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Health IT and ROI (Release of Information) Vendor Sues HHS Over Patient Records Fees

Posted on January 19, 2018 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Now here’s one for the ages – a vendor taking HHS head-on. The vendor, CIOX Health, has sued HHS in an effort to stop the agency from enforcing HIPAA rules limiting how much providers and business associates can charge patient records. While the vendor may not get anywhere, the lawsuit raises the important question of what patient record retrieval should cost.

According to Becker’s Hospital Review, the suit focuses on changes to the privacy law put into place in 2013 and 2016. The article notes that these modifications broadened the type of information providers and BAs must send while capping the fees vendors could charge for doing so. Specifically, the changes made in 2016 require that vendors that the costs associated with record requests for a reasonable or flat rate of about $6.50.

In its complaint, CIOX says the flat fee “was drawn from thin air and bears no rational relationship to the actual costs associated with processing such requests.” It contends that the HIPAA provisions in question established the limits “unlawfully, unreasonably, arbitrarily and capriciously.”

It’s hard to tell whether CIOX will get anywhere (though my guess is “not very far”). Government agencies are all but immovable, and HHS particularly so. I appreciate the spunk involved in filing the suit, the premise of which actually sounds reasonable to me, but I think the company has about as much chance of prevailing as a gnat fighting a combine harvester.

That being said, I think this suit focuses on an important issue, which is that the fee limits imposed by states and the federal government for providing medical records are all over the map. While such limits may be necessary to protect consumers, it’s probably fair to say that they aren’t exactly based on actual estimates of provider and vendor costs.

The truth is, the healthcare industry hasn’t come to grips yet with the cost of delivering healthcare information to patients. After all, while basic information delivered by a portal may be good enough for patients, these aren’t real medical records and they can’t be used as a basis for care.  And delivering an entire medical record can be expensive.

Plus, this issue is really complicated by the number of records requests that healthcare organizations are receiving from parties other than the patient. The number of records request from insurance companies, lawyers, and other third parties has increased dramatically. Not to mention how much of the record these organizations want to get. If it were just patients requesting their records, this question would be much simpler.

I can only think of a few ways to handle this problem, none of which are really satisfactory. For example, HHS or the states could create some sort of system which permits different fees depending on the difficulty of retrieving the information. Providers and business associates could submit their fees to some kind of review board which would approve or reject the proposal. Or perhaps we could just allow vendors to charge whatever the market would bear. None of these sound great to me.

If we want patients to manage their health effectively, they need to be able to share their records, and they must be able to access those records without paying a fortune for the privilege. At the same time, we can’t ask providers and business associates to share records at their own expense. Given the importance of this problem, I think it’s high time that healthcare leaders look for solutions.

HIPAA BAA Proliferation

Posted on October 30, 2017 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

There are a wide variety of forces at work in healthcare that are causing healthcare organizations to outsource more and more of their technology and services. No doubt the move to the cloud has brought in a number of new organizations that didn’t previously host PHI for a healthcare organization. This has added hundreds of outside companies who now have access to your patients’ PHI.

In a recent conversation I had with Rita Bowen and Anthony Murray from MRO at the AHIMA Annual Convention they also commented how many organizations were choosing to outsource their ROI and other services in order to keep their staffing ratios down. What a tremendous insight. We’ve all seen those charts (see the one at the left) that show the growth in provider count over time versus the growth in the number of administrators. We all see these charts and see it as a big problem in healthcare.

In order to combat this perception, it’s no surprise that healthcare organizations are trying to keep these admin to doctor ratios at a better level. One way they’re massaging those numbers is to outsource more of their services. We could talk about whether this is a good strategy or not, but that’s a topic for another blog post. The reality is that these ratios and many other drivers are causing organizations to work with a growing number of outside companies.

I was talking with a hospital CIO who told me that they had 300 different health IT systems. As healthcare organizations have brought on more health IT systems and outsourced many of their services, we have seen what I call HIPAA BAA (Business Associate Agreement) Proliferation. Each of these health IT organizations and outside health services will likely need to sign a BAA.

Healthcare organizations are now managing hundreds of business associate agreements with hundreds of partners. Plus, this doesn’t take into account that many of your BAs also have subcontractors for which they need BAAs and so forth down the line. This cascade of BAAs that are needed by a healthcare organization has to keep a lot of risk managers and HIPAA compliance officers up at night. Unfortunately, I don’t believe that most healthcare organizations are doing a great job managing the hundreds and thousands of BAAs that their organizations need.

Rita Bowen and Anthony Murray from MRO offered one suggestion that could help HIPAA compliance officers and risk managers that are charged with managing the overwhelming task of business associate agreement compliance. They suggested that the volume of BAAs has gotten so large that it’s time to start evaluate BAA vetting efforts based on the amount of information being shared with the business associate. An ROI (release of information) company who has access to all of your patients’ PHI should be vetted differently than an IT service company who may have some tangential access to PHI but has no direct access. Does your BAA vetting process take this into account? My experience is that it doesn’t, but given the volume it probably should.

As health data breaches become more and more common, putting in an effective BAA compliance plan that effectively vets your business associates both during the purchase process and then after purchase and implementation is going to be key. Analyzing a business associate’s access to PHI and risk of being compromised is one strategy healthcare organizations will need to use to better handle BAA proliferation in their organization.

What are you doing to handle BAA proliferation in your organization? Are you seeing this happen? Does this keep you up at night? Let us know your thoughts and experiences in the comments.

2.7 Million Reasons Cloud Vendors and Data Centers ARE HIPAA Business Associates

Posted on July 25, 2016 I Written By

The following is a guest blog post by Mike Semel, President of Semel Consulting.
Cloud backup
Some cloud service providers and data centers have been in denial that they are HIPAA Business Associates. They refuse to sign Business Associate Agreements and comply with HIPAA.

Their excuses:

“We don’t have access to the data so we aren’t a HIPAA Business Associate.”

“The data is encrypted so we aren’t a HIPAA Business Associate.”

Cloud and hosted phone vendors claim “We are a conduit where the data just passes through us temporarily so we aren’t a HIPAA Business Associate.”

“We tell people not to store PHI in our cloud so we aren’t a HIPAA Business Associate.”

Wrong. Wrong. Wrong. And Wrong.

2.7 million reasons Wrong.
Oregon Health & Science University (OHSU) just paid $2.7 million to settle a series of HIPAA data breaches “including the storage of the electronic protected health information (ePHI) of over 3,000 individuals on a cloud-based server without a business associate agreement.”

Another recent penalty cost a medical practice $750,000 for sharing PHI with a vendor without having a Business Associate Agreement in place.

The 2013 changes to HIPAA that published in the Federal Register (with our emphasis) state that:

“…we have modified the definition of “business associate” to generally provide that a business associate includes a person who “creates, receives, maintains, or transmits” protected health information on behalf of a covered entity.

…an entity that maintains protected health information on behalf of a covered entity is a business associate and not a conduit, even if the entity does not actually view the protected health information.  We recognize that in both situations, the entity providing the service to the covered entity has the opportunity to access the protected health information.  However, the difference between the two situations is the transient versus persistent nature of that opportunity.  For example, a data storage company that has access to protected health information (whether digital or hard copy) qualifies as a business associate, even if the entity does not view the information or only does so on a random or infrequent basis.” 

A cloud service doesn’t need access to PHI – it just needs to manage or store it– to be a Business Associate. They must secure PHI and sign Business Associate Agreements.

The free, consumer-grade versions of DropBox and Google Drive are not HIPAA compliant. But, the fee-based cloud services, that utilize higher levels of security and for which the vendor will sign a Business Associate Agreement, are OK to use. DropBox Business and Google Apps cost more but provide both security and HIPAA compliance. Make sure you select the right service for PHI.
Encryption is a great way to protect health information, because the data is secure and the HIPAA Breach Notification Rule says that encrypted data that is lost or stolen is not a reportable breach.

However, encrypting data is not an exemption to being a Business Associate. Besides, many cloud vendors that deny they have access to encrypted data really do.

I know because I was the Chief Operating Officer for a cloud backup company. We told everyone that the client data was encrypted and we could not access it. The problem was that when someone had trouble recovering their data, the first thing our support team asked for were the encryption keys so we could help them. For medical clients that gave us access to unencrypted PHI.

I also know of situations where data was supposed to be encrypted but, because of human error, made it to the cloud unencrypted.

Simply remembering that Business Associates are covered in the HIPAA Privacy Rule while encryption is discussed in the Breach Notification Rule is an easy way to understand that encryption doesn’t cancel out a vendor’s status as a Business Associate.
27864148 - it engineer or consultant working with backup server. shot in data center.
Data Centers
A “business associate” also is a subcontractor that creates, receives, maintains, or transmits protected health information on behalf of another business associate.

Taken together, a cloud vendor that stores PHI, and the data centers that house servers and storage devices, are all HIPAA Business Associates. If you have your own servers containing PHI in a rack at a data center, that makes the data center a HIPAA Business Associate. If you use a cloud service for offsite backups, or file sharing, they and their data centers are Business Associates.

Most data centers offer ‘Network Operations Center (NOC) services,’ an on-site IT department that can go to a server rack to perform services, so you don’t have to travel (sometimes across the country) to fix a problem.  A data center manager was denying they had access to the servers locked in racks and cages, while we watched his NOC services technician open a locked rack to restart a client server.

Our client, who had its servers containing thousands of patient records housed in that data center, used the on-site NOC services when their servers needed maintenance or just to be manually restarted.
37388020 - pushing cloud computing button on touch screen
Cloud-Based and Hosted Phone Services
In the old days, a voice message left on a phone system was not tied to computers. Faxes were paper-in and paper-out between two fax machines.

HIPAA defines a conduit as a business that simply passes PHI and ePHI through their system, like the post office, FedX, UPS, phone companies and Internet Service Providers that simply transport data and do not ever store it. Paper-based faxing was exempt from HIPAA.

One way the world has changed is that Voice Over Internet Protocol (VOIP) systems, that are local or cloud-based, convert voice messages containing PHI into data files, which can then be stored for access through a portal, phone, or mobile device, or are attached to an e-mail.

Another change is that faxing PHI is now the creation of an image file, which is then transmitted through a fax number to a computer system that stores it for access through a portal, or attaches it to an e-mail.

Going back to the Federal Register statement that it is the persistence of storage that is the qualifier to be a Business Associate, the fact that the data files containing PHI are stored at the phone service means that the vendor is a Business Associate. It doesn’t matter that the PHI started out as voice messages or faxes.

RingCentral is one hosted phone vendor that now offers a HIPAA-compliant phone solution. It encrypts voice and fax files during transit and when stored, and RingCentral will sign a Business Associate Agreement.

Don’t Store PHI With Us
Telling clients not to store PHI, or stating that they are not allowed to do so in the fine print of an agreement or on a website, is just a wink-wink-nod-nod way of a cloud service or data center denying they are a Business Associate even though they know they are maintaining PHI.

Even if they refuse to work with medical clients, there are so many other types of organizations that are HIPAA Business Associates – malpractice defense law firms, accounting firms, billing companies, collections companies, insurance agents – they may as well give it up and just comply with HIPAA.

If they don’t, it can cost their clients if they are audited or through a breach investigation.

Don’t let that be you!

About Mike Semel
Mike Semel is the President of Semel Consulting, which specializes in healthcare and financial regulatory compliance, and business continuity planning.

Mike is a Certified Security Compliance Specialist, has multiple HIPAA certifications, and has authored HIPAA courseware. He has been an MSP, and the CIO for a hospital and a K-12 school district. Mike helped develop the CompTIA Security Trustmark and coaches companies preparing for the certification.

Semel Consulting conducts HIPAA workshops for MSPs and has a referrals program for partners. Visit for more info.

Beyond the Basics: What Covered Entities and Business Associates Need to Know About OCR Security Audits

Posted on November 20, 2014 I Written By

The following is a guest blog post by Mark Fulford, Partner in LBMC’s Security & Risk Services practice group.
The next round of Office for Civil Rights (OCR) audits are barreling down upon us, and many healthcare providers, clearing houses and business associates—even ones that think they’re prepared—could be in for an unpleasant surprise. If the 2012 round of OCR audits is any indication, the upcoming audits will most likely reveal that the healthcare industry at large is still struggling to figure out how to implement a compliant security strategy.

Granted, HIPAA regulations are not always as prescriptive as some might like. By design, HIPAA incorporates a degree of flexibility, leaving covered entities and business associates to make decisions about their own approach to compliance based on size, budget, and the risks that are unique to their operations.

But the first round of OCR audits indicated that many healthcare organizations had not even taken the first step in initiating a security compliance strategy—two-thirds of the covered entities had not performed a complete and accurate risk assessment to determine areas of vulnerability and exposure. Apparently, these entities were not necessarily unclear on HIPAA regulations; they simply had not yet made a serious effort to comply.

Out of the 115 entities audited, only 13 had no findings or observations (11%). This time around, the expectation will be that covered entities and business associates will have taken note of the 2012 audit findings, and that the effort to comply will be much improved.

All covered entities and business associates may be subject to an OCR audit. If you have not yet conducted an organizational risk assessment, now would be the time to do so. The OCR provides guidelines, and you can also reference the Office of the National Coordinator for Health Information Technology (ONC) and standards organizations like the National Institute of Standards and Technology (NIST). Additionally, the OCR has released an Audit Program Protocol to help you better prepare.

Five Key Areas to Address for OCR Audit Preparation

Based on our experience in the healthcare industry and consistent with the 2012 OCR Audit findings and observations, here’s how you can prepare for the upcoming OCR audits:

  • Know where your data resides. Many organizations fail to account for protected health information (PHI) in both paper and electronic forms. Between legacy systems (where data might be not well-indexed), printed copies (data could be abandoned in a desk) and mobile device use (data could be anywhere), large volumes of at-risk data is often floating around in places it shouldn’t be. In the first round of OCR audits, issues with security accounted for 60% of the findings and observations. To avoid falling into that trap, do a thorough inventory of your PHI and make decisions on how to handle and store it going forward.
  • Review business associate agreements. Business associates were not included in the 2012 OCR audits, but they will be this time around. If any of your business associates are found to be non-compliant, you will most likely be included in the subsequent investigation. Ask your accounting and IT departments to prepare a list of all third parties with whom you share PHI. Make sure your agreements are up-to-date and that your vendors are making good faith efforts to be in compliance. Due diligence can be accomplished through the use of questionnaires, your own audit, or a third-party assurance (e.g., a Service Organization Control (SOC) or a HITRUST report). And if you are a business associate, be aware that you, too, could be selected for an audit.
  • Establish a monitoring program. Your system, firewall and antivirus/antimalware software all regularly log system events. But beyond logging data, HIPAA dictates that you actively review the data to identify suspicious activity. If you haven’t already, assign an individual the task of reviewing your data for anomalies. Also, plan on conducting regular sweeps of the office to make sure that all printed documents are being stored and disposed of properly.
  • Identify breach reporting procedures. The Omnibus HIPAA rule has since updated the breach reporting requirements that were first outlined in HITECH. Make sure your breach reporting procedures are compliant with the most recent standards. While the 2012 OCR audits reported only 10% of their findings associated with the Breach Rule (as opposed to 30% and 60% associated with the Privacy and Security Rules respectively), failure to have a compliant breach reporting process could be a major problem if you are audited.
  • Schedule Staff Training. Most breaches are the result of human error. HIPAA requires that regular security training and security reminders be an integral part of your healthcare compliance strategy. Twenty-six percent of the Administrative Requirements findings and observations in the 2012 OCR audits involved training issues. Don’t assume that your employees know how to handle sensitive data. (Even if they do, it’s easy to forget.) Constant reminders create a culture of accountability that holds each individual responsible for protecting patients’ confidential health information.

While OCR audits give the OCR an opportunity to step up enforcement of HIPAA rules, anyone can register a complaint against you at any time. Thorough preparation for the upcoming OCR audits not only ensures that you will pass one if you are selected, it also protects you from breach, patient complaints, and general loss of public trust and good will.

About Mark Fulford
Mark Fulford is a Partner in LBMC’s Security & Risk Services practice group.  He has over 20 years of experience in information systems management, IT auditing, and security.  Marks focuses on risk assessments and information systems auditing engagements including SOC reporting in the healthcare sector.  He is a Certified Information Systems Auditor (CISA) and Certified Information Systems Security Professional (CISSP).   LBMC is a top 50 Accounting & Consulting firm based in Brentwood, Tennessee.

Brand Damages More than Legal Damages in HIPAA Violation

Posted on July 9, 2013 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I was recently discussing with someone the possible legal damages of a HIPAA violation by a healthcare organizations business associate. We all know that thanks to HIPAA omnibus, the business associate will now be held liable for any HIPAA breaches or violations that occur. One question I haven’t seen addressed was whether the covered healthcare organization entity would be held responsible for the business associates breaches or violations. Before, the healthcare organization would be the only one with consequences. Are the consequences for the healthcare organization still the same if a business associate has a HIPAA breach?

I think the answer probably depends on the business associate agreement. Although, maybe you can’t shield yourself of liability from business associates negligence just with a well done business associate agreement. Hopefully some of me healthcare lawyer readers can shed light on this subject.

One thing I am sure of is that the legal damages pale in comparison to the damages to a brand when a HIPAA violation occurs even when the violation is completely the responsibility of the business associate. Healthcare organizations are still going to be held responsible for the violation. No doubt we’ll hear the phrase, “the healthcare organization should have properly vetted and checked that their business associates were following HIPAA.”

While we can all agree that many healthcare organizations aren’t as diligent as they should be with business associates, should the healthcare organization have to babysit all of their business associates?

Like most things in life, there has to be a balance. You can’t play big brother with all of your business associates. You’ll drive your business associates crazy and waste a lot of resources in the process. However, I think we can look to HIPAA for the guidelines. Every healthcare organization should have a well thought out understanding and process for how they decide who they work with as business associates.

The reality is that regardless of who takes on the legal consequences of a HIPAA violation, the healthcare organization is the one that has to worry most about the damage to their brand.

HIPAA Omnibus – What Should You Know?

Posted on March 26, 2013 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I had the great opportunity to sit down with HIPAA expert, Rita Bowen from HealthPort, at HIMSS 2013 and learn more about the changes that came from the recently released HIPAA Omnibus rule. The timing for this video is great, because today is the day the HIPAA Omnibus rule goes into effect. In the video embedded below, Rita talks about what you should know about the new HIPAA changes, the new business associate requirements, and restricting the flow of sequestered health information.

The Final HIPAA Omnibus Rule: A Sharing of Accountability

Posted on February 25, 2013 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The following is a guest post by Rita Bowen, MA, RHIA, CHPS, SSGB, SVP of HIM and Chief Privacy Officer, HealthPort. If you’re attending HIMSS, I’ll be doing an interview with Rita at HealthPort’s Booth 6841 at Noon on Tuesday 3/5/13. Come by and learn more about the HIPAA Omnibus Rule and get any questions you have answered.

It seems an eternity ago, four years to be exact, that the HITECH Act introduced changes to HIPAA. After much speculation, rumor, innuendo and anticipation, HHS released the final HIPAA omnibus rule, which significantly amends the original HIPAA Privacy, Security, Breach and Enforcement Rules. HHS Secretary Kathleen Sebelius introduced the new rule by stating:

“The final rule greatly enhances a patient’s privacy protections, provides individuals new rights to their health information, and strengthens the government’s ability to enforce the law.”

Ms. Sebelius conceded that healthcare has changed dramatically since HIPAA was first enacted and that the new rule is necessary to “protect patient privacy and safeguard patients’ health information in an ever expanding digital age.”

The new rule, at 563 pages, is not brief, but covered entities can’t let that inhibit them from becoming intimately acquainted with this document. I’ve made an initial review of the rule and culled what I feel are its key concepts:

  • Business Associates (BAs) of covered entities are now, for the first time, directly liable for compliance with certain requirements of HIPAA Privacy and Security rules, including the cost of remediation of breaches for which they are responsible.
  • The rule goes so far as to revise the definition of a “breach.” This new definition promises to make the occurrence of breaches – and the required notification of breaches — more common.
  • The use and disclosure of protected health information for marketing and fundraising purposes is further limited, as is the sale of protected information without individual authorization.
  • The rule expands patients’ rights to receive electronic copies of their health information and to restrict disclosures to health plans regarding treatment for which they’ve already paid.
  • Covered entities are required to modify and redistribute their notice of privacy practice to reflect the new rule.
  • The new rule modifies Individual authorizations and other requirements to facilitate research, expedite the disclosure of child immunization proof to schools, and enable access to decedent information by family members and others.
  • The additional HITECH Act enhancements to the Enforcement Rule are adopted, including provisions addressing enforcement of noncompliance with HIPAA rules due to willful neglect.

Getting to Compliance

And now comes the challenging part – compliance! The new rule goes into effect on March 26, and covered entities and BAs are expected to comply by September 23, so there is much work to do. Hospitals and clinics need to thoroughly comprehend — and then prepare for — the sweeping changes in BA liability. They’ll need to communicate these changes and new requirements to BAs and update their BA agreements accordingly. And since BAs are now directly liable for breaches, organizations must decide how they’ll enforce their BA agreements with regard to privacy and security. Additionally, comparable agreements must now be shared between BAs and their subcontractors.

What are the keys to successful compliance?  The following tips should ensure your smooth transition into the new rule:

  • Become intimately acquainted with the new rule — and its ramifications for your organization, your BAs, and their subcontractors.
  • Identify a privacy officer within all of your partner organizations.
  • Define a process for the notification of patients in the event of a breach of their protected health information (PHI).
  • Update breach notification materials to reflect the new Rule.
  • Update, repost and redistribute your Notice of Privacy Practices.
  • Document current privacy and security practices, and conduct a risk assessment.
  • Make certain your healthcare security technology solution is flexible, secure, and scalable to handle the growing volume of audit inquiries promised by the RACs.
  • Encrypt all devices that store patient information.
  • Communicate new HIPAA requirements and expectations to BAs.
  • Update business associate agreements (BAAs) to clarify that BAs pay the cost of breach remediation, when the BA is responsible for the breach.
  • Provide a template of a comparable agreement for BAs to use with their subcontractors.
  • Monitor your partners’ efforts to protect patient data.

The new HPAA omnibus rule has arrived and the challenges it presents should not be underestimated. Communication and organization will be your keys to success!

Rita Bowen, MA, RHIA, CHPS, SSGB

Ms. Bowen is a distinguished professional with 20+ years of experience in the health information management industry.  She serves as the Sr. Vice President of HIM and Privacy Officer of HealthPort where she is responsible for acting as an internal customer advocate.  Most recently, Ms. Bowen served as the Enterprise Director of HIM Services for Erlanger Health System for 13 years, where she received commendation from the hospital county authority for outstanding leadership.  Ms. Bowen is the recipient of Mentor FORE Triumph Award and Distinguished Member of AHIMA’s Quality Management Section.  She has served as the AHIMA President and Board Chair in 2010, a member of AHIMA’s Board of Directors (2006-2011), the Council on Certification (2003-2005) and various task groups including CHP exam and AHIMA’s liaison to HIMSS for the CHS exam construction (2002).

Ms. Bowen is an established speaker on diverse HIM topics and an active author on privacy and legal health records.  She served on the CCHIT security and reliability workgroup and as Chair of Regional Committees East-Tennessee HIMSS and co-chair of Tennessee’s e-HIM group.  She is an adjunct faculty member of the Chattanooga State HIM program and UT Memphis HIM Master’s program.  She also serves on the advisory board for Care Communications based in Chicago, Illinois.

HITECH Privacy Compliance Gets Trickier – Meaningful Use Monday

Posted on July 9, 2012 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

It’s been a very interesting few weeks for privacy protection under  HIPAA. Just in case you haven’t had a chance to catch up on them,  here’s what’s going on.  The OCR has announced the protocols under which it’s going to perform audits required by HITECH.

Here’s how OCR is going to check both you and business associates for compliance with the HIPAA Privacy Rule,  Security Rule and Breach Notification Rule. Here’s a summary from the Beyond Healthcare  Reform blog from lawfirm Faegre Baker Daniels:

Privacy Rule Security Rule
Notices of privacy practices Administrative Safeguards
Right to request privacy protection for PHI Physical Safeguards
Access to PHI Technical Safeguards
Administrative requirements
Uses and disclosures of PHI
Amendment of PHI
Accountings of disclosures

Meanwhile, there’s the matter of the temperature being turned up on your relationship with your business partners. As things stand, maintaining HIPAA-level control over information once it leaves your facility or office is hard enough.  Since 2009, HITECH has required covered entities and business associates to disclose if they’d used information on patients — including for treatment, payment or operations — if the access was through an EMR.

While that’s sticky to enforce, it mostly affects providers, not the business associates in most cases. But things could get a little trickier going forward.  A new proposed rule would now require a basic access report applying not just to EMRs, but also to uses and disclosures of e-PHI in a designated record set.

As the Beyond Healthcare Reform blog notes, this could mean that health plans and business associates (if they have a designated records set) would have to provide the access reports for everything, including treatment, payment and operations.

I doubt any of us are surprised to see OCR getting tougher on data sharing;  in fact, I’d argue that it’s overdue. The question is whether in the mean time, the near-daily data breaches we see (stolen laptops with unencrypted data, lost data disks) still haunt us.  Scary times.

Be Sure That Business Associates Are HIPAA-Prepared, Or Else

Posted on June 6, 2012 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Sure, most readers will know that it’s important to have business associates who know how to handle potential HIPAA concerns.  I’d wager, however, given the outbreak of partner-related data losses of late, many facilities and medical practices aren’t subjecting their business partners to severe enough scrutiny.

There’s many, many ways a business associate can drop the ball, especially if you’re not keeping them informed.  For example, consider the case of South Shore Hospital of South Weymouth, MA, which lost boxes of unencrypted backup tapes en route to associate Archive Data Solutions.  The tapes stolen included HIPAA-protected ePHI (SSNs, names, financial account numbers and diagnoses).

While the business associate may have done wrongly, it was the hospital which was fined a total of $475,000 over the incident, which affected over 800,000 individuals. The state’s Attorney General slapped the hospital with these fines because it hadn’t done due diligence to make sure the associate had appropriate safeguards in place.

So, how do you protect yourself in your relationship with data management associates?  The following list of criteria, supplied by Thu Pham, seem likely to do the trick:

  • Business associate has been independently audited across all 54 HIPAA citations and 136 audited components; they’ve passed with 100% compliance and can show you a copy of their report.
  • They can tell you the particular technologies they’ll use to meet HIPAA security standards.
  • They have documented policies and procedures already in place, including policies related to breach notification.
  • They have proof their employees are trained on how to handle your PHI, with last completed dates of training.
  • They should have their own business associate agreement in place that defines their responsibilities when handling your PHI.

I might also ask them how they train their workers, as all of this preparation might be worth a lot less if policies are loose.  Now, over to you. Do you think this list is sufficient to protect your institution?  Are there items you’d add or clarify?

Guest Post: HIPAA Responsibility – Whether You Want It or Not

Posted on March 21, 2012 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Guest Blogger: Jan McDavid is General Counsel and Compliance Officer at HealthPort, a Release of Information and Audit Management Technology company. You can read more of Jan’s posts on the HealthPort blog.

John Lynn’s post “Covered Entity is Only One with Egg on Their Face” is good warning to healthcare providers: as HIPAA enforcement gains teeth, you are responsible for breaches caused by your business associates. The increase in HIPAA enforcement, penalties and current ONC audits make it clear that ignorance of adherence to HIPAA by your business associates (BA) is not a valid strategy.

In fact, the Poneman Institute Study cites 46 percent of breaches as caused by BAs, yet the covered entity (CE) is responsible for 100 percent of them from a legal prospective.

The time for inaction regarding your BAs is over. Now is the time to confront the issue head-on. The good news is that it costs less in the long run to prevent breaches than it does to pay for breaches committed by your BAs. Here’s how to get started.

It’s Time to Act

The same policies and procedures that you have implemented for yourself are applicable to your BAs. Of course, since the BAs do not report through your organization, the best way to assume compliance is through your contracting process.

It is not enough to just put it in the contract. In the old “trust but verify” school of management, your contract must also contain avenues of verification. That can include surveys, reports, audits, policy and procedure manuals, etc. This due diligence at contracting time pays off in many ways when ONC auditors knock on your door.

The due diligence must be a continual process, not just “once and done”. The laws are changing and Health and Human Services (HHS)’s Office of Civil Rights (OCR) is implementing new risk audits in 2012 to test your readiness. New breach notification and accounting of disclosure rules are imminent and will further tighten the laws. Also, many institutions focus on the Privacy Rules, while paying less attention to the Security Rules. The privacy rules focus on the “what,” while the security rules focus on the “how” of compliance.

To protect yourself, you should be doing self assessments using both internal and external auditors. Anything you do for yourself should be considered for your business associates.

Simple Encryption Goes a Long Way

Most accidental large-scale breaches are caused by lost or stolen electronic devices. The small one or two patient breaches are much less of a publicity problem but still require a risk assessment. The small breaches are going to happen; it is inevitable. The large breaches carry a higher degree of severity.

To prevent large breaches, it is essential that BAs which use electronics have the same tight policies and procedures in place that you do (or should). They can go beyond the HIPAA-mandated policies. One practice that should be implemented is encryption.

Remember, a lost electronic device that contains encrypted data is not considered a reportable breach. Encryption is a logical first step that, while not yet HIPAA mandated, will save considerable pain and expense over time. Notice it is only a first step. There are other security technologies available that will call a central location to pinpoint a device’s location. Further, they can wipe themselves clean if not accessed properly or in a given timeframe.

Paper Breaches Also a Concern

And providers shouldn’t lose sight of paper medical records and how BAs are using them. In fact, many breaches to date have involved paper. Understand how your BAs use paper records and patient information. Is it going off site? If so, there should be established policies and procedures.

Any access to paper records and appropriate destruction of those records must be HIPAA compliant. Locked bins for disposal and state-of-the-art shredders are a must at the provider’s site and the BA’s office. Do not let paper records lay around on desks and make sure all personnel are trained in the handling of paper records.

Training and Education for All

Training and educating are the foundation of any compliance program. BAs should have an in-depth training and education program that is as robust as that of the covered entity. Best practices make training an ongoing, living process with regular updates and mandatory attendance at classes.

Making the effort to fend off unauthorized disclosures will go a long way toward mitigating risk. Staying in front of the threat curve is difficult but not impossible. Remember to apply lessons learned to your BAs so you aren’t the only one with egg on your face!