Breach Notification rules. This is very clearly stated in HHS website: “A covered entity may make the business decision to have an external organization perform these types of services. It is important to note that HHS does not endorse or otherwise recognize private organizations’ “certifications” regarding the Security Rule, and such certifications do not absolve covered entities of their legal obligations under the Security Rule. Moreover, performance of a “certification” by an external organization does not preclude HHS from subsequently finding a security violation.” If you want to learn more about HHS’s position on getting HIPAA certification please go through the following links:

http://www.hhs.gov/ocr/privacy/hipaa/faq/securityrule/2003.html

http://www.techrepublic.com/article/industry-insiders-say-dont-bother-with-hipaa-certs/

The above discussion clearly concludes there’s no single certifying authority on HIPAA/HITECH rules. The assessment of HIPAA rules in your practice and implementation of required remediation could be technically performed by anyone (with no prior qualification). However, the purpose and intent of evaluation is two fold:

1) To genuinely secure patient data and implement required processes in place to avoid legal issues

2) To handle HHS Office for Civil Rights(OCR) audit request

In order to handle this HIPAA conundrum, we recommend at least conducting the initial HIPAA/HITECH assessment against the new rules by an externally qualified organization. Use the same methodologies and processes used by the external organization to conduct your periodic assessment for subsequent annual assessments. In addition, if there’re any major scope change in terms of your IT infrastructure, vendor upgrade or new business introduction have the assessment done by an external organization.

Only experience and industry knowledge will help apply the for your practice successfully.

There are quite a few organizations providing training and certification to acquire HIPAA expertise. Firms can benefit from their workers completing one or more of the established credentials, including:

1) Healthcare Information Security and Privacy Practiioner by ISC2 https://www.isc2.org/HCISPP/Default.aspx

2) AHIMA certification page (https://www.ahima.org/certification-careers/get-certified/),

3) CompTIA – (http://certification.comptia.org/getCertified/certifications/hittech.aspx).

No matter how you do your assessment, at least ensure the following 3 aspects of your HIPAA/HITECH rules::

1) Conducting a thorough security risk assessment of all your technological assets

2) Updating your information security policy document

3) Providing awareness training to your staff

$800,000 HIPAA Settlement in Medical Records Dumping Case

Parkview Health System, Inc. has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule with the U.S. Department of Health and Human Services Office for Civil Rights (OCR). Parkview will pay $800,000 and adopt a corrective action plan to address deficiencies in its HIPAA compliance program. Parkview is a nonprofit health care system that provides community-based health care services to individuals in northeast Indiana and northwest Ohio.

OCR opened an investigation after receiving a complaint from a retiring physician alleging that Parkview had violated the HIPAA Privacy Rule. In September 2008, Parkview took custody of medical records pertaining to approximately 5,000 to 8,000 patients while assisting the retiring physician to transition her patients to new providers, and while considering the possibility of purchasing some of the physician’s practice. On June 4, 2009, Parkview employees, with notice that the physician was not at home, left 71 cardboard boxes of these medical records unattended and accessible to unauthorized persons on the driveway of the physician’s home, within 20 feet of the public road and a short distance away from a heavily trafficked public shopping venue.

As a covered entity under the HIPAA Privacy Rule, Parkview must appropriately and reasonably safeguard all protected health information in its possession, from the time it is acquired through its disposition.

“All too often we receive complaints of records being discarded or transferred in a manner that puts patient information at risk,” said Christina Heide, acting deputy director of health information privacy at OCR. “It is imperative that HIPAA covered entities and their business associates protect patient information during its transfer and disposal.”

Parkview cooperated with OCR throughout its investigation. In addition to the $800,000 resolution amount, the settlement includes a corrective action plan requiring Parkview to revise their policies and procedures, train staff, and provide an implementation report to OCR.

To learn more about EHR 2.0 HIPAA Privacy, Security and Breach notification requirements, visit our service page:

http://ehr20.com/services/hipaa-hitech-compliance-assurance/

The Resolution Agreement can be found here:

Parkview HIPAA Settlement – Resolution Agreement from EHR 2.0

HIPAA compliance toolkit by HHS for Healthcare providers

A new security risk assessment (SRA) tool to help guide health care providers in small to medium sized offices conduct risk assessments of their organizations is now available from HHS. The SRA tool is the result of a collaborative effort by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Office for Civil Rights (OCR). The tool is designed to help practices conduct and document a risk assessment in a thorough, organized fashion at their own pace by allowing them to assess the information security risks in their organizations under the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. The application, available for downloading at www.HealthIT.gov/security-risk-assessment also produces a report that can be provided to auditors.

HIPAA requires organizations that handle protected health information to regularly review the administrative, physical and technical safeguards they have in place to protect the security of the information. By conducting these risk assessments, health care providers can uncover potential weaknesses in their security policies, processes and systems. Risk assessments also help providers address vulnerabilities, potentially preventing health data breaches or other adverse security events. A vigorous risk assessment process supports improved security of patient health data.

Conducting a security risk assessment is a key requirement of the HIPAA Security Rule and a core requirement for providers seeking payment through the Medicare and Medicaid EHR Incentive Program, commonly known as the Meaningful Use Program.

“Protecting patients’ protected health information is important to all health care providers and the new tool we are releasing today will help them assess the security of their organizations,” said Karen DeSalvo, M.D., national coordinator for health information technology. “The SRA tool and its additional resources have been designed to help health care providers conduct a risk assessment to support better security for patient health data.”

“We are pleased to have collaborated with the ONC on this project,” said Susan McAndrew, deputy director of OCR’s Division of Health Information Privacy. “We believe this tool will greatly assist providers in performing a risk assessment to meet their obligations under the HIPAA Security Rule.”

The SRA tool’s website contains a User Guide and Tutorial video to help providers begin using the tool. Videos on risk analysis and contingency planning are available at the website to provide further context.

The tool is available for both Windows operating systems and iOS iPads. Download the Windows version athttp://www.HealthIT.gov/security-risk-assessment. The iOS iPad version is available from the Apple App Store (search under “HHS SRA tool”).

The ONC is committed to improving the SRA tool in future update cycles, and is requesting that users provide feedback. Public comments on the SRA tool will be accepted at http://www.HealthIT.gov/security-risk-assessment until June 2, 2014.

10 Myths and Facts about HIPAA and Meaningful Security Risk Analysis

Conducting a security risk analysis to meet the standards of Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule is included in the meaningful use requirements of the Medicare and Medicaid EHR Incentive Programs. The following areas addresses some of the common myths about conducting a risk analysis, and provides facts and tips that can help you structure your risk analysis process.

Myth 1: The security risk analysis is optional for small providers

Fact: False. All providers who are “covered entities” under HIPAA are required to perform a risk analysis. In addition, all providers who want to receive EHR incentive payments must conduct a risk analysis.

Myth 2: Simply installing a certified EHR fulfills the security risk analysis MU requirement

Fact:

False. Even with a certified EHR, you must perform a full security risk analysis. Security requirements address all electronic protected health information you maintain, not just what is in your EHR.

Myth 3: My EHR vendor took care of everything I need to do about privacy and security

Fact: False. Your EHR vendor may be able to provide information, assistance, and training on the privacy and security aspects of the EHR product. However, EHR vendors are not responsible for making their products compliant with HIPAA Privacy and Security Rules. It is solely your responsibility to have a complete risk analysis conducted.

Myth 4: I have to outsource the security risk analysis

Fact: False. It is possible for small practices to do risk analysis themselves using self-help tools. However, doing a thorough and professional risk analysis that will stand up to a compliance review will require expert knowledge that could be obtained through services of an experienced outside professional.

Myth 5: A checklist will suffice for the risk analysis requirement

Fact: False. Checklists can be useful tools, especially when starting a risk analysis, but they fall short of performing a systematic security risk analysis or documenting that one has been performed.

Myth 6: There is a specific risk analysis method that I must follow

Fact: False. A risk analysis can be performed in countless ways. OCR has issued Guidance on Risk Analysis Requirements of the Security Rule. This guidance assists organizations in identifying and implementing the most effective and appropriate safeguards to secure e-PHI.

Myth 7: My security risk analysis only needs to look at my EHR

Fact: False. Review all electronic devices that store, capture, or modify electronic protected health information. Include your EHR hardware and software and devices that can access your EHR data (e.g., your tablet computer, your practice manager’s mobile phone). Remember that copiers also store data. Please see U.S. Department of Health and Human Services (HHS) guidance on remote use.

Myth 8: I only need to do a risk analysis once

Fact: False. To comply with HIPAA, you must continue to review, correct or modify, and update security protections.

Myth 9: Before I attest for an EHR incentive program, I must fully mitigate all risks

Fact: False. The EHR incentive program requires correcting any deficiencies (identified during the risk analysis) according to the timeline established in the provider’s risk management process, not the date the provider chooses to submit meaningful use attestation. The timeline needs to meet the requirements under 45 CFR 164.308(a)(1), including the requirement to “Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with [45 CFR ]§164.306(a).”

Myth 10: Each year, I’ll have to completely redo my security risk analysis

Fact: False. Perform the full security risk analysis as you adopt an EHR. Each year or when changes to your practice or electronic systems occur, review and update the prior analysis for changes in risks. Under meaningful use, reviews are required for each EHR reporting period. For EPs, the EHR reporting period will be 90 days or a full calendar year, depending on the EP’s year of participation in the program.

Source: CMS

YouTube Best Practices and HIPAA Compliance

Video has become central to our lives, both business and personal. The use of video platforms, notably YouTube, can have important business implications for a healthcare system as well as potential HIPAA violation issues if used incorrectly. In addition, being aware of patient use of video (and public posting thereof) can present unintentional HIPAA consequences. In this session we’ll review the best practices for video use and review potential pitfalls.

Join our webinar to learn about Youtube best practices and HIPAA compliance.

Date:5/1/2014

Time: Noon to 1:00 p.m. EST

Price: $99

Our 60-minute vendor-neutral educational session on social media trends, best

practices, and compliance for health care professionals will cover:

Video pervasiveness
Use for education, engagement, & branding
Best Practices
Developing a video strategy
HIPAA compliance review
Q & A

Includes

Access to recorded webinar
Compliance best practices
Compliance training material for staff

Speaker:

Janet M. Kennedy is a social media strategy & community management specialist in LinkedIn, Facebook & Twitter community development, customer engagement and triggering action in support of customers. She is a well-rounded marketing professional with 15+ years experience developing strategic plans that drive traffic and sales utilizing classic off-line and online marketing tools. Strategic marketer in digital and traditional media. View full bio>>

Do I need to address all identified security risks?

Before conducting meaningful security risk analysis of ePHI, it is important that practitioners clearly understand the terminologies:

Risk is the level of exposure and potential impact of threats on the confidentiality, integrity, and availability of electronic Protected Health Information (ePHI).

Threats are all factors that can have a negative impact on ePHI.

Threats may be:

– Intentional (e.g., malicious intent); or

– Unintentional (e.g., misconfigured security role assignment in EHR system, data entry error).

Threat sources include:

– Natural (e.g., floods, earthquakes, storms, tornados);

– Human (e.g., intentional, such as identity thieves, hackers, spyware authors; unintentional, such as data entry error, accidental deletions, improper disclosure); or

– Environmental (e.g., power surges and spikes, hazmat contamination pollution).

Vulnerabilities are flaws or weaknesses in an EHR or PMS system’s security procedure, design, implementation, or control that could be intentionally or unintentionally exercised by a threat.

Impact is a negative quantitative and/or qualitative assessment of a vulnerability being exercised on the confidentiality, integrity, and availability of ePHI.

Covering how to identify security risks during your meaningful use security risk assessment process is beyond the scope of this article. Rather, our focus will be on strategizing how to address the identified risks. As demonstrated by recent announcements from major retailers and healthcare providers on data breaches, identifying security risks in the technology systems is only half the battle. Strategically addressing the risks identified in the risk analysis is the key to maintain the upper hand. The majority of risk identification will be focused on analyzing your different systems, including your EHR programs, network, wireless infrastructure, desktops/laptops, mobile devices, and other portable devices including USB thumb drive, backup tapes, etc.

In terms of addressing all identified risks, it’s effectively impossible to address all of them, as security experts generally agree that security threats are constantly evolving. For instance, by the time you have reasonably secured all desktops and laptops, your ePHI also may be on mobile devices and/or with cloud service providers. It’s said in the industry that you cannot run a business with zero risk, and this notion very much applies to the information security risk area.

Prioritization of risk should take into account all information gathered and determinations made by analyzing the likelihood of threat occurrence and its resulting impact. The risk-level determination may be performed by assigning a risk-level based on the average of the assigned likelihood and impact levels. A risk-level matrix, such as the sample depicted below, can be used to assist in determining risk levels.

It’s possible for most organizations to address the risks using one or more of the following options:

By accepting the risks
By mitigating the risks
By transferring the risks

It should be noted that not all possible recommended security controls can always be implemented to reduce risks identified. To determine which are most required and appropriate, a cost-benefit analysis needs to be conducted for the recommended controls to demonstrate that the costs of implementing the controls will be justified by the reduction in the level of risk. In addition to cost, organizations should consider the operational impact and feasibility of introducing the recommended security controls into the operating environment.

Your overall objective for addressing any risks needs to be minimizing the probability and consequences of adverse events to your organization, along with managing the risks within acceptable levels

Download Free FAQ on MU EHR Incentive Audit

Listen to our on-demand webinar on security risk analysis:

Shasta Regional Medical Center Settles HIPAA Security Case for $275,000

Cybersecurity Maturity Model Certification

Shasta Regional Medical Center (SRMC) has agreed to a comprehensive corrective action plan to settle an investigation by the U.S. Department of Health and Human Services (HHS) about potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and will pay a $275,000 monetary settlement.
The HHS Office for Civil Rights (OCR) opened a compliance review of SRMC following a Los Angeles Times article which indicated two SRMC senior leaders had met with media to discuss medical services provided to a patient. OCR’s investigation indicated that SRMC failed to safeguard the patient’s protected health information (PHI) from impermissible disclosure by intentionally disclosing PHI to multiple media outlets on at least three separate occasions, without a valid written authorization. OCR’s review indicated that senior management at SRMC impermissibly shared details about the patient’s medical condition, diagnosis and treatment in an email to the entire workforce. Further, SRMC failed to sanction its workforce members for impermissibly disclosing the patient’s records pursuant to its internal sanctions policy.

In addition to the $275,000 monetary settlement, a corrective action plan (CAP) requires SRMC to update its policies and procedures on safeguarding PHI from impermissible uses and disclosures and to train its workforce members. The CAP also requires fifteen other hospitals or medical centers under the same ownership or operational control as SRMC to attest to their understanding of permissible uses and disclosures of PHI, including disclosures to the media.

Shasta agreement from EHR 2.0