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Healthcare Compliance 101

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OCR Awarded the 4th Largest Settlement In HIPAA Vioations

Judge rules in favor of OCR and requires a Texas cancer center to pay $4.3 million in penalties for HIPAA violations

 A U.S. Department of Health and Human Services Administrative Law Judge (ALJ) has ruled that The University of Texas MD Anderson Cancer Center (MD Anderson) violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules and granted summary judgment to the Office for Civil Rights (OCR) on all issues, requiring MD Anderson to pay $4,348,000 in civil money penalties to OCR. This is the second summary judgment victory in OCR’s history of HIPAA enforcement and the $4.3 million is the fourth largest amount ever awarded to OCR by an ALJ or secured in a settlement for HIPAA violations.

MD Anderson is both a degree-granting academic institution and a comprehensive cancer treatment and research center located at the Texas Medical Center in Houston. OCR investigated MD Anderson following three separate data breach reports in 2012 and 2013 involving the theft of an unencrypted laptop from the residence of an MD Anderson employee and the loss of two unencrypted universal serial bus (USB) thumb drives containing the unencrypted electronic protected health information (ePHI) of over 33,500 individuals. OCR’s investigation found that MD Anderson had written encryption policies going as far back as 2006 and that MD Anderson’s own risk analyses had found that the lack of device-level encryption posed a high risk to the security of ePHI. Despite the encryption policies and high risk findings, MD Anderson did not begin to adopt an enterprise-wide solution to implement encryption of ePHI until 2011 , and even then it failed to encrypt its inventory of electronic devices containing ePHI between March 24, 2011 and January 25, 2013. The ALJ agreed with OCR’s arguments and findings and upheld OCR’s penalties for each day of MD Anderson’s non-compliance with HIPAA and for each record of individuals breached.

“OCR is serious about protecting health information privacy and will pursue litigation, if necessary, to hold entities responsible for HIPAA violations,” said OCR Director Roger Severino. “We are pleased that the judge upheld our imposition of penalties because it underscores the risks entities take if they fail to implement effective safeguards, such as data encryption, when required to protect sensitive patient information.”

MD Anderson claimed that it was not obligated to encrypt its devices, and asserted that the ePHI at issue was for “research,” and thus was not subject to HIPAA’s nondisclosure requirements. MD Anderson further argued that HIPAA’s penalties were unreasonable. The ALJ rejected each of these arguments and stated that MD Anderson’s “dilatory conduct is shocking given the high risk to its patients resulting from the unauthorized disclosure of ePHI,” a risk that MD Anderson “not only recognized, but that it restated many times.”

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Security Management Process

The standard requires your practice to evaluate your risks and determine how you will prevent, detect, contain, and correct security violations.  Evaluate what could go wrong, and then establish a risk management plan to serve as a guidance tool in the event something does go wrong, and establish a plan to correct security violations.

Four Required Implementation Specifications:

Risk Analysis
Risk Management
Sanction Policy
Information System Activity Review


 

Contingency Plan

Plan A… B… Contingency Plan!

 The purpose of any contingency plan is to allow an organization to return to its daily operations as quickly as possible after an unforeseen event.  The contingency plan protects resources, minimizes customer inconvenience and identifies key staff, assigning specific responsibilities in the context of the recovery.

 Contingency plans are critical to protecting the availability, integrity, and security of data during unexpected adverse events. Contingency plans should consider not only how to respond to disasters such as fires and floods, but also how to respond to cyberattacks. Cyberattacks using malicious software such as ransomware may render an organization’s data unreadable or unusable. In the event data is compromised due to a cyberattack, restoring the data from backups may be the only option to recover the data and restore normal business operations.

What Does a Contingency Plan Do?

ü Contingency Plan:  Focused on the steps to respond and recover operations in the event of an emergency or other disruption to normal operations.  Its major objectives are to ensure: (1) the containment of damage or injury to, or loss of, property, personnel, and data; and (2)the continuity of the key operations of the organization.

 Contingency plans aren’t just a good idea; regulations for certain industries require contingency planning.  For example, the HIPAA Security Rule requires that HIPAA covered entities and business associates establish and implement a contingency plan.[1]

 What’s Required for a HIPAA Contingency Plan?

ü Disaster Recovery Plan:  Focused on restoring an organization’s protected health data.

ü Emergency Mode Operation Plan (or Continuity of Operations):  Focused on maintaining and protecting critical functions that protect the security of protected health data.

ü Data Backup Plan:  Focused on regularly copying protected health data to ensure it can be restored in the event of a loss or disruption.

 Items to Address as Part of a HIPAA Contingency Plan

ü Applications and Data Criticality Analysis: Focused on identifying what applications and data are critical for the contingency plan.

ü Testing and Revisions: Focused on testing your contingency plan and revising any identified deficiencies.

 Key Steps on the road to Contingency Planning:

Make it Policy:  A formal policy provides the authority and guidance necessary to develop an effective contingency plan.

Identify what is Critical:  Knowing what systems and data are critical to operations will help prioritize contingency planning and minimize losses.

 Identify Risks, Threats and Preventative Controls:  Perform a risk analysis to identify the various risks that your business may face.  What has the potential to significantly disrupt or harm your operations and data?

    Contingency Plans & Risk Analysis:  The need for contingency plans appears as a result of a thorough and accurate analysis of the risks that your organization faces.  The end result of a risk analysis can provide a list of potential threats, risks, and preventative controls.  Prioritization of critical systems and information will help identify where to focus planning efforts.

 Create Contingency Procedures:  Establish the specific guidelines, parameters, and procedures when enacting the contingency plan and for the recovery of systems and data.  Here’s where the Disaster Recovery Plan, Emergency Mode Operation Plan and Data Backup Plan will fill in the overarching contingency plan.  Keep in mind:

o   The goal is to maintain critical operations and minimize loss.

o   Define time periods – What must be done during the first hour, day, or week?

o   Establish Plan Activation – What event(s) will cause the activation of the contingency plan?  Who has the authority to activate the contingency plan?

o   Use plain language – the plan should be understandable to all types of employees.

 Operationalize & Maintain the Plan:  Integrate the plan into normal business operations.

o   Communicate and share the plan and roles and responsibilities with the organization.

o   Establish a testing (exercise) schedule for the plan, to identify gaps and ensure updates for plan effectiveness and increase organizational awareness.

o   Review the plan on a regular basis and situationally when there are technical, operational, environmental, or personnel changes in the organization.

 Don’t wait for a disaster to happen before designing and implementing a contingency plan.

Reprinted from the Office of Civil Rights

Phishing – Cyber Attacks

Phishing is a type of cyber-attack used to trick individuals into divulging sensitive information via electronic communication by impersonating a trustworthy source.  For example, an individual may receive an e-mail or text message informing the individual that their password may have been hacked. The phishing email or text may then instruct the individual to click on a link to reset their password. In many instances, the link will direct the individual to a website impersonating an organization’s real web site (e.g., bank, government agency, email service, retail site) and ask for the individual’s login credentials (username and password).  Once entered into the fake website, the third party that initiated the phishing attack will have the individual’s login credentials for that site and can begin other malicious activity such as looking for sensitive information or using the individual’s email contact list to send more phishing attacks.  Alternatively, rather than capture login credentials, the link on the phishing message may download malicious software on to the individual’s computer.  Phishing messages could also include attachments, such as a spreadsheet or document, containing malicious software that executes when such attachments are opened.  Phishing is one of the primary methods used to distribute malicious software, including ransomware.

Individuals must remain vigilant in their efforts to detect and not fall prey to phishing attacks because these attacks are becoming more sophisticated and harder to detect.  Phishing attacks take advantage of popular holidays by impersonating messages from shipping vendors and ecommerce sites.  Similarly, phishing attacks regarding tax refunds are common during tax season (March and April).  A specific type of phishing attack, known as spear phishing, targets specific individuals within an organization. For example, a spear phishing attack could target an individual in the IT, accounting or finance department of an organization by impersonating the individual’s supervisor and directing the individual to a malicious website or to download a file containing a malicious program.  One of the primary methods of combating phishing attacks of all kinds is through user awareness.  OCR included information on cybersecurity training and awareness programs in its July 2017 newsletter.[1]

Tips to avoid becoming a victim of a phishing attack include:

  • Be wary of unsolicited third party messages seeking information.  If you are suspicious of an unsolicited message, call the business or person that sent the message to verify that they sent it and that the request is legitimate.
  • Be wary of messages even from recognized sources. Messages from co-workers or a supervisor as well as messages from close relatives or friends could be sent from hacked accounts used to send phishing messages.
  • Be cautious when responding to messages sent by third parties.  Contact information listed in phishing messages such as email addresses, web sites, and phone numbers could redirect you to the malicious party that sent the phishing message.  When verifying the contents of a message, use known good contact information or, for a business, the contact information provided on its web site.
  • Be wary of clicking on links or downloading attachments from unsolicited messages.  Phishing messages could include links directing people to malicious web sites or attachments that execute malicious software when opened.
  • Be wary of even official looking messages and links.  Phishing messages may direct you to fake web sites mimicking real websites using web site names that appear to be official, but which may contain intentional typos to trick individuals.  For example, a phishing attack may direct someone to a fake website that uses 1’s (ones) instead of l’s (i.e., a11phishes vs. allphishes).
  • Use multi-factor authentication.  Multi-factor authentication reduces the possibility that someone can hack into your account using only your password.  OCR’s November 2016 cybersecurity newsletter included information on types of authentication.[2]
  • Keep anti-malware software and system patches up to date.  If you do fall for a phishing scam, anti-malware software can help prevent infection by a virus or other malicious software.  Also, ensuring patches are up to date reduces the possibility that malicious software could exploit known vulnerabilities of your computer’s or mobile device’s operating system and applications.
  • Back up your data.  In the event that malicious software, such as ransomware, does get installed on your computer, you want to make sure you have a current backup of your data.  Malicious software that deletes your data or holds it for ransom may not be retrievable.  Robust, frequent backups may be the only way to restore data in the event of a successful attack.  Also, be sure to test backups by restoring data from time to time to ensure that the backup strategy you have in place is effective.

Phase Two HIPAA Audits Have Begun

July 12, 2016

OCR’s Phase Two HIPAA Audits Have Begun

Phase Two of OCR’s HIPAA audit program, which officially began a couple of months ago, has officially kicked into high gear.   Selected covered entities have now received notification letters regarding their inclusion in the desk audit portion of the audit program.  Letters were delivered on Monday, July 11, 2016 via email to 167 health plans, health care providers and health care clearinghouses (covered entities).  The desk audits will examine the selected entities’ compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules.

The desk audits are focused examinations of documentation of entity compliance with certain requirements of the HIPAA Rules (see table below).  OCR selected these provisions for focus during the desk audits because our pilot audits, as well as our enforcement activities, have surfaced these provisions as frequent areas of noncompliance.  Entities received two email communications, which were sent to the contact information confirmed by the entity during the pre-audit phase of the program. Nevertheless, these emails may be incorrectly classified as spam in the recipient’s email service.  Covered entities should monitor their spam filtering and junk mail folders for emails from OSOCRAudit@hhs.gov.   One e-mail includes a notification letter providing instructions for responding to the desk audit document request, the timeline for response, and a unique link for each organization to submit documents via OCR’s secure online portal. A second email contains an additional request to provide a listing of the entity’s business associates and also provides information about an upcoming webinar, where OCR will explain the desk audit process for auditees and take their questions.    Entities have 10 business days, until July 22, 2016, to respond to the document requests. Desk audits of business associates will follow this fall.

For more information, see http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/index.html.

Requirements Selected for Desk Audit Review

Privacy Rule Notice of Privacy Practices & Content Requirements   [§164.520(a)(1) & (b)(1)]
Provision of Notice – Electronic Notice   [§164.520(c)(3)]
Right to Access  [§164.524(a)(1), (b)(1), (b)(2), (c)(2), (c)(3),  (c)(4), (d)(1), (d)(3)]
Breach Notification Rule Timeliness of Notification  [§164.404(b)]
Content of Notification  [§164.404(c)(1)]
Security Rule Security Management Process —  Risk Analysis  [§164.308(a)(1)(ii)(A)]
Security Management Process — Risk Management  [§164.308(a)(1)(ii)(B)]

 

From the Office of Civil Rights (OCR)

June  7, 2016

What’s in Your Third-Party Application Software?

Recently, it has been reported that third-party application software security vulnerabilities are on the rise.  Third-party application software is designed to work within operating systems and to assist users in executing tasks on computers and other devices.  For example, Microsoft Windows 7 is an operating system that controls the way computers work and how other programs function, but Acrobat Adobe is a third-party application that is utilized by computer users to create, modify, and read PDF files.  Many Covered Entities and Business Associates may think their computers and devices that utilize operating systems are secure because the Covered Entities and Business Associates are deploying operating-system updates, but many systems are still at risk from third-party software.

According to a recent study, a majority of companies use third-party applications or software, but less than 1 in 5 companies has performed verification on these third-party software.  Also, it was reported in companies that install their operating-system patches, a fair amount have third-party software that remain unpatched.

Furthermore, third-party software may have numerous security vulnerabilities that do not stem from the applications themselves.  Misconfigured servers, improper files settings, and outdated software versions may contribute to third-party software security vulnerabilities.

Covered Entities and Business Associates Should Consider:

Testing Software Prior to Installation

Covered Entities and Business Associates should define the criteria they are willing to accept for safe third-party applications, including open source and public domain applications. Applications should meet the corporate standards set by the entities and also satisfy compliance requirements, and entities should test against these criteria.

The purpose of conducting security testing on software is to reveal flaws in its security mechanisms and finding the vulnerabilities or weakness of software applications. For example, conducting testing may find out how vulnerable a system may be to flaws in applications and determine whether data and resources are protected from potential intruders.

Covered Entities and Business Associates should work with their Business Associate vendors to test their applications for security vulnerabilities prior to installation, and on a regular basis after the software has been installed.

Installing Software Patches or Updated Versions

Software patches repair “bugs” in applications and software programs.  Patches are updates that fix a particular problem or vulnerability within a program.  Covered Entities and Business Associates should be installing patches or updating the software versions promptly and on a continuous basis.  The majority of software developers disclose their security flaws to public; however, attackers exploit these known vulnerabilities if Covered Entities and Business Associates do not fix the security flaws in a timely manner.

Though applying patches is essential to ensure the security of information systems, patches should be assessed prior to deployment to determine the risk they pose to the Covered Entity’s information systems.

Reviewing Software License Agreements

A software license agreement (also known as end user license agreement (EULA)) highlights the risks that can make ePHI vulnerable. Data can be compromised if Covered Entities and Business Associates ignore the language in a software license agreement, as such behavior can expose a computer and its connected networks and systems to security risks.

Software license agreements are legal binding agreements that can have restrictions on how the software can be used; the agreements can require entities to agree to certain conditions when using the software, and can also limit their ability to sue for damages.

To protect information systems and networks from security and privacy problems related to EULAs, US-CERT recommends that entities:

  1. Review the Software EULA – Before installing any software, take the time to read its EULA.
  2. Beware of Firewall Prompts When Installing Software – During installation, if your firewall generates a prompt asking whether you want to allow certain inbound or outbound connections, proceed with caution. Verify that the software requires changes to your firewall settings for normal operation and that you are comfortable with this operation.
  3. Consider the Software Publisher – If you are not familiar with the company or organization that published the software, review the software EULA with added scrutiny.

Resources:

United States Computer Emergency Readiness Team (US-CERT): www.us-cert.gov(Software guidance)

HIPAA Rights to Access Health Information

New Consumer Tools Explain HIPAA Right to Access Health Information

 

Earlier this year, the HHS Office for Civil Rights (OCR) released comprehensive guidance on the right of individuals under the Health Insurance Portability and Accountability Act (HIPAA) to access and receive copies of their health information.  Providing individuals with easy access to their health information empowers them to be more in control of decisions regarding their health and well-being.  Individuals who can access their health information are better able to monitor chronic conditions, adhere to treatment plans, find and fix errors, and directly contribute their information to research.

 

This guidance is available to all members of the public – but was initially aimed primarily at entities covered by HIPAA. In addition, individuals need tools to help them understand the right to access their health information.   To make OCR’s HIPAA access guidance more understandable for individuals, we teamed up with the HHS Office of the National Coordinator for Health IT to create easy-to-understand tools, including videos and an “infographic,” an illustrated fact sheet.  The videos have been recorded in English, but are available with a Spanish caption.

 

  1. Individuals’ Right under HIPAA to Access their Health Information

This video addresses the basics of the HIPAA access right.  For example, the video explains the individual’s right to access their medical records and that access may only be denied in very limited circumstances.

  1. HIPAA Access Associated Fees and Timing

This video explains that individuals may be charged reasonable fees for copies of their health information that include only certain labor, supply, and postage costs (where applicable) associated with making and delivering the copy requested by the individual.  The video also explains when access should be free, such as through a patient portal.

  1. HIPAA Access and Third Parties

This video focuses on the right of individuals to request that their health information be sent to a third party of their choice, such as a family member or even a mobile application.

  1. HIPAA Access Infographic

This one-page fact sheet, with illustrations, provides an overall summary of key aspects of the HIPAA right of individuals to access and receive a copy of their health information.

 

To learn more about individuals’ rights under HIPAA to access their health information, please visit:http://www.hhs.gov/blog/2016/01/07/understanding-individuals-right-under-hipaa-access-their.html

Unauthorized Filming of Your Patient Could Result in HIPAA Violation

Unauthorized Filming for “NY Med” Results in $2.2 Million Settlement with New York Presbyterian Hospital

 

Today, the Department of Health and Human Services, Office for Civil Rights (OCR) announced that it has reached a $2.2 million settlement with New York Presbyterian Hospital (NYP) for the egregious disclosure of two patients’ protected health information (PHI) to film crews and staff during the filming of “NY Med,” an ABC television series, without first obtaining authorization from the patients. In particular, OCR found that NYP allowed the ABC crew to film someone who was dying and another person in significant distress, even after a medical professional urged the crew to stop.

 

“This case sends an important message that OCR will not permit covered entities to compromise their patients’ privacy by allowing news or television crews to film the patients without their authorization,” said Jocelyn Samuels, OCR’s Director.  “We take seriously all complaints filed by individuals, and will seek the necessary remedies to ensure that patients’ privacy is fully protected.”

 

By allowing individuals receiving urgent medical care to be filmed without their authorization by members of the media, NYP’s actions blatantly violate the HIPAA Rules, which were specifically designed to prohibit the disclosure of individual’s PHI, including images, in circumstances such as these.

 

OCR also found that NYP failed to safeguard protected health information and allowed ABC film crews virtually unfettered access to its health care facility, effectively creating an environment where PHI could not be protected from impermissible disclosure to the ABC film crew and staff.  In addition to the $2.2 million, OCR will monitor NYP for two years as part of this settlement agreement, helping ensure that NYP will remain compliant with its HIPAA obligations while it continues to provide care for patients.

A Risk Assessment is a Necessary Requirement of a HIPPA Compliance Program

December 14, 2015

$750,000 HIPAA SETTLEMENT UNDERSCORES THE NEED FOR ORGANIZATION WIDE RISK ANALYSIS

 The University of Washington Medicine (UWM) has agreed to settle charges that it potentially violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule by failing to implement policies and procedures to prevent, detect, contain, and correct security violations.  UWM is an affiliated covered entity, which includes designated health care components and other entities under the control of the University of Washington, including University of Washington Medical Center, the primary teaching hospital of the University of Washington School of Medicine.  Affiliated covered entities must have in place appropriate policies and processes to assure HIPAA compliance with respect to each of the entities that are part of the affiliated group.   The settlement includes a monetary payment of $750,000, a corrective action plan, and annual reports on the organization’s compliance efforts.

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) initiated its investigation of the UWM following receipt of a breach report on November 27, 2013, which indicated that the electronic protected health information (e-PHI) of approximately 90,000 individuals was accessed after an employee downloaded an email attachment that contained malicious malware. The malware compromised the organization’s IT system, affecting the data of two different groups of patients:  1) approximately 76,000 patients involving a combination of patient names, medical record numbers, dates of service, and/or charges or bill balances; and 2) approximately 15,000 patients involving names, medical record numbers, other demographics such as address and phone number, dates of birth, charges or bill balances, social security numbers, insurance identification or Medicare numbers.

OCR’s investigation indicated UWM’s security policies required its affiliated entities to have up-to-date, documented system-level risk assessments and to implement safeguards in compliance with the Security Rule. However, UWM did not ensure that all of its affiliated entities were properly conducting risk assessments and appropriately responding to the potential risks and vulnerabilities in their respective environments.

The Resolution Agreement and Corrective Action Plan can be found on the OCR website at:http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/uwm/index.html

The HHS Press Release can be found at:  http://www.hhs.gov/about/news/2015/12/14/750000-hipaa-settlement-underscores-need-for-organization-wide-risk-analysis.html

HHS offers guidance on how your organization can conduct a HIPAA Risk Analysis:  http://www.healthit.gov/providers-professionals/security-risk-assessment

To learn more about non-discrimination and health information privacy laws, your civil rights, and privacy rights in health care and human service settings, and to find information on filing a complaint, visit us at http://www.hhs.gov/ocr/office

Understanding Individuals Rights Under HIPPA

January 7, 2016

 

Understanding Individuals’ Right under HIPAA to Access their Health Information

The HIPAA Privacy Rule has always provided individuals with the right to access and receive a copy of their health information from their doctors, hospitals and health insurance plans.  This right is critical to enabling individuals to take ownership of their health and well-being.  Individuals with access to their health information are better able to monitor chronic conditions, adhere to treatment plans, find and request fixes to errors in their records, track progress in wellness or disease management programs, and directly contribute their information to research.  As the health care system evolves and transforms into one supported by rapid, secure exchange of electronic health information and more targeted treatments discovered through the new precision medicine model of patient-powered research, it is more important than ever for individuals to have ready access to their health information. Unfortunately, based on recent studies and our own enforcement experience, far too often individuals face obstacles to accessing their health information, even from entities required to comply with the HIPAA Privacy Rule.  This must change.

Today, we took an important step toward ensuring that individuals can take advantage of their HIPAA right of access. We released a fact sheet and the first in a series of topical Frequently Asked Questions (FAQs) to further clarify individuals’ core right under HIPAA to access and obtain a copy of their health information.  This set of FAQs addresses the scope of information covered by HIPAA’s access right, the very limited exceptions to this right, the form and format in which information is provided to individuals, the requirement to provide access to individuals in a timely manner, and the intersection of HIPAA’s right of access with the requirements for patient access under the HITECH Act’s Electronic Health Record (EHR) Incentive Program.

We will continue to develop additional guidance and other tools as necessary to ensure that individuals understand and can exercise their right to access their health information.  In addition, the Office for Civil Rights will work with the White House Social and Behavioral Sciences Team and the Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) to produce consumer-friendly resources, including sample communications tools to encourage patients to access their digital health information.

The first set of materials may be found on OCR’s website at: http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html

To learn more about non-discrimination and health information privacy laws, your civil rights, and privacy rights in health care and human service settings, and to find information on filing a complaint, visit us at http://www.hhs.gov/ocr/

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