At the start of each new year, it is always good to look back at federal settlements under the Health Insurance Portability and Accountability Act (HIPAA). That is how you know matters most to the Feds in terms of privacy enforcement.
From 2017, here is a short list of key messages:
Now let’s take these one by one, with examples illustrating each point.
Understanding HIPAA requirements:
In a case involving CardioNet, a provider of remote mobile monitoring of heart patients, the Feds said that a lack of understanding of HIPAA creates risk. CardioNet paid the cost of such ignorance in a $2.5 million settlement, stemming from a laptop stolen from an employee’s vehicle, and containing private health information. Read the Press Release.
In April, the Feds put out a news alert with the headline, No Business Associate Agreement? $31K Mistake.
It’s was as if to say “Gotcha” -- albeit in a small settlement by HIPAA standards. The case involved a children’s digestive health center. As the Feds were investigating one of the center’s Business Associates, they discovered the absence of a Business Associate agreement, which was the health center’s responsibility to execute. Read the Resolution Agreement and Corrective Action Plan - PDF.
In a case involving unauthorized access to health information, Memorial Healthcare System (MHS) paid the Feds $5.5 million to settle potential violations. Private health information had been impermissibly accessed and disclosed through login credentials of a former employee of an affiliated physician’s office. For a year’s time, the unauthorized access took place on a daily basis -- and without detection due to a failure to monitor of database activity. Read the Resolution Agreement.
A case involving Children’s Medical Center of Dallas (Children’s) stemmed from impermissible disclosure of unsecured, electronic health information and non-compliance with HIPAA standards over many years, according to the Feds. The Feds issued a notice to Children’s, which included instructions for how Children’s could file a request for a hearing. Children’s did not request a hearing. Children’s paid a civil penalty of $3.2 million, and the Feds called out the issue of timely response. Read the Press Release.
This is essential to HIPAA compliance. In a case resulting in a $2.3 million settlement, the Federal Bureau of Investigation (FBI) notified 21st Century Oncology, Inc. (21CO)
on two separate occasions that patient information was illegally obtained by an unauthorized third party. Evidence included 21CO patient files purchased by an FBI informant. Among other things, the Feds determined that 21CO failed to implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports. Read the News Release.
The vast majority of HIPAA cases are resolved through corrective action plans that the Feds monitor. While that means no fine, you'll still have the Feds hovering over you for a while.
A Business Associate is a person or organization, other than an employee of a covered entity, who performs functions or provides services related to creating, receiving, maintaining, or transmitting Protected Health Information (PHI) on behalf of your organization.
Remember!: With all of your business associates, you need an agreement that legally binds you (the HIPAA covered entity) and the business associate with very clear terms for managing and protecting health information emanating from you.
A written contract with your Business Associate must:
Detail the uses and disclosures of PHI the Business Associate may make
Require that the Business Associate safeguard PHI
In other words, if any one person or vendor has potential access to private health information, you need to hold them accountable to the same high standards as you are held accountable.
By now, you know that international ransomware attackers have hit health systems in the United States. While it’s up to the techs within your organization to apply security measures, it’s everyone’s job to thwart thieves by recognizing and avoiding their traps - often hidden in seemingly harmless emails.
Keep in mind that hackers are smart, and it’s their business to fool even the most conscientious employees in close proximity to patient information. That’s why it’s important to know the warning signs of ransomware.
Let’s start with some basics pertaining to email:
Of course the goal is to avoid the schemes of hackers, who typically “kidnap” information with the promise of releasing it back to its rightful owner in exchange for money. A joint study conducted by several security firms estimates that creators of one form of ransomware -- called CryptoWall 3.0 - have extracted more than $325 million from victims since January 2015.
In the event you fall victim to a ransomware scheme, you should know the tell-tale signs of being hacked so that you can seek help right away. One common scenario is that you click on a link or open an attachment and immediately realize it is suspicious. Get help, even if you’re not 100 percent sure it’s a problem.
Other indicators of a ransomware include:
If you do not need remote access to a database containing patient information, disable the service on your computer. If you do need remote access, use it only as necessary. And make sure your password is next to impossible to figure out. By now you may wonder what the odds are that you may encounter a ransomware threat. Well, a recent U.S. Government interagency report indicates that, on average, there have been 4,000 daily ransomware attacks since early 2016. That’s a 300% increase over the 1,000 daily ransomware attacks reported in 2015!
That is why everyone needs to have an eagle eye out for the crooks.
Here are just a few other things to keep in mind:
Simple safety practices on the part of all can thwart thieves so the can’t do their dirty work. That’s the goal -- and it takes a community of dedicated workers to achieve it.
Note: Information included in this post has been compiled from email alerts distributed by the U.S. Office for Civil Rights (OCR) from May 12 through May 16, in response to interational threats impacting healthcare. Reference material includes: February 2, 2016, and March 30, 2016 cyber awareness updates, and a February 2017 newsletter, all from OCR, and a Ransomware Fact Sheet from the U. S. Department of Health and Human Services.
With the onset of federally mandated enforcement of patient privacy laws, it’s a good time to review lessons from HIPAA cases announced in 2016. Common themes clearly prevail.
In reviewing these lessons, keep in mind that the feds continue to clarify the stricter rules in place since 2013 under the Health Information Portability and Accountability Act (HIPAA). Since federal audits began only last year, gray areas continue to muddle the murky waters.
Here are some overriding messages from recent federal cases and news releases:
Make this a top priority, and include all remote facilities in your assessment. Also account for the security of mobile devices and databases in the homes and cars of employees, including telecommuters. Multiple settlements drive home this point. Also remember that you need proper policies and procedures in place as part of risk analysis and mitigation.
Example: The case of St. Joseph Health (SJH), which operates hospitals, home health agencies, hospice care, outpatient services, skilled nursing facilities, community clinics and physician organizations in California, Texas and New Mexico. SJH agreed to pay $2.14 million in a settlement with the U.S. Office for Civil Rights (OCR), relating to a report that files containing electronic protected health information (ePHI) became publicly accessible through internet search engines from 2011 until 2012. A server SJH purchased included a file sharing application, and the default setting allowed anyone with an internet connection to access the data, potentially breaching the privacy of nearly 32,000 patients.
The feds said: Although SJH hired a number of contractors to assess risks and vulnerabilities, evidence indicated a “patchwork” approach falling short of “enterprise-wide risk analysis.”
Again, multiple cases reinforce this as a big priority. The point is that if any outside person or vendor can potentially access private information about your patients, then you need to hold those vendors or individuals to the same rules that apply to you. You need formal agreements with them. Also know that HIPAA audits extend to business associates.
Example: The Archdiocese of Philadelphia agreed to pay $650,000 to settle potential privacy violations relating to the theft of a mobile device containing protected health information for 412 nursing home residents. In this case, Catholic Health Care Services (CHCS), an agency of the Diocese, performed IT services as a business associate to six skilled nursing facilities. The potential breach happened as a result of a theft of a CHCS-issued employee iPhone, which was unencrypted and not password protected. The information on the iPhone included social security numbers, information about diagnoses, medications and treatments, and names of family members and legal guardians.
The feds said: CHCS had no policies addressing the removal of mobile devices containing patient information from its facility, and no risk analysis or risk management plan.
Click here to read more about what happened.
You’re on hook, too. HIPAA-covered providers of all types and sizes are subject to audits. Last fall, OCR announced it is now working with its regional offices to “more widely investigate the root causes of breaches affecting fewer than 500 individuals.” The regional offices will still have discretion on which smaller breaches to investigate, but each office will increase its efforts to address these smaller breaches.
In a recent newsletter, OCR discussed the “insider threat” as one of the largest threats to the security of patient information within organizations. The agency noted that even some cyberattacks may be insider-driven.
According to a recent survey, conducted by Accenture and HfS Research, 69% of organizations surveyed reported experiences with malicious activity on the part of insiders, including current or former employees, contractors and business associates.
Keep in mind, whenever patient information reaches unauthorized ears and eyes, nothing stops it from getting on social media. And yes, that does happen, especially among patients who are most vulnerable and unsuspecting.
Click here for more about how to guard against insider threats, and recommendations for preventing abuses.
The feds have released a new fact sheet that explains how HIPAA Rules permit disclosures of Protected Health Information (PHI) to support public health activities conducted by public health agencies, as authorized by state or federal law. The facc sheet offers examples of instances where the sharing PHI supports public health policies.
You may find the new fact sheet on the federal government's website at: https://www.healthit.gov/
Thank you to all who attended the HIPAA compliance session last week in Columbus at the fall conference of the Ohio Provider Resource Association (OPRA). For the benefit of those who requested a copy for our Compliance Charter Template, the attachment is below in a Word document. The presentation is attached as well. Diane Evans, Publisher, MyHIPAA Guide
If you haven't already, read the CMS memo to state survey agencies, ordering a crackdown on social media abuses. Policies aren't enough, the memo says. You also need ongoing, sustainable compliance plans.
By Diane Evans
Publisher, MyHIPAA Guide
If we “fact check” presidential candidates, why not also fact check Medicare? After all, Medicare’s newly announced physician-reimbursement plan will affect the health care coverage of more than 55 million Americans and will determine the kind of treatments that Medicare beneficiaries receive.
If you are enrolled in Medicare, this new paradigm means your particular treatment may be determined by statistics, presumably showing what has worked best for others like you. Of course, the success of such a data-driven approach depends on the quality of the data.
So, the very first question is: In moving away from fee-for-service payments to doctors in favor of so-called “value-based care,” will Americans benefit as Medicare promises? Let’s start fact checking!
In an open letter accompanying last week’s announcement, acting Medicare chief Andy Slavitt describes the government’s new approach as a “more modern, patient-centered program. . . promoting quality patient care while controlling escalating costs.’’ He further notes that by healthcare providers working cooperatively with Medicare, “we can all make real progress in improving the delivery of care in our country.”
In fact: The new system will award higher pay to doctors who base their medical decisions on “best practices” determined by statistics. However, health IT experts—including some in the federal government—warn that the technology simply isn’t available yet to do the high-quality data analysis necessary to standardize patient treatment plans. By the government’s own estimate in a report titled “Capturing High-Quality Electronic Health Records (EHR) Data to Support Performance Improvement,” the nation won’t have the advanced technology for such comprehensive data analysis until 2024.
In an Executive Summary explaining the new system, Medicare says that doctors can qualify for higher pay based in part on dispensing patient care according to models developed private insurers or Medicaid programs. This is presented as a means of achieving higher quality care.
In fact: In a 2011 study, McKinsey & Company refers to transparency as a key precondition to improved healthcare delivery. Yet commercial entities (such as big insurers) don’t readily reveal data for the sake of transparent analysis of best health care treatments. Says McKinsey: “Even in the United States, where health care data is abundant, political and commercial considerations have hindered attempts to use public reporting to drive outcome improvements.”
In addition, the government’s own report, “Capturing High Quality” (referenced above), points to the risks of deciding care based on unsubstantiated data. In one example, the report points to a federally funded project in Rhode Island that set out to improve the health of diabetes patients. However, researchers discovered data quality issues due to missing or inaccessible data or wide, inexplicable variations in outcomes.
The Capturing High Quality report concludes that “as the industry moves toward value-based reimbursement — reimbursement based on quality and cost measures — improving the quality of the data used for measurement is imperative.”
In his letter, Andy Slavitt explains plans for an information superhighway in healthcare, saying the focus is on “measures that support hospitals and physicians safely and securely exchanging information.”
In fact: Earlier this month, the federal agency responsible for healthcare technology hosted a webinar to address what the agency called the “important safety topic” of EHR usability. The webinar featured Dr. Andrew Gettinger, Executive Director of the federal Office of Clinical Quality and Safety, and leaders of the Pew Charitable Trusts, which has studied EHR usability. The issues covered in the webinar are summed up on Pew’s website and include this warning:
“Although the United States has invested tens of billions of dollars to encourage providers to adopt electronic health records, many clinicians have found that these systems have poor ‘usability.’ EHRs can put patients at risk of medical error, do little to enhance clinical care, and increase the time clinicians spend documenting patient care. Indeed, one study found that 15 percent of physicians reported that their EHR had caused a potential medication error within the past month.”
Other evidence supports Pew’s findings. Examples include:
In the case of Medicare, the point of this exercise goes beyond half-truths and pertinent omissions. The issue here is one of medical ethics. If America lacks the technology for standardized patient care based on statistical analysis, then premature demands to move in this direction put the very health of Americans at unnecessary risk. Like the project in Rhode Island, the statistics used to determine patient treatments may be flawed. And yet doctors stand to make more money by playing along – dispensing care according to statistical outcomes that may or may not be valid. All the while, those physicians who buck the system face financial penalties.
In his letter last week, Andy Slavitt extols Medicare for “becoming more open, transparent and responsive (and) committed to paying close attention to the impact of our policies on care delivery.”
Really? Mr. Slavitt, please look Americans in the eye and explain.
By Diane Evans
Publisher, MyHIPAA Guide
In a great paradox of 21st Century medicine, none other than Medicare is a violator of the timeless standard of medical ethics expressed in the Hippocratic rule: First do no harm.
The worst part? It’s that bonuses paid to physicians, from Medicare and Medicaid, are tied to activities that may actually harm some patients.
The issue relates to Electronic Health Records (EHRs). No question, electronic data holds the potential to greatly improve patient treatments based on proven results. However, it is also true that bad data can result in deadly mistakes. And therein lies the problem.
Currently, Medicare is pushing doctors to enter data and make medical decisions based on statistical analysis. Yet at the same time, health IT experts -- including some in the federal government -- are warning of hazards caused by shortcomings in EHR technology. The technology simply isn’t available yet to do the high-quality data analysis that Medicare is demanding prematurely.
Earlier this month, the federal agency responsible for healthcare technology hosted a webinar to address what the agency called “this important safety topic” of EHR usability. The webinar featured Dr. Andrew Gettinger, Executive Director of the federal Office of Clinical Quality and Safety, and Drs. Peter Provonost and Josh Rising from the Pew Charitable Trusts. The issues covered in the webinar are summed up on Pew’s website and include this warning:
“Although the United States has invested tens of billions of dollars to encourage providers to adopt electronic health records (EHRs), many clinicians have found that these systems have poor ‘usability.’ EHRs can put patients at risk of medical error, do little to enhance clinical care, and increase the time clinicians spend documenting patient care. Indeed, one study found that 15 percent of physicians reported that their EHR had caused a potential medication error within the past month.”
Fifteen percent within a month? That raises a huge question of how many people are being harmed - right now, today -- without anybody knowing about it.
In a blog post earlier this year, Kaiser Health News reported on the ease of medical mistakes happening with the slip of a mouse, creating particular concern in rushed emergency-room situations.
In a book on this topic, “The Digital Doctor: Hope, Hype and Harm at the Dawn of Medicine’s Computer Age,” Dr. Bob Wachter, Chief of Hospital Medicine at University of California San Francisco and the “Father of Hospitalist Medicine,” documents some of the harrowing real-life stories.
In one such incident, a teen narrowly escaped death following a hiccup in data processing. Quite routinely, a resident physician had learned she needed to make a change to her original orders for pediatric medication for a boy named Pablo Garcia. So, when the resident typed in 160 mg thinking that was the correct dose to be dispensed, the system changed it to 160 mg/kg. This, plus a series of seemingly minor events, culminated in Pablo taking a gigantic dose of pills.
In July 2015, in an effort to identify the root causes of EHR problems such as this, Pew Charitable Trusts, in collaboration with the Johns Hopkins Armstrong Institute for Patient Safety and Quality, convened a meeting of 70 experts, including EHR vendors, hospital representatives, clinicians, and patient safety advocates.
Following the meeting, Pew identified three primary issues:
1. Some EHR makers don’t fully assess usability of their products before delivering them to hospitals and doctors’ offices.
2. There are no universal standards for measuring the safety and performance of EHR systems.
3. Heathcare providers fear the consequences of violating gag clauses that prohibit disclosure of problems involving their EHRs.
This latter point, relating to gag clauses commonly found in EHR contracts with health providers, means that the public can’t even intelligently assess the current state of EHR technology -- even though $30 billion in federal tax dollars subsidized the installation of EHRs!
Indeed, evidence is stacked high in support of everything Pew says.
Against this backdrop, Medicare persists in giving financial rewards to physicians for how well they score – by Medicare’s standards – in the use of EHRs. And the score-keeping gets into the minutia of everyday routines. For example, physicians get points (which can turn into real money) for generating and transmitting prescriptions electronically.
The end goal, ideally, is about creating a system that rewards doctors for treating patients based on best practices that can be confirmed by data.
However, at the moment, there is a foundational problem: The nation won’t even have the advanced technology for such comprehensive data analysis until 2024. That is by the government’s own estimate in a 2013 report titled, “Capturing High Quality Electronic Health Records Data to Support Performance Improvement.”
The report points to highly functioning EHRs as key to the implementation of payment reform tied to performance measures. It notes that “as the industry moves toward value-based reimbursement—reimbursement based on quality and cost measures—improving the quality of the data used for measurement is imperative.”
Meanwhile, contrary to red flags, Medicare keeps pressuring doctors to step up usage of EHRs in return for higher pay. Right now. Today.
If the functionality of EHR systems is in question, which it clearly is, then Medicare fails the Hippocratic test by forcing these systems to serve purposes they are currently incapable of serving. The only question is: In the process of data entry, how many people are suffering undocumented harm?
In a recent newsletter, the U.S. Office for Civil Rights (ORC) discussed the “insider threat” as one of the largest threats to the security of patient information within organizations. The agency noted that even some cyberattacks may be insider-driven.
According to a recent survey, conducted by Accenture and HfS Research, 69% of organizations surveyed reported experiences with malicious activity on the part of insiders, including current or former employees, contractors and business associates.
According to a survey conducted by the federal government, CSO Magazine, and Deloitte, common e-crimes committed by insiders include:
OCR says organizations should:
The U.S. Office for Civil Rights (OCR) says it is now working with its regional offices to “more widely investigate the root causes of breaches affecting fewer than 500 individuals.” The regional offices will still have discretion on which smaller breaches to investigate, but each office will increase its efforts to address these smaller breaches.
Among other things, regional investigators will look for incidents involving inproper disposal or theft of unencrypted Protected Health Information (PHI), and inappropriate access to IT systems.
Here are examples of settlements in smaller breaches:
St. Elizabeth’s Medical Center, relating to allegations that staff used an internet-based, document-sharing application to store PHI without having analyzed risks: $218,400.
Hospice of North Idaho, relating to an unencrypted laptop computer containing the electronic protected health information: $50,000.
While HIPAA rules require regular training of staff, it's not enough to simply go through the motions of attending a lecture or watching a video. HIPAA education should address things that staff members working with ePHI really need to know. And it should be re-enforced often.
Here are resources from MyHIPAA Guide that can help train staff in the following categories. In addition, watch for our webinars on a variety of HIPAA subjects.
Social Media Guidelines for staff:
Online class, titled Social Media Rules for Healthcare Providers, accredited through our partner, Pedagogy Online Learning Systems.
A published guide on social media uses, from the National Council of State Boards of Nursing.
Security 101 videos on who to spot risks in your midst, and how to plan for natural disasters and interruptions
Basic security checklist for small practices
An advanced online course for compliance managers, titled Responsibilities for Managing HIPAA Compliance, accredited through our partner, Pedagogy Online Learning Systems.
In an unprecedented memo to state survey and credentialing agencies earlier this month, the Centers for Medicare & Medicaid Services directed state survey teams to begin enforcing federal privacy regulations to protect patients from social media abuses. The memo cites recent media reports as impetus for the crackdown.
In its memo, dated Aug. 5, 2016, CMS orders state survey teams to review nursing home policies and procedures related to social media abuses beginning in September, and continuing until all skilled nursing homes have been inspected. The memo points out that staff training alone is not enough, and that compliance must include plans for implementing daily practices that protect residents’ privacy. The memo defines “staff” as employees, consultants, contractors, volunteers and others who provide care services to residents.
Indeed, a growing number of reports are exposing horrific examples of staff members taking embarrassing photos and videos of residents, and then sharing them with friends.
ProPublica and the Washington Post have been especially out front on this issue. Here is some background to give you an idea of what is taking place:
In December 2015, reports co-published by ProPublica and the Washington Post revealed startling social media abuses within long-term care facilities. Indeed, the findings initially documented 37 incidents since 2012, exposing nursing home workers across the country for posting embarrassing photos of elderly residents on social media. In some cases, residents were partially or completely naked. At least 16 cases involved Snapchat, a social media platform where photos appear a few seconds, and then disappear.
Details of the incidents came from government reports, court cases and stories in the media.
An excerpt from one report on the ProPublica website:
“In February 2014, a nursing assistant at Prestige Post-Acute and Rehab Center in Centralia, Wash., sent a co-worker a Snapchat video of a resident sitting on a bedside portable toilet with her pants below her knees while laughing and singing.”
This February at Autumn Care Center in Newark, Ohio, a nursing assistant recorded a video of residents lying in bed as they were coached to say, ‘I’m in love with the coco,’ the lyrics of a gangster rap song (‘coco’ is slang for cocaine). Across a female resident’s chest was a banner that read, ‘Got these hoes trained.’ It was shared on Snapchat.”
In the latter case, the woman’s son told federal investigators that his mother had worked as a church secretary for 30 years, and would have been mortified.
In some cases, employees have faced criminal charges.
Meanwhile, in July, the U.S. Office for Civil Rights announced that federal audits have moved into “high gear” under the Health Information Portability and Accountability Act (HIPAA). Those federal audits are in addition to the inspections that state survey teams have now been ordered to conduct.
Case points to Business Associate Agreements as critical
When it comes to HIPAA enforcement, you can’t hide behind a cloak. That is the message of the federal government’s settlement with the Archdiocese of Philadelphia.
The Diocese will pay $650,000 to settle potential violations under the Health Insurance Portability and Accountability Act (HIPAA), relating to the theft of a mobile device containing protected health information for 412 nursing home residents.
In this and other recent actions, the feds are underscoring an emphasis on holding Business Associates accountable for safeguarding patient information.
In the Philadelphia case, Catholic Health Care Services (CHCS), an agency of the Diocese, performed IT services as a business associate to six skilled nursing facilities. Here is what happened, according to an announcement by the U. S. Office for Civil Rights (OCR):
In April 2014, ORC initiated an investigation following the theft of a CHCS-issued employee iPhone. The iPhone was unencrypted and was not password protected. The information on the iPhone included social security numbers, information about diagnoses, medications and treatments, and names of family members and legal guardians.
Investigators found that CHCS had no policies addressing the removal of mobile devices containing patient information from its facility, and no risk analysis or risk management plan.
The feds signaled they went light on the settlement amount, saying they considered that CHCS provides much-needed services in the Philadelphia area.
The Resolution Agreement and Corrective Action Plan can be found on the OCR website at:http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/catholic-health-care-services/index.html.