HIPAA News

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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Alabama Data Breach Notification Act Passed by State Senate

The Alabama Data Breach Notification Act (Senate Bill 318) has advanced for consideration by the House of Representatives after being unanimously passed by the Alabama Senate last week.

Alabama is one of two states that has yet to introduce legislation that requires companies to issue notifications to individuals whose personal information is exposed in data breaches. The other state – South Dakota – is also considering introducing similar legislation to protect state residents.

The Alabama Data Breach Notification Act, proposed by Sen. Arthur Orr (R-Decatur), requires companies doing business in the state of Alabama to issue notifications to state residents when their sensitive personal information has been exposed and it is reasonably likely to result in breach victims coming to substantial harm.

Entities that would be required to comply with the Alabama Data Breach Notification Act are persons,

sole proprietorships, partnerships, government entities, corporations, non-profits, trusts, estates, cooperative associations, and other business entities that acquire or use sensitive personally identifying information.

Sensitive personally identifying information is defined as a first name/first initial and last name combined with any of the following data elements, provided they are not truncated, encrypted, or hashed:

  • Social Security number
  • Tax ID number
  • Driver’s license number
  • State identification card number
  • Military identification number
  • Passport number
  • Other unique government identification number
  • Medical information such as health history, treatment or diagnosis or mental/physical condition
  • Health insurance number or unique identifiers used by health insurers for identification of an individual
  • Financial account number (bank account, credit card, or debit card) combined with an expiry date, security code, PIN, password, or other information that would allow a financial transaction to be conducted
  • Username or email address along with a password or security question answer that would allow an account to be accessed

The Alabama Data Breach Notification Act also calls for entities holding the above information to implement and maintain reasonable security measures to protect sensitive personally identifiable information. A risk analysis must be conducted to identity potential security risks and safeguards would need to be adopted reduce those risks to a reasonable level. Measures to protect data should be appropriate for the sensitivity of the data, the amount of data held, the size of the organization, and the cost of safeguards relative to the company’s resources.

If the Alabama Data Breach Notification Act is passed, state residents would have to be notified of data breaches within 45 days of discovery of a breach. Companies that fail to issue the notifications could potentially be fined up to $5,000 per day for any delay in issuing notifications up to a maximum of $500,000 per breach. Lawsuits could be filed by the attorney general’s office on behalf of breach victims, although private actions would not be possible.

Breach notices would be required to include the date or estimated date of the breach, a description of the information exposed, details of the steps that can be taken by breach victims to protect themselves against harm, details of the steps taken by the breached entity to restore security and confidentiality of data, and contact information for further information about the breach. A breach notice would also need to be submitted to the state attorney general’s office if the breach impacts more than 1,000 individuals.

In contrast to data breach notification laws in some US states that exempt HIPAA covered entities that are in compliance with HIPAA laws, the Alabama Data Breach Notification Act would apply to HIPAA covered entities.

The current maximum time frame for HIPAA covered entities is 60 days from the date of discovery of a breach. For Alabama residents at least, that time frame would be reduced by 15 days.

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EmblemHealth Fined $575,000 by NY Attorney General for HIPAA Breach

A 2016 mailing error by EmblemHealth that saw the Health Insurance Claim Numbers of 81,122 plan members printed on the outside of envelopes has resulted in a $575,000 settlement with the New York Attorney General.

While all mailings include a unique patient identifier on the envelope, in this case the potential for harm was considerable as Health Insurance Claim numbers are formed using the Social Security numbers of plan members.

Announcing the settlement, New York Attorney General Eric T. Schneiderman explained that Health Insurance Portability and Accountability Act (HIPAA) Rules require HIPAA covered entities to implement administrative, physical, and technical safeguards to ensure the confidentiality of patients’ and plan members’ protected health information.

The error that saw Social Security numbers exposed violated HIPAA Rules. EmblemHealth failed to comply with “many standards and procedural specifications” required by HIPAA. Attorney General Schneiderman also said that printing Social Security numbers on the outside of envelopes violated New York General Business Law § 399-ddd(2)(e).

In addition to the $575,000 settlement, EmblemHealth is required to adopt a robust corrective action plan that requires a comprehensive risk analysis to be conducted related to the mailing of policy documents. The results of that risk analysis must be reported to the Attorney General’s office within 180 days. Policies and procedures related to mailings must also be reviewed and updated based on the findings of the risk analysis.

EmblemHealth must catalogue, review, and monitor mailings and ensure that all employees involved in mailings receive appropriate training. They must also be instructed to report any violations of the HIPAA Minimum Necessary Standard to EmblemHealth officials to allow prompt action to be taken manage risks to plan members. EmblemHealth is also required to report all security incidents to the Attorney General’s office for a period of 3 years from the date of the settlement.

According to Attorney General Schneiderman, New York has “weak and outdated security laws” which he has attempted to address by introducing the ‘Stop Hacks and Improve Electronic Data Security (SHIELD) Act’ in November 2017. There will now be a further push to get the SHIELD Act passed. Schneiderman claims the SHIELD Act will improve protections for state residents. Businesses will also be held accountable for data breaches that result in customers’ personal data being exposed.

“The careless handling of social security numbers is never acceptable,” said Attorney General Schneiderman. “New Yorkers need to be able to trust that companies entrusted with their private information will guard it appropriately. This starts with good governance—which is why my office will continue to push for stronger security laws and hold businesses accountable for protecting their customers’ personal data.”

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Updated Colorado Data Breach Notification Advances: Reporting Period Cut to 30 Days

In January, a new data breach notification bill was introduced in Colorado that proposed updates to state laws to improve protections for residents affected by data breaches. The bill introduced a maximum time frame of 45 days for companies to notify individuals whose personal information was exposed or stolen as a result of a data breach. The definition of personal information was also updated to include a much wider range of information including data covered by HIPAA – medical information, health insurance information, and biometric data.

Last week, Colorado’s House Committee on State, Veterans, and Military Affairs unanimously passed an updated version of the bill, which has now been passed to the Committee on Appropriations for consideration.

The updated bill includes further new additions to the list of data elements classed as personal information – passport numbers, military, and student IDs. There has also been a shortening of the time frame organizations have to issue notifications. Instead of the 45 days proposed in the original bill, the time frame has been cut to just 30 days following the date of determination that a security breach has occurred.

Typically, when states propose legislation to improve protections for state residents whose personal information is exposed, organizations in compliance with federal data breach notification laws are deemed to be in compliance with state laws.

However, the new bill clarifies that will not necessarily be the case. Healthcare organizations covered by HIPAA laws have up to 60 days to issue notifications to breach victims. The amended bill states that when federal laws require notifications to be sent, the breached entity will be required to comply with the law with the shortest time frame for issuing notices.

That means HIPAA covered entities who experience a data breach that impacts Colorado residents would have half as long to issue notifications.

The original bill required breached entities to issue notifications to the state attorney general within 7 days of the discovery of a breach impacting 500 or more Colorado residents. The amended bill has seen that requirement relaxed to 30 days following the discovery of a breach of personal information. Further, the state attorney general does not need to be notified of a breach if there has been no misuse of breached data or if data misuse is unlikely to occur in the future.

If the new legislation is passed, Colorado residents will be among the best protected individuals in the United States. Only Florida has introduced such strict time scales for sending notifications to breach victims. Colorado residents would also be much better protected when their data is exposed by a healthcare organization, with the time frame for notification cut in half.

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$100,000 Settlement Shows HIPAA Obligations Don’t End When a Business Closes

HIPAA covered entities and their business associates must abide by HIPAA Rules, yet when businesses closes the HIPAA obligations do not end. The HHS’ Office for Civil Rights (OCR) has made this clear with a $100,000 penalty for FileFax Inc., for violations that occurred after the business had ceased trading.

FileFax is a Northbrook, IL-based firm that offers medical record storage, maintenance, and delivery services for HIPAA covered entities. The firm ceased trading during the course of OCRs investigation into potential HIPAA violations.

An investigation was launched following an anonymous tip – received on February 10, 2015 – about an individual that had taken documents containing protected health information to a recycling facility and sold the paperwork.

That individual was a “dumpster diver”, not an employee of FileFax. OCR determined that the woman had taken files to the recycling facility on February 6 and 9 and sold the paperwork to the recycling firm for cash. The paperwork, which included patients’ medical records, was left unsecured at the recycling facility. In total, the records of 2,150 patients were included in the paperwork.

OCR determined that between January 28, 2015 and February 14, 2015, FileFax had impermissibly disclosed the PHI of 2,150 patients as a result of either: A) Leaving the records in an unlocked truck where they could be accessed by individuals unauthorized to view the information or; B) By granting permission to an individual to remove the PHI and leaving the unsecured paperwork outside its facility for the woman to collect.

Since FileFax is no longer in business – the firm was involuntarily dissolved by the Illinois Secretary of State on August 11, 2017 – the HIPAA penalty will be covered by the court appointed receiver, who liquidated the assets of FileFax and is holding the proceeds of that liquidation.

A corrective action plan has also been issued that requires the receiver to catalogue all remaining medical records and ensure the records are stored securely for the remainder of the retention period. Once that time period has elapsed, the receiver must ensure the records are securely and permanently destroyed in accordance with HIPAA Rules.

The settlement has been agreed with no admission of liability.

HIPAA Retention Requirements and Disposal of PHI

There are no HIPAA retention requirements – Covered entities and their business associates are not required to keep medical records after their business has ceased trading. However, that does not mean medical records and PHI can be disposed of immediately. Businesses are bound by state laws, which do require documents to be retained for a set period of time. For instance, in Florida, physicians must maintain medical records for 5 years after the last patient contact and in North Carolina hospitals must maintain records for 11 years following the last date of discharge.

During that time, HIPAA requires appropriate administrative, technical, and physical safeguards to be implemented to ensure those records are secure and remain confidential. After the retention period is over, all PHI must be disposed of in a compliant manner.

In the case of paper records, disposal typically means shredding, burning, pulping, or pulverization. Whatever method chosen must render the documents indecipherable and incapable of reconstruction.

This HIPAA breach is similar to several others that have occurred over the past few years. Businesses have ceased trading and paper records containing the protected health information of patients have been dumped, abandoned, or left unsecured. There have also been cases where businesses have moved location and left paperwork behind, only for contractors performing a cleanup or refurb of the property to find the paperwork and dispose of it with regular trash.

The failure to secure PHI during the retention period and the incorrect disposal of records after that retention period is over are violations of HIPAA Rules that can attract a significant financial penalty.

“The careless handling of PHI is never acceptable,” said OCR Director Roger Severino in a press release about the latest HIPAA settlement. “Covered entities and business associates need to be aware that OCR is committed to enforcing HIPAA regardless of whether a covered entity is opening its doors or closing them. HIPAA still applies.”

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