Health IT Law Blog : Health IT Law Blog : Post & Schell: Law Firm : HIT & Electronic Health Records

Breaches are not always caused by lost laptops or hackers.  They often result from simple errors by the hospital's or another provder's own staff.  In a very recent example, the California Department of Public Health found two instances of serious mishandling of protected patient information at Children's Hospital of Orange County.  Via Orange County Register:

In the first instance, the state found that after a doctor called to give the hospital a new fax number, patient records were instead sent to an auto business. Six faxes with health care information were picked up from the business, the report says.

A month later, the auto shop again notified the hospital that it had received a fax with a patient's name, date of birth and details of visits. The hospital discovered that the wrong fax number had not been changed in a data base.

Hospital staff said the breach would have been prevented if a test fax had been sent as required by hospital policy, the report said.

The other privacy breach occurred when the name of an emergency room patient's doctor was incorrectly entered into the system. Records were then faxed to the wrong doctor who notified the hospital.

CHOC is auditing its database to make sure information is accurate.

It is not clear whether CDPH is going to impose a fine on CHOC like the agency did earlier this month to five different hospitals. Regardless, this episode should serve as a great reminder for healthcare providers about how simple mistakes can lead to costly and highly embarrassing data breaches, especially in instances where the provider fails to adhere to its own privacy policy. 

"State blames CHOC in wrong-site surgery," Orange County Register (June 25, 2010).

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On June 18, 2010, the Office of National Coordinator for Health IT issued a final rule, 45 CFR Part 170, establishing a temporary EHR certification program for the purposes of testing and certifying health information technology.

The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify Complete Electronic Health Records (EHRs) and/or EHR Modules, thereby making Certified EHR
Technology available prior to the date on which health care providers seeking incentive payments available under the Medicare and Medicaid EHR Incentive Programs may begin demonstrating meaningful use of Certified EHR Technology.

You can find the new final rule here.

You can find ONC's "Fact Sheet" and Q&A regarding certification here.

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The number of reported health information breaches is growing rapidly: 32 breaches were reported on the OCR web site from September 2009 to February 2010, but the number almost tripled, to 93 breaches, by June 11, 2010.  Such significant increases in reported breaches may be attributed to the notification and reporting requirements in the HITECH Act, which went into effect this year.  We cannot possibly report or list all of the relevant breaches, but we would like to highlight a few important ones:

• On May 28, 2010, Cincinnati.com reported that “Cincinnati Children's Hospital Medical Center is beefing up its computer security after a laptop computer containing more than 61,000 patient records was stolen.”  Information lost included not only PHI, but also Social Security numbers and even credit card data.  The records on the laptop were password protected, but they were not encrypted.  The hospital reported the breach, hired a consulting company to deal with same, and offered affected individuals ID theft protection at no charge.  The cost of this breach has already been extremely high, but it could be even higher if credit card companies go after Children's Hospital for losses associated with loss of improperly stored credit card information. 

• Five hospitals in California were fined a combined total of $675,000 by the California Department of Public Health for patient privacy violations, failing to prevent unauthorized access to confidential patient medical information of 245 patients, which were improperly accessed by a total of 32 employees.  On June 10, 2010, Press-Enterprise reported that the Community Hospital of San Bernardino was fined by the state of California a total of $325,000 for breaches of more than 200 patient records by two employees in 2009.  Violations were significant, but, considering the fine, far from gruesome.

Please click here to read more.

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Via Health Leaders Media:

OCR will release proposed rules later this month [or 'about two weeks or around June 26th'] on most of the HIPAA privacy and security-related provisions in HITECH, according to the North Carolina Healthcare Information and Communications Alliance (NCHICA).

<...> NCHICA reports the proposed rules will not include accounting for disclosures, which will be the subject of a separate proposed rule. The NPRM will also include clarification regarding "willful neglect" (penalty tiers).

Currently, that represents the most egregious breach of unsecured PHI and can include a penalty of at least $1.5 million under new HITECH tiers in the enforcement final rule.

The state alliance also reports state attorneys general (SAG) are "developing training programs, including information for SAG staff, covered entities and business associates regarding HIPAA requirements and processes for filings with HHS, based on lessons learned from the first AG filing in Connecticut." Under HITECH, state AGs can pursue lawsuits for HIPAA violations, and Connecticut's AG was the first to do so.

OCR is expected to begin its HITECH-required compliance audits next year, the alliance reports. OCR's audits will be outsourced because its resources are limited, according to the e-mail.

"Much remains to be decided," Susan McAndrew, JD, deputy director for Health Information Privacy, for OCR, said in the "Quiz the Regulator" session on June 7.

"State Alliance: Proposed HITECH Regulations Coming in Two Weeks," Health Leaders Media (June 15, 2010).

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On June 7, 2010, Maryland's Lt. Governor Anthony Brown announced that the Office of National Coordinator for Health IT approved Maryland's State Health IT plan, allowing the state to move forward to implement a functional health information exchange (HIE).  According to the Washington Business Journal, ONC will release $25 million in ARRA funds to Maryland, to be used in connection with the state's HIE:

Proponents of the exchange say it will cut costs and improve health care quality by streamlining the transfer of electronic health data between hospitals, physicians and patients.

The Chesapeake Regional Information System for our Patients, the nonprofit tasked with implementing the exchange, has already begun work with $10 million in state money. The federal approval leaves the plan's funding "fully unrestricted," said CRISP Program Director Scott Afzal, allowing them to broaden the goals of the exchange and engage more hospitals. Much of their work lies in finding health care providers to sign on to the exchange when there is no state or federal legal requirement to do so, according to Afzal.

'We have to show a value proposition to connect,' he said.

The project is estimated to cost roughly $20 million, although it will be scoped to available funding.

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Allscripts and Eclipsys announced a $1.3 billion merger, which some analysts tout as a match "made in heaven" due to Allscripts's strength in the ambulatory space and Eclipsys's strength on the acute side.  The merger is expected to be completed in four to six months; the combined company will have around 5,500 employees.  The merger will also pose some challenges for the combined entity, with some customers worrying that the merger will distract management from dealing with existing issues.  However, analysts believe that Allscripts's smooth merger with Misys in 2008 is a good sign that this merger with Eclipsys will succeed.

Both companies are looking to capitalize on the projected exponential growth in adoption of health IT, in part due to the incentives created by ARRA.  According to the Congressional Budget Office, adoption of electronic health records by physician practices is expected to increase from 12% in 2011 to 90% by 2019. 

This merger is yet another sign of future consolidation in the healthcare industry, both on the vendor side, and on the provider side, as enterprises try to minimize costs and maximize revenue in the ever-changing and often uncertain business environment.

"Allscripts-Eclipsys: 'A match made in heaven' - mostly," Healthcare IT News (June 10, 2010).

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Upon request from members of Congress, the Federal Trade Commission (FTC) has once again pushed back the enforcement of the Red Flags Rule, this time until December 31, 2010.  This is the fifth such delay by the FTC.  Via FTC press release:

The Rule became effective on January 1, 2008, with full compliance for all covered entities originally required by November 1, 2008. The Commission has issued several Enforcement Policies delaying enforcement of the Rule. Most recently, the Commission announced in October 2009 that at the request of certain Members of Congress, it was delaying enforcement of the Rule until June 1, 2010, to allow Congress time to finalize legislation that would limit the scope of business covered by the Rule. Since then, the Commission has received another request from Members of Congress for another delay in enforcement of the Rule beyond June 1, 2010.

The Commission urges Congress to act quickly to pass legislation that will resolve any questions as to which entities are covered by the Rule and obviate the need for further enforcement delays. If Congress passes legislation limiting the scope of the Red Flags Rule with an effective date earlier than December 31, 2010, the Commission will begin enforcement as of that effective date.

We have recently reported on the AMA and other medical associations suing the FTC over applicability of the Rule to healthcare providers.  There was no mention of the AMA's claims or law suit in the press release.

You can read the full press release here.

"FTC Extends Enforcement Deadline for Identity Theft Red Flags Rule," FTC Press Release (May 28, 2010).

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