OCR Encourages Healthcare Organizations to Conduct a Gap Analysis

In its April 2018 cybersecurity newsletter, OCR draws attention to the benefits of performing a gap analysis in addition to a risk analysis. The latter is required to identify risks and vulnerabilities that could potentially be exploited to gain access to ePHI, while a gap analysis helps healthcare organizations and their business associates determine the extent to which an entity is compliant with specific elements of the HIPAA Security Rule.

The Risk Analysis

HIPAA requires covered entities and their business associates to perform a comprehensive, organization-wide risk analysis to identify all potential risks to the confidentiality, integrity, and availability of ePHI – 45 CFR § 164.308(a)(1)(ii)(A).

If a risk analysis is not performed, healthcare organizations cannot be certain that all potential vulnerabilities have been identified. Vulnerabilities would likely remain that could be exploited by threat actors to gain access to ePHI.

While HIPAA does not specify the methodology that should be used when conducting risk analyses, OCR explained in its newsletter that risk analyses must contain certain elements:

  • A comprehensive assessment of all risks to all ePHI, regardless of where the data is created, received, maintained, or transmitted, or the source or location of ePHI.
  • All locations and information systems where ePHI is created, received, maintained, or transmitted must be included in the risk analysis, so an inventory should be created that includes all applications, mobile devices, communications equipment, electronic media, networks, and physical locations in addition to workstations, servers, and EHRs.
  • The risk analysis should cover technical and non-technical vulnerabilities, the latter includes policies and procedures, with the former concerned with software flaws, weaknesses in IT systems, and misconfigured information systems and security solutions.
  • The effectiveness of current controls must be assessed and documented, including all security solutions such as AV software, endpoint protection systems, encryption software, and the implementation of patch management processes.
  • The likelihood that a specific threat will exploit a vulnerability and the impact should a vulnerability be exploited must be assessed and documented.
  • The level of risk should be determined for any specific threat or vulnerability. With a risk level assigned, it will be easier to determine the main priorities when mitigating risks through the risk management process.
  • The risk analysis must be documented in sufficient detail to demonstrate that a comprehensive, organization-wide risk analysis has been conducted, and that the risk analysis was accurate and covered all locations, devices, applications, policies, and procedures involving ePHI. OCR will request this documentation in the event of an investigation or compliance audit.
  • A risk analysis is not a one-time event to ensure compliance with the HIPAA Security Rule – It must part of an ongoing process for continued compliance. The process must be regularly reviewed and updated, and risk analyses should be performed regularly. HIPAA does not stipulate how frequently a full or partial risk analysis should be performed. OCR suggests risk analyses are most effective when integrated into business processes.

Once a risk analysis has been performed, all risks and vulnerabilities identified must be addressed through a HIPAA-compliant security risk management process – 45 CFR § 164.308(a)(1)(ii)(B) – to reduce those risks to a reasonable and appropriate level.

Guidance on conducting an organization-wide risk analysis can be found on this link (HHS)

The Gap Analysis

A gap analysis is not a requirement of HIPAA Rules, although it can help healthcare organizations confirm that the requirements of the HIPAA Security Rule have been satisfied.

A gap analysis can be used as a partial assessment of an organizations compliance efforts or could cover all provisions of the HIPAA Security Rule.  Several gap analyses could be performed, each assessing a different set of standards and implementation specifications of the HIPAA Security Rule.

The gap analysis can give HIPAA-covered entities and their business associates an overall view of their compliance efforts, can help them discover areas where they are yet compliant with HIPAA Rules, and identify any gaps in the controls that have already been implemented.

Note that a gap analysis is not equivalent to a risk analysis, as it does not cover all possible risk to the confidentiality, integrity, and availability of ePHI as required by 45 C.F.R. §164.308(a)(1)(ii)(A).

OCR offers the following example of a simple gap analysis:

Source: OCR

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Former Berkeley Medical Center Worker Gets 5 Years’ Probation for Identity Theft

In federal court on Monday, Chief U.S. District Judge Gina M. Groh sentenced a former Berkeley Medical Center worker to 5 years’ probation for her role in an identity theft scam. In addition to probation, Angela Dawn Roberts, 42, of Stephenson, VA, must pay $22,000 in restitution.

Angela Dawn Roberts, also known as Angela Dawn Lee, had been working for WVU University Healthcare since 2014.

Roberts was employed to schedule appointments for patients at two medical centers – Berkeley Medical Center and Jefferson Medical Center – which provided her with access to patients’ protected health information.

Roberts copied sensitive information onto paper, including names, birth dates, and Social Security numbers, and in some cases printed copies of identity documents.

On January 19, 2017, Roberts was suspended following an internal investigation into data theft which was alleged to have occurred on June 27, 2016.

She was fired on January 27, 2017 and was prosecuted for stealing patient health information. Approximately 7,000 patients whose information was accessed by Roberts were notified of the risk of identity theft and fraud as a precaution.

Angela Dawn Roberts admitted stealing the protected health information of 10 patients and pleaded guilty to one count of identity theft. The plea agreement was filed in July.

The stolen information was passed to her co-defendant, Ajarhi Savimbi Roberts. Ajarhi Savimbi Roberts was charged with bank fraud in a 36-count indictment. He pleaded guilty and is scheduled to be sentenced on May 21.

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Virtua Medical Group Fined $418,000 for Violations of HIPAA and New Jersey Law

Virtua Medical Group – A network of physicians affiliated to over 50 medical practices in New Jersey – has been financially penalized by the New Jersey Attorney General’s Office for failing to protect the privacy of more than 1,650 patients whose medical information was accessible online without the need for any authentication.

The electronic protected health information was exposed as a result of a misconfigured server. The error occurred at a business associate of the medical group – Best Medical Transcription – which had been provided with audio files to transcribe medical notes.

Best Medical Transcription was contracted to transcribe dictations of medical notes, reports, and letters from three New Jersey medical practices: Virtua Pain and Spine Specialists in Voorhees, Virtua Gynecological Oncology Specialists, and Virtua Surgical Group in Hainesport.

The transcribed notes were uploaded to a password-protected FTP website; however, in January 2016 during a software upgrade on the FTP server, the password protection was accidentally removed allowing patient data to be accessed by anyone without the need for authentication.

Further, the content of the FTP server was indexed by search engines and could be found by typing in search terms contained in the notes. For example, typing in a patient’s name would allow the information to be found, which happened on at least one occasion. A patient found portions of her medical records online after performing a Google search.

The types of information exposed included names, medical diagnoses, and prescriptions of as many as 1,654 patients who had previously received medical services at one of the three medical centers.

When the privacy breach was discovered, Best Medical Transcription reinstated the password protection on the FTP server, although caches of the information remained accessible online and could still be found by performing a Google search.  The password was reinstated on January 15, 2016, although a week later, Virtua Medical Group received a call from a patient whose daughter’s medical records were still accessible online.

At that point, while Best Medical Transcription was aware of the lack of password and a potential breach, it had not notified Virtua Medical Group that data had been exposed. The investigation by Virtua Medical Group revealed 462 patients’ records had been indexed by the search engines. Virtua Medical Group submitted individual requests to Google to have the information taken down and patients were notified about the breach in March.

An investigation into the breach by the New Jersey Division of Consumer Affairs revealed there had been multiple failures to comply with Health Insurance Portability and Accountability Act (HIPAA) requirements. While the breach affected a business associate of Virtua Medical Group, it was the medical group that was penalized.

The Division of Consumer Affairs alleged there had been a failure to conduct a comprehensive risk analysis to identify threats to the confidentiality, integrity, and availability of ePHI and insufficient security protections had been implemented to reduce risk.

A security awareness and training program had not been implemented for the entire workforce, there were unacceptable delays in identifying and responding to the breach, no procedures had been established and implemented to create retrievable exact copies of the ePHI maintained on the FTP site, no written log of the number of times the FTP site was accessed had been maintained, and there had been an impermissible disclosure of patients’ ePHI.

Those errors and oversights constituted violations of the HIPAA Privacy and Security Rules and the New Jersey Consumer Fraud Act.

In addition to the financial penalty of $407,184 and $10,632 to reimburse attorney’s fees and investigation costs, Virtua Medical Group has agreed to implement a robust corrective action plan which includes hiring a third-party security professional to perform a comprehensive risk analysis relating to the storage, transmission and receipt of ePHI and to perform further risk assessments every two years.

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Patient Guidebook on Health Record Access Published by ONC

A new patient guidebook on health record access has been published by the Department of Health and Human Services’ Office of the National Coordinator for Health IT (ONC). The guidebook explains how patients can access their health data, offers tips for checking health records and correcting mistakes, and explains how patients can use their health records and share their health data.

The HIPAA Privacy Rule gave patients the right to obtain copies of health information held by their providers, yet even though the Privacy Rule became effective on April 14, 2001, many Americans are still not aware of their right to access their health data or how they can do so.

Improving patient access to health data is a top priority for the HHS and ONC. In 2016, ONC released a series of videos for patients in which their right to access their own health data was explained. The latest guidebook takes that guidance a step further and serves as a practical guide to obtaining copies of electronic heath data to make the process as easy as possible.

The ONC Guide to Getting and Using your Health Data is part of the ONC’s MyHealthEData initiative, which aims to improve patient engagement in their own healthcare and supports the 21st Century Cures Act goal of improving access to electronic health information.

“It’s important that patients and their caregivers have access to their own health information so they can make decisions about their care and treatments,” said Don Rucker, M.D., national coordinator for health information technology. “This guide will help answer some of the questions that patients may have when asking for their health information.”

While patients have the right to access their health data, many still face challenges getting access. One of the aims of the new online document is to explain how patients can overcome those challenges. One of those challenges is resistance from healthcare providers when patients request electronic copies of their health data.

By making sure patients are aware of their rights, if they encounter resistance from a provider – or health plan – they will be able to clearly explain their rights and will be empowered to overcome that resistance.

Ensuring patients can easily access their health record is only part of the problem. Many patients do not understand why they should view their health record and the importance of doing so. The guidebook helps to explain the benefits and why it is important to take a more active role in their own healthcare.

Figures recently released by ONC show that while 52% of patients have been offered access to their health records online, only half of those patients viewed their health record, equivalent to 28% of Americans.

When patients were asked why they did not view their medical record when they could do so online, 76% said they preferred to speak with their provider directly and 59% did not have a need to use their online record.

ONC’s figures show that when patients are encouraged to view their health data by their providers they are more likely to do so. 63% of patients who were encouraged to access their medical record online did so compared to just 38% who were not encouraged to check. Healthcare providers can therefore play a big part in improving patient engagement. The new guidebook will also help in that regard.

The guidebook also offers practical advice on the use of health apps and other technologies that can help patients manage their health data and improve their health.

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Legislation Changes and New HIPAA Regulations in 2018

The policy of two out for every new regulation introduced means there are likely to be few, if any, new HIPAA regulations in 2018. However, that does not mean it will be all quiet on the HIPAA front. HHS’ Office for Civil Rights (OCR) director Roger Severino has indicated there are some HIPAA changes under consideration.

OCR is planning on removing some of the outdated and labor-intensive elements of HIPAA that provide little benefit to patients, although before HIPAA changes are made, OCR will seek feedback from healthcare industry stakeholders.

As with previous updates, OCR will submit notices of proposed rulemaking and will seek comment on the proposed changes. Those comments will be carefully considered before any HIPAA changes are made.

The full list of proposed changes to the HIPAA Privacy Rule have not been made public, although Severino did provide some insight into what can be expected in 2018 at a recent HIPAA summit in Virginia.

Severino explained there were three possible changes to HIPAA regulations in 2018, the first relates to enforcement of HIPAA Rules by OCR.

Since the introduction of the Enforcement Rule, OCR has had the power to financially penalize HIPAA covered entities that are discovered to have violated HIPAA Rules or not put sufficient effort into compliance. Since the incorporation of HITECH Act into HIPAA in 2009, OCR has been permitted to retain a proportion of the settlements and CMPs it collects through its enforcement actions. Those funds are used, in part, to cover the cost of future enforcement actions and to provide restitution to victims. To date, OCR has not done the latter.

OCR is considering requesting information on how a proportion of the settlements and civil monetary penalties it collects can be directed to the victims of healthcare data breaches and HIPAA violations.

One area of bureaucracy that OCR is considering changing is the requirement for covered entities to retain signed forms from patients confirming they have received a copy of the covered entity’s notice of privacy practices. In many cases, the forms are signed by patients who just want to see a doctor. The forms are not actually read.

One potential change is to remove the requirement to obtain and store signed forms and instead to inform patients of privacy practices via a notice in a prominent place within the covered entity’s facilities.

Severino also said OCR is considering changing HIPAA regulations in 2018 relating to good faith disclosures of PHI. OCR is considering formally clarifying that disclosing PHI in certain circumstances is permitted without first obtaining consent from patients – The sharing of PHI with family members and close friends when a patient is incapacitated or in cases of opioid drug abuse for instance.

While HIPAA does permit healthcare providers to disclose PHI when a patient is in imminent harm, further rulemaking is required to cover good faith disclosures.

While these HIPAA changes are being considered, it could take until 2019 before they are implemented.

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HIPAA Rules on Contingency Planning

In its March 2018 cybersecurity newsletter, OCR explained HIPAA Rules on contingency planning and urged healthcare organizations to plan for emergencies to ensure a return to normal operations can be achieved in the shortest possible time frame.

A contingency plan is required to ensure that when disaster strikes, organizations know exactly what steps must be taken and in what order.

Contingency plans should cover all types of emergencies, such as natural disasters, fires, vandalism, system failures, cyberattacks, and ransomware incidents. The steps that must be taken for each scenario could well be different, especially in the case of cyberattacks vs. natural disasters. The plan should incorporate procedures to follow for specific types of disasters.

Contingency planning is not simply a best practice. It is a requirement of the HIPAA Security Rule. Contingency planning should not be considered a onetime checkbox item necessary for HIPAA compliance. It should be an ongoing process with plans regularly checked, updated, and tested to ensure any deficiencies are identified and addressed.

What are the HIPAA Rules on Contingency Planning?

HIPAA Rules on contingency planning are concerned with ensuring healthcare organizations return to normal operations as quickly as possible and the confidentiality, integrity, and availability of PHI is safeguarded.

HIPAA Rules on contingency planning can be found in the Security Rule administrative safeguards -45 CFR § 164.308(a)(7)(ii)(A-E).

  • Develop and Implement a Data Backup Plan – 308(a)(7)(ii)(A)
  • Develop a Disaster Recovery Plan – 308(a)(7)(ii)(B)
  • Develop and Emergency Mode Operation Plan – 308(a)(7)(ii)(C)
  • Develop and Implement Procedures for Testing and Revision of Contingency Plans – 308(a)(7)(ii)(D)
  • Perform an Application and Data Criticality Analysis – 308(a)(7)(ii)(E)

A data backup plan ensures that when disaster strikes, PHI is not lost or destroyed. A viable copy of all ePHI must be created that allows exact copies of ePHI to be restored, which includes all forms of ePHI such as medical records, diagnostic images, test results, case management information, and accounting systems.  It is a good best practice to adopt a 3-2-1 approach for backups: Create three copies of data, store them on at least two different media, and have one copy stored securely offsite. Backups must also be tested to ensure the recovery of data is possible.

A disaster recovery plan should establish the procedures that must be followed to restore access to data, including how files should be restored from backups. A copy of the plan should be readily available and stored in more than one location.

The emergency mode operation plan must ensure critical business processes continue to maintain the security of ePHI when operating in emergency mode, for example when there is a technical failure or power outage.

All elements of the contingency plan must be regularly tested and revised as necessary. OCR recommends conducting scenario-based walkthroughs and live tests of the complete plan.

Covered entities should “assess the relative criticality of specific applications and data in support of other contingency plan components.” All software applications that are used to store, maintain, or transmit ePHI must be assessed to determine the level of criticality to business functions as it will be necessary to prioritize each when data is restored.

Summary of Key Elements of Contingency Planning

OCR has provided a summary of the key elements of contingency planning:

  • The primary goal is to maintain critical operations and minimize loss.
  • Define time periods – What must be done during the first hour, day, or week?
  • Establish Plan Activation – What event(s) will cause the activation of the contingency plan?  Who has the authority to activate the contingency plan?
  • Ensure the contingency plan can be understood by all types of employees.
  • Communicate and share the plan and roles and responsibilities with the organization.
  • Establish a testing schedule for the plan to identify gaps.
  • Ensure updates for plan effectiveness and increase organizational awareness.
  • Review the plan on a regular basis and situationally when there are technical, operational, environmental, or personnel changes in the organization.

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Healthcare Data Breach Statistics

We have compiled healthcare data breach statistics from October 2009 when the Department of Health and Human Services’ Office for Civil Rights first started publishing summaries of healthcare data breaches on its website.

The healthcare data breach statistics below only include data breaches of 500 or more records as smaller breaches are not published by OCR. The breaches include closed cases and breaches still being investigated by OCR.

Our healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 9 years, with 2017 seeing more data breaches reported than any other year since records first started being published.

There have also been notable changes over the years in the main causes of breaches. The loss/theft of healthcare records and electronic protected health information dominated the breach reports between 2009 and 2015, although better policies and procedures and the use of encryption has helped reduce these easily preventable breaches. Our healthcare data breach statistics show the main causes of healthcare data breaches is now hacking/IT incidents, with unauthorized access/disclosures also commonplace.

Healthcare Data Breaches by Year

Between 2009 and 2017 there have been 2,181 healthcare data breaches involving more than 500 records. Those breaches have resulted in the theft/exposure of 176,709,305 healthcare records.  That equates to more than 50% of the population of the United States (54.25%). Healthcare data breaches are now being reported at a rate of more than one per day.

Healthcare data breaches 2019-2017

Healthcare Records Exposed by Year

While there has been a general upward trend in the number of records exposed each year, there was a massive improvement in 2017 – the best year since 2012 in terms of the number of records exposed. However, while breaches were smaller in 2017, it was a record breaking year in terms of the number of healthcare data breaches reported – 359 incidents.

Records Exposed in Healthcare data breaches

Average/Median Healthcare Data Breach Size by Year

Average Size of Healthcare Data Breaches


Median Size of Healthcare Data Breaches


Largest Healthcare Data Breaches (2009-2017)

Rank Year Entity Entity Type Records Exposed/Stolen Cause of Breach
1 2015 Anthem, Inc. Affiliated Covered Entity Health Plan 78800000 Hacking/IT Incident
2 2015 Premera Blue Cross Health Plan 11000000 Hacking/IT Incident
3 2015 Excellus Health Plan, Inc. Health Plan 10000000 Hacking/IT Incident
4 2011 Science Applications International Corporation Business Associate 4900000 Loss
5 2014 Community Health Systems Professional Services Corporation Business Associate 4500000 Theft
6 2015 University of California, Los Angeles Health Healthcare Provider 4500000 Hacking/IT Incident
7 2013 Advocate Medical Group Healthcare Provider 4029530 Theft
8 2015 Medical Informatics Engineering Business Associate 3900000 Hacking/IT Incident
9 2016 Banner Health Healthcare Provider 3620000 Hacking/IT Incident
10 2016 Newkirk Products, Inc. Business Associate 3466120 Hacking/IT Incident
11 2016 21st Century Oncology Healthcare Provider 2213597 Hacking/IT Incident
12 2014 Xerox State Healthcare, LLC Business Associate 2000000 Unauthorized Access/Disclosure
13 2011 IBM Business Associate 1900000 Unknown
14 2011 GRM Information Management Services Business Associate 1700000 Theft
15 2010 AvMed, Inc. Health Plan 1220000 Theft
16 2015 CareFirst BlueCross BlueShield Health Plan 1100000 Hacking/IT Incident
17 2014 Montana Department of Public Health & Human Services Health Plan 1062509 Hacking/IT Incident
18 2011 The Nemours Foundation Healthcare Provider 1055489 Loss
19 2010 BlueCross BlueShield of Tennessee, Inc. Health Plan 1023209 Theft
20 2011 Sutter Medical Foundation Healthcare Provider 943434 Theft

Healthcare Hacking Incidents by Year

Our healthcare data breach statistics show hacking is now the leading cause of healthcare data breaches, although healthcare organizations are now much better at detecting breaches when they do occur. The low hacking/IT incidents in the earlier years is likely to be due, in part, to the failure to detected hacking incidents and malware infections quickly. Many of the hacking incidents in 2014-2017 occurred many months, and in come cases years, before they were detected.

Healthcare Data Breaches - Hacking


Records Exposed in Healthcare Data Breaches - Hacking

Unauthorized Access/Disclosures by Year

As with hacking, healthcare organizations are getting better at detecting internal breaches and also reporting those breaches to the Office for Civil Rights. While hacking is the main cause of breaches, unauthorized access/disclosure incidents are in close second.

Healthcare Data Breaches - unauthorized access/disclosures


records exposed in authorized access/disclosures

Loss/Theft of PHI and Unencrypted ePHI by Year

Our healthcare data breach statistics show HIPAA covered entities and business associates have got significantly better at protecting healthcare records with administrative, physical, and technical controls such as encryption, although unencrypted laptops and other electronic devices are still being left unsecured in vehicles and locations accessible by the public.

healthcare theft/loss data breaches


records exposed by healthcare theft/loss data breaches

Improper Disposal of PHI/ePHI by Year

healthcare data breaches - improper disposal incidents


records exposed in healthcare improper disposal incidents


Breaches by Entity Type

Year Provider Health Plan Business Associate Other Total
2009 14 1 3 0 18
2010 134 21 44 0 199
2011 137 20 42 1 200
2012 155 22 36 4 217
2013 199 18 56 5 278
2014 202 71 41 0 314
2015 196 62 11 0 269
2016 257 51 19 0 327
2017 288 52 19 0 359
Total 1582 318 271 10 2181

OCR Settlements and Fines for HIPAA Violations

The penalties for HIPAA violations can be severe with multi-million-dollar fines possible when violations have been allowed to persist for several years or when multiple violations of HIPAA Rules have been allowed to occur.

The penalty structure for HIPAA violations is detailed in the infographic below:

Penalty Structure for HIPAA Violations

OCR Settlements and Fines Over the Years

The data for the healthcare data breach statistics on fines and settlements can be viewed on our HIPAA violation fines page, which details all HIPAA violation fines issued by OCR between 2008 and 2018. As the graph below shows, there has been a steady increase in HIPAA enforcement over the past 9 years.

HIPAA Fines and Settlements 2008-2017


How Much Has OCR Fined HIPAA Covered Entities and Business Associates?

In addition to an increase in fines and settlements, the level of fines has increased substantially. Multi-million-dollar fines for HIPAA violations are now the norm.

HIPAA Fine and Settlement Amounts 2008-2017


average HIPAA Fines and Settlements 2008-2017


Median HIPAA Fines and Settlements 2008-2017

As the graphs above show, there has been a sizable increase in both the number of settlements and civil monetary penalties and the fine amounts in recent years. OCR’s budget has been cut so there are fewer resources to put into pursuing financial penalties in HIPAA violation cases. 2018 is likely to see fewer fines for HIPAA covered entities than the past two years, although settlement amounts are likely to remain high and even increase in 2018.OCR Director Roger Severino has indicated financial penalties are most likely to be pursued for particularly egregious HIPAA violations.

State Attorneys General HIPAA Fines and Other Financial Penalties for Healthcare Organizations

State attorneys general can issue fines ranging from $100 per HIPAA violation up to a maximum of $25,000 per violation category, per year.

Even when action is taken by state attorneys general over potential HIPAA violations, healthcare organizations are typically fined for violations of state laws. Only a handful of U.S. states have issued fines solely for HIPAA violations

Some of the major fines issued by state attorneys general for HIPAA violations and violations of state laws are listed below.


Year State Covered Entity Amount Individuals affected Settlement/CMP Reason
2018 NY EmblemHealth $575,000 81,122 Settlement Mailing error
2018 NY Aetna $1,150,000 12,000 Settlement Mailing error
2017 CA Cottage Health System $2,000,000 More than 54,000 Settlement Failure to adequately protect medical records
2017 MA Multi-State Billing Services $100,000 2,600 Settlement Theft of unencrypted laptop containing PHI
2017 NJ Horizon Healthcare Services Inc., $1,100,000 3.7 million Settlement Loss of unencrypted laptop computers
2017 VT SAManage USA, Inc. $264,000 660 Settlement Spreadsheet indexed by search engines and PHI viewable
2017 NY CoPilot Provider Support Services, Inc $130,000 221,178 Settlement Delayed breach notification
2015 NY University of Rochester Medical Center $15,000 3,403 Settlement List of patients provided to nurse who took it to a new employer
2015 CT Hartford Hospital/ EMC Corporation $90,000 8,883 Settlement Theft of unencrypted laptop containing PHI
2014 MA Women & Infants Hospital of Rhode Island $150,000 12,000 Settlement Loss of backup tapes containing PHI
2014 MA Boston Children’s Hospital $40,000 2,159 Settlement Loss of laptop containing PHI
2014 MA Beth Israel Deaconess Medical Center $100,000 3,796 Settlement Loss of laptop containing PHI
2013 MA Goldthwait Associates $140,000 67,000 Settlement Improper disposal
2012 MN Accretive Health $2,500,000 24,000 Settlement Mishandling of PHI
2012 MA South Shore Hospital $750,000 800,000 Settlement Loss of backup tapes containing PHI
2011 VT Health Net Inc. $55,000 1,500,000 Settlement Loss of unencrypted hard drive/delayed breach notifications
2011 IN WellPoint Inc. $100,000 32,000 Settlement Failure to report breach in a reasonable timeframe
2010 CT Health Net Inc. $250,000 1,500,000 Settlement Loss of unencrypted hard drive/delayed breach notifications

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2018 HIPAA Changes and Enforcement Outlook

Are there likely to be major 2018 HIPAA changes? What does this year have in store in terms of new HIPAA regulations? OCR Director Roger Severino has hinted there could be some 2018 HIPAA changes and that HIPAA enforcement in 2018 is unlikely to slowdown.

Are Major 2018 HIPAA Changes Likely?

The Trump administration has made it clear that there should be a decrease rather than an increase in regulation in the United States. In January 2017, Trump signed an executive order calling for a reduction in regulation, which was seen to be hampering America’s economic growth. At the time Trump said, “If there’s a new regulation, they have to knock out two. But it goes far beyond that, we’re cutting regulations massively for small business and for large business.”

While Trump was not specifically referring to healthcare, it is clear we are currently in a period of deregulation. Trump’s words were recently echoed by Severino at the HIMSS conference who confirmed the HSS understands deregulation in some areas is required before further regulations can be introduced.

Therefore, there are unlikely to be major 2018 HIPAA changes, at lease not in terms of increased regulation. What is more likely is an easing of the administrative burden on healthcare organizations in 2018.

OCR is currently reviewing existing HIPAA regulations to determine whether all aspects of HIPAA Rules are still relevant and if there are any areas where the administrative burden on healthcare organizations can be eased. OCR is looking at the benefit of various provisions of HIPAA and whether those benefits outweigh the costs.

The HHS has said its goals are “reducing the burden of compliance” and “streamlining its regulations,” while promoting “meaningful information sharing”.

2018 HIPAA changes could make life simpler for many healthcare organizations as the HHS attempts to minimize duplication and burdensome requirements and eliminate outdated restrictions and obsolete regulations.

HIPAA Enforcement in 2018

In 2016 there was a significant increase in HIPAA enforcement activities by OCR with more settlements reached with covered entities and business associates than any other year since the HIPAA Enforcement Rule was signed into law. In 2016 there were 12 settlements and one civil monetary penalty issued and 2017 HIPAA settlements were well above average levels, with 9 settlements and one civil monetary penalty. So, what can we expect for HIPAA enforcement in 2018?

At HIMSS 2018, Roger Severino gave a presentation on HIPAA compliance, enforcement, and policy updates from the Office for Civil Rights and made it clear OCR will continue to pursue settlements with HIPAA covered entities for egregious violations of HIPAA Rules. Severino said OCR still has the same enforcement mindset and that there will be “no slowdown in our enforcement efforts,” and “we’re still looking for big, juicy, egregious cases.” That does not necessarily mean large healthcare organizations. OCR treats potential HIPAA violations on a case by case basis, and smaller healthcare organizations may similarly be punished if they are discovered to have violated HIPAA Rules.

Severino said OCR does not want to fine healthcare organizations for violating HIPAA Rules and wants the settlements to reduce, but for that to happen, healthcare organizations must improve their compliance programs. 2018 HIPAA enforcement is likely to continue to see financial penalties issued for common HIPAA violations such as the failure to conduct regular risk assessments.  Already, 2018 has seen two settlements announced. A $100,000 penalty for Filefax, Inc., and a $3,500,000 settlement with Fresenius Medical Care North America. Time will tell if this was a blip or if that pace will be maintained throughout the year.

OCR is not the only enforcer of HIPAA Rules. State attorneys general can also issue fines for HIPAA violations, and the New York AG has been active in this area in recent weeks, fining EmblemHealth $575,000 in March and Aetna $1,150,000 in January. Further financial settlements are likely to be pursued in NY and other states to resolve HIPAA violations and privacy and security-related breaches of state laws.

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HIPAA Social Media Rules

HIPAA was enacted several years before social media networks such as Facebook were launched, so there are no specific HIPAA social media rules; however, there are HIPAA laws and standards that apply to social media use by healthcare organizations and their employees. Healthcare organizations must therefore implement a HIPAA social media policy to reduce the risk of privacy violations.

There are many benefits to be gained from using social media. Social media channels allow healthcare organizations to interact with patients and get them more involved in their own healthcare. Healthcare organizations can quickly and easily communicate important messages or provide information about new services. Healthcare providers can attract new patients via social media websites. However, there is also considerable potential for HIPAA Rules and patient privacy to be violated on social media networks. So how can healthcare organizations and their employees use social media without violating HIPAA Rules?

HIPAA and Social Media

The first rule of using social media in healthcare is to never disclose protected health information on social media channels. The second rule is to never disclose protected health information on social media. (see the definition of protected health information for further information).

The HIPAA Privacy Rule prohibits the use of PHI on social media networks. That includes any text about specific patients as well as images or videos that could result in a patient being identified. PHI can only be included in social media posts if a patient has given their consent, in writing, to allow their PHI to be used and then only for the purpose specifically mentioned in the consent form.

Social media channels can be used for posting health tips, details of events, new medical research, bios of staff, and for marketing messages, provided no PHI is included in the posts.

Employees Must be Trained on HIPAA Social Media Rules

In 2017, 71% of all Internet users visited social media websites. The popularity of social media networks combined with the ease of sharing information means HIPAA training should include the use of social media. If employees are not specifically trained on HIPAA social media rules it is highly likely that violations will occur.

Training on HIPAA should be provided before an employee starts working for the company or as soon as is possible following appointment. Refresher training should also be provided at least once a year to ensure HIPAA social media rules are not forgotten.

HIPAA Violations on Social Media

In 2015, ProPublica published the results of an investigation into HIPAA social media violations by nurses and care home workers. The investigation primarily centered on photographs and videos of patients in compromising positions and patients being abused.

In some cases, images and videos were widely shared, in others photographs and videos were shared in private groups. ProPublica uncovered 47 HIPAA violations on social media since 2012, although there were undoubtedly many more that were not discovered and were never reported.

In most cases, the HIPAA violations on social media resulted in disciplinary action against the employees concerned, there were several terminations for violations of patient privacy, and in some cases, the violations resulted in criminal charges. A nursing assistant who shared a video of a patient in underwear on Snapchat was fired and served 30 days in jail.

It is not only employees that can be punished for violating HIPAA Rules. There are also severe penalties for HIPAA violations for healthcare providers.

Common Social Media HIPAA Violations

  • Posting of images and videos of patients without written consent
  • Posting of gossip about patients
  • Posting of any information that could allow an individual to be identified
  • Sharing of photographs or images taken inside a healthcare facility in which patients or PHI are visible
  • Sharing of photos, videos, or text on social media platforms within a private group

HIPAA Social Media Guidelines

Listed below are some basic HIPAA social media guidelines to follow in your organization, together with links to further information to help ensure compliance with HIPAA Rules.

  • Develop clear policies covering social media use and ensure all employees are aware of how HIPAA relates to social media platforms
  • Train all staff on acceptable social media use as part of HIPAA training and conduct refresher training sessions annually
  • Provide examples to staff on what is acceptable – and what is not – to improve understanding
  • Communicate the possible penalties for social media HIPAA violations – termination, loss of license, and criminal penalties
  • Ensure all new uses of social media sites are approved by your compliance department
  • Review and update your policies on social media annually
  • Develop policies and procedures on use of social media for marketing, including standardizing how marketing takes place on social media accounts
  • Develop a policy that requires personal and corporate accounts to be totally separated
  • Create a policy that requires all social media posts to be approved by your legal or compliance department prior to posting
  • Monitor your organization’s social media accounts and communications and implement controls that can flag potential HIPAA violations
  • Maintain a record of social media posts using your organization’s official accounts that preserves posts, edits, and the format of social media messages
  • Do not enter into social media discussions with patients who have disclosed PHI on social media.
  • Encourage staff to report any potential HIPAA violations
  • Ensure social media accounts are included in your organization’s risk assessments
  • Ensure appropriate access controls are in place to prevent unauthorized use of corporate social media accounts
  • Moderate all comments on social media platforms

The Department of Health and Human Services’ Office for Civil Rights has issued guidance on HIPAA social media regulations, detailing the specific aspects of HIPAA that apply to social media networks. A HIPAA compliance checklist for social media can be viewed on the HHS website.

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