New HIPAA Rules for CIOs

Pablo Valerio, International Business & IT Consultant | 1/23/2013 | 14 comments

Pablo Valerio
The US Department of Health and Human Services (HHS) is set to publish a new set of HIPAA rules this week, including stringent privacy and security provisions on how to treat patient privacy. CIOs will need to get ready for some fast and sweeping changes.

The regulations are set to take effect March 26, 2013, with a compliance date of Sept. 21, 2013, for covered entities and business associates.

The rules will establish a new chain of responsibility and legal liability that needs to be addressed immediately, not only by the CIOs at healthcare organizations in all sizes, but also by their counterparts at service providers and business associates, including data miners and IT service providers.

Now CIOs will be responsible for the actions of every business partner and even their partners' partners. "Covered entities must ensure that they obtain satisfactory assurances required by the Rules from their business associates, and business associates must do the same with regard to subcontractors, and so on, no matter how far 'down the chain' the information flows."

The fines for violations of the new rule can go as high as $1.5 million per violation.

That is obviously a huge change. It will require significant reworking of service-level agreements, and it may cause the rethinking of vendor decisions. But that's just the beginning.

Under the new rules, patients will have to give explicit consent or opt-in for any information sharing not directly related to their treatment or insurance benefits. Data miners won't be able to process any personal information without the patient's explicit consent. Also, patients will be able to ask for a copy of their electronic medical information in electronic format.

"Much has changed in health care since HIPAA was enacted over fifteen years ago," HHS Secretary Kathleen Sebelius said in a press release. "The new rule will help protect patient privacy and safeguard patients' health information in an ever expanding digital age."

What issues do CIOs need to address? Many, if we look at the provisions closely.

  • Definition of "data breach": Under the 2009 rules, breaches were defined as incidents that posed a significant risk of financial, reputational, or other harm. Under the new rules, an unauthorized use or disclosure of protected health information is presumed to be a reportable breach unless a covered entity can demonstrate a "low probability" that the information has been compromised. So any incident needs to be reported as a breach, and an assessment needs to be properly documented.
  • Chain of responsibility: CIOs of healthcare organizations, insurance companies, and service providers will need to coordinate efforts to avoid the unauthorized transmission of information and ensure its security.
  • Opt-in for information sharing: The rules will generally require patients to consent in advance before third parties can use their healthcare information to send them marketing information. And that is completely the opposite of the way things are done today.
  • Systems: CIOs need to prepare their systems to provide patients with electronic copies of their health records if requested.

Data breaches are becoming the biggest fear for patients and healthcare organizations. The new rules are important because they will impose a new level of responsibility on people and organizations handling electronic health records. Compliance costs are estimated at $114 million to $225.4 million for the first year.

Leon Rodriguez, director of the HHS Office of Civil Rights, said in the press release:

This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented. These changes not only greatly enhance a patient’s privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a health care provider, or one of their business associates.

That will be great for patients, but for CIOs, it means rolling up your sleeves. Are you ready?

View Comments: Newest First | Oldest First | Threaded View
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Susan Nunziata   New HIPAA Rules for CIOs   1/29/2013 12:35:51 AM
Re: Where does this leave mobility?
@Pablo: Thanks for the additional insights. Much appreciated!
Pablo Valerio   New HIPAA Rules for CIOs   1/25/2013 4:47:43 AM
Re: Where to start
@Curt. The chain of resposibility excludes ONLY some services used to transmit information:

"The conduit exception is a narrow one and is intended to exclude only those entities providing mere courier services, such as the U.S. Postal Service or United Parcel Service and their electronic equivalents, such as internet service providers (ISPs) providing mere data transmission services [...] Such occasional, random access to protected health information would not qualify the company as a business associate. In contrast, an entity that requires access to protected health information in order to perform a service for a covered entity, such as a Health Information Organization that manages the exchange of protected health information through a network on behalf of covered entities through the use of record locator services for its participants (and other services), is not considered a conduit and, thus, is not excluded from the definition of business associate."

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Pablo Valerio   New HIPAA Rules for CIOs   1/25/2013 4:42:40 AM
Re: Where does this leave mobility?
@Susan, I believe the new rule will make healthcare apps -the ones used by any healthcare provider- subject to the same data protection rules, and healthcare providers' CIOs need to seek assurance that the information is secure.

My previous post "Medical Devices & Apps Mine Healthcare Data" deals with the subject. I believe any mobile app or device used in conjuction with electronic records needs FDA approval and HIPAA compliance.

Of course any app used privately by any user to monitor his/her vital signs should be fine. But if used professionally everything changes.
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CurtisFranklin   New HIPAA Rules for CIOs   1/24/2013 11:37:22 PM
Re: Where to start
@Sara, the "chain of responsibility" sounds an awful lot like the chain of liability that a credit card transaction follows. Perhaps there are some valuable lessons healthcare CIOs can learn from the counterparts over in financial services...
Susan Nunziata   New HIPAA Rules for CIOs   1/24/2013 6:47:13 PM
Where does this leave mobility?
@Pablo: one of my twitter followers @MobileAberdeen raises an important question: How will these new rules effect mobile healthcare? What will these new rules mean for m-health solutions?
DBK   New HIPAA Rules for CIOs   1/24/2013 1:46:11 PM
Re: New HIPAA Rules for CIOs
@ Pablo - Thank you for the additional details and points about who owns the EMR data and who has access to that data.  Certainly the patient has a right to know who has viewed that data.  And there is another consideration which is who could have potentially viewed or seen data that is a common spce in a healthcare facility. Does the patient really want to be bothered with details that an electrical contractor was in a space where medical records where "Potentially" visible and they may or may not have seen it?  I doubt it.  But maybe I am over looking or over simplifying the finer details.  Maybe the details are more about the ditigal data.
Pablo Valerio   New HIPAA Rules for CIOs   1/24/2013 10:47:26 AM
Re: New HIPAA Rules for CIOs
@DBK, To me the issue is data ownership and security. I believe this rule goes in the right direction because it is giving patient's privacy more weight than the previous one.

I believe people have the right to know who has any data about themselves, and restrict the transmission of any personal data to third parties. One of the provisions of the new rule is patients have the right to deny sharing any information of their treatments with their insurance companies if they pay cash for those treatments.
Medical information about a patient belongs initially to the patient and not to the healthcare provider. This needs to be the basis for any data sharing, and ensuring that everyone "no matter how far the chain goes" follows the rules is necessary. If that hurts some parts of the industry so be it.

I remember when marketing and advertisement companies in Spain complained about the total ban on tobacco ads, they said several thousand jobs would be lost. Well, that could have been true, but that doesn't mean that we have to allow tobacco ads.
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Pedro Gonzales   New HIPAA Rules for CIOs   1/24/2013 10:05:23 AM
new rules new issues
I think there will be a lot of pressure for health CIO to meet such stringent rules. It is good for patients that such these rules will help maintain the security of their health information as it travels online.
DBK   New HIPAA Rules for CIOs   1/23/2013 1:28:20 PM
Re: New HIPAA Rules for CIOs
Pablo - As a service provider to several healthcare providers the trend that I have seen is that the provider "Out Sources" the vendor conformity.  One such organization is called "VendorMate".  Vendormate and equivalent offer services to the provider to maintain vendor compliance.  They also offer vendor consulting services so the vendor can develop and understanding of what it takes to be in compliance.  It also helps to defer the barrier to entry from a knowledge base.  As the requirements for compliance increase it could leverage smaller organizations out of the picture and position larger groups to be the only ones who can comply.  Dell purchased Perot and that is one of their market segments.  This may just continue to secure thier position in this segment of professional services.
Pablo Valerio   New HIPAA Rules for CIOs   1/23/2013 11:01:19 AM
Re: New HIPAA Rules for CIOs
The difficulty is now that business partners are defined to include subcontractors, this means all subcontractors down the line to the end of the data flow. Every subcontractor involved is going to have HIPAA Security Rule obligations and some of them may not even know it.

But, if your organization is suppose to protect patient's data, is possible to allow BAs to access information without resposibility to keep it safe?
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