Safe & Sound with Marianne Kolbasuk McGee

The Shutdown's Collateral Damage

Patient Privacy, Security and Well-Being at Stake

At the heart of the federal budget stalemate in Washington is the Tea Party's effort to pull the plug on Obamacare. But the resulting partial government shutdown is derailing other important healthcare efforts that not only impact patients' data security and privacy, but also, in some cases, their well-being.

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Among the 42,000-plus furloughed workers at the Department of Health and Human Services are essentially the entire staffs of the Office for Civil Rights, which enforces HIPAA, and the Office of the National Coordinator for Health IT, which develops guidelines for the HITECH Act's electronic health record incentive program.

A message on OCR's HIPAA complaint portal acknowledges that HHS won't be looking into any new privacy violations during the shutdown.

"Due to the absence of either an fiscal 2014 appropriation or continuing resolution for HHS, this site will not be accepting new submissions. When either a fiscal year 2014 appropriation or continuing resolution for HHS is passed, this site will again accept submissions. Thank you for your patience."

Also out of action are OCR breach investigations, planning for the 2014 HIPAA compliance audit program, and enforcement of the HIPAA Omnibus Rule.

ONC Programs on Hold

Meanwhile, the virtual shutdown of the ONC means getting answers to many technical questions about Stage 2 of the HITECH Act EHR incentive program, which launched Oct. 1, program is impossible.

An ONC website lists certified EHRs that qualify for the HITECH Act incentive program by meeting specific criteria, including privacy and security features. But the list now only reflects EHR products that were certified as of Sept. 27 as meeting Stage 2 requirements.

ONC notes on its website that while independent authorized testing labs and certification bodies will continue to test and certify EHR technology during the partial government shutdown, newly certified products will not be listed on ONC's database "until the end of a government shutdown owing to the requirements of ONC review and validation procedures."

The website also notes that, "ONC staff and contractors will not be available for technical support, assistance or programming during a government shutdown."

In addition, work on new regulations spearheaded by ONC and OCR, many of which are designed to protect patient privacy, also is stalled during the shutdown. That includes work on the long-awaited accounting of disclosures rule (see: Concerns Voiced About Disclosure Rule).

Bigger Issues

While the work-stoppage at OCR and ONC might result in inconvenient delays, it's important to acknowledge that some other HHS programs affected by the shutdown potentially have far more serious consequences.

For instance, at the National Institutes of Health, the shutdown means no new patients can be admitted into its own clinical studies. Fortunately, HHS has decided to allow some furloughed NIH staffers back to work on Oct. 4 to resume accepting applications for registering clinical trials to be conducted at hospitals and elsewhere. But every day of the shutdown is one less day of hope for some patients - including those with potentially terminal illnesses who were hoping to participate in NIH clinical studies.

Plus, the HHS website for contingency staffing states that during the shutdown, the Centers for Disease Control and Prevention is "unable to support the annual seasonal influenza program, outbreak detection and linking across state boundaries using genetic and molecular analysis, continuous updating of disease treatment and prevention recommendations ... and technical assistance, analysis and support to state and local partners for infectious disease surveillance."

So what is CDC doing the shutdown, you ask? "CDC will continue minimal support to protect the health and well-being of U.S. citizens here and abroad through a significantly reduced capacity to respond to outbreak investigations, processing of laboratory samples and maintaining the agency's 24/7 emergency operations center," HHS states.

The bottom line is that the longer this shutdown drags out, the worse the impact will be.

About the Author

Marianne Kolbasuk McGee

Marianne Kolbasuk McGee

Executive Editor, HealthcareInfoSecurity, ISMG

McGee is executive editor of Information Security Media Group's media site. She has about 30 years of IT journalism experience, with a focus on healthcare information technology issues for more than 15 years. Before joining ISMG in 2012, she was a reporter at InformationWeek magazine and news site and played a lead role in the launch of InformationWeek's healthcare IT media site.

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