Audit criticizes OCR and ONC over data privacy efforts

HHS's own Office of Inspector General (OIG) issued a scathing report regarding pervasive breaches in privacy and security of patient data. OIG specifically called out the Office of Civil Rights (OCR), charged with enforcement of HIPAA Privacy and Security Rules, for failing to investigate and punish the vast majority of violators.

The audit tested seven hospitals' compliance with HIPAA in seven different states, and found 151 vulnerabilities in the systems and controls intended to cover e-PHI, 124 of which were categorized as "high-impact" (i.e., ones which may result in costly losses, injury or death.)  Violations included unencrypted wireless connections, easy passwords, and even a taped-over door lock on a room used for data storage. Via Modern Healthcare:

The audits of the seven hospitals revealed weaknesses in hospital IT defenses of electronic protected health information, or ePHI, ranging from the fact that several hospitals still were using obsolete and vulnerable encryption protocols to the fact that all seven had vulnerable access controls in which “Outsiders or employees at some hospitals could have accessed, and in one hospital did access, systems and beneficiaries' personal data and performed unauthorized acts without the hospitals' knowledge.”

“These vulnerabilities placed the confidentiality, integrity and availability of ePHI at risk,” the auditors said. The individual hospital audit reports were not disclosed “because the reports contained restricted, sensitive information that may be exempt from release under the Freedom of Information Act,” according to the report.

 

OIG also criticized the Office of National Coordinator for Health IT (ONC) for their failure to develop standards ensuring privacy and security of patient data as part of ARRA's push for digitizing medical records:

As a yardstick for ONC performance as a security champion, the inspector general's auditors reviewed last year's ONC-developed interim final rule and final rule on standards, implementation specifications and certification criteria for the ARRA-funded electronic health record system incentive payment program. The auditors found both wanting.

The report's authors differentiated between two types of security measures. One they described as “application security controls” that “function inside systems or applications to ensure that they work correctly.” Such measures include security controls covered by the ONC final rule and used in testing and certification of electronic health-record systems as able to meet meaningful-use requirements for providers participating in the federal IT incentive payment programs. An example is a requirement that certified EHRs be able to encrypt data shared between providers.

The auditors called the other type of measures “general information technology security controls,” described as “structure, policies and procedures that apply to an entity's overall computer operation.”

An example would be a policy that requires providers to use encryption software on their systems and encrypt all data copied from an EHR and placed on a portable storage device, such as a laptop, CD or a portable thumb drive. The auditors found that the ONC had included application controls in writing its interoperability specifications for meaningful use, but that "there were no (health IT) standards that included general IT security controls.”

Other examples of general controls not addressed by the ONC but suggested for development by the report would be requirements that providers use two-factor authentication to gain access to an organization's health IT system and policies that mandate that organizations install “patches” or bug fixes in a routine and timely manner to computers that process and store EHRs.

"Audit reports hit HHS on digital security," Modern Healthcare (May 17, 2011).

 

Study: Data Breaches Cost U.S. Hospitals Billions

A new study by the Ponemon Institute concluded that data breaches cause enormous losses for U.S. hospitals:  on average, over a two-year period, each hospital will incur about $2 million in losses due to data breaches, which results in $12 billion cumulative loss for all U.S. hospitals.

The study also found that:

  • Most healthcare organizations experience undetected breaches of patient data due to lack of preparation and staffing. 71% of healthcare organizations reported having inadequate resources, 52% reported having appropriately trained personnel, and 69% reported having insufficient policies and procedures in place to prevent and quickly detect patient data loss; thus leaving such organizations with little or no confidence in their ability to appropriately secure patient records.
  • Protecting patient data is not a priority for 70% of hospitals, with 67% reporting having less than 2 staffers dedicated to privacy and security issues.
  • 71% do not believe the new federal regulations pursuant to the HITECH Act have significantly changed the management practices of patient records.

 According to the Wall Street Journal's Health Blog:

  • A full 60% of the organizations included in the study had more than two data breaches over the previous two years, at a cost of $2 million per organization.

 

  • The average breach involved 1,769 lost or stolen records.

 

  • Senior personnel at the organizations surveyed felt unprepared to prevent or quickly detect breaches. Some 58% of the organizations “have little or no confidence” in the ability of their organization to detect all patient data loss or theft.

 

  • Patients were the first to detect data breaches, report 41% of the organizations.
  • Most of the respondents have either put in place an electronic medical records system or are in the process of doing so. And 74% of those with an EHR system say it has made data more secure. Another 12% said the system made no difference in security, 10% say it made data less secure and 4% were unsure.

You can read the full study by registering here.

"Study: Data Breaches Cost Hospitals $6 Billion Per Year," WSJ Health Blog (November 9, 2010).

 

Study: Less than 7% of doctors email patients

According to a new study by the Center for Studying Health System Change, less than 7% of U.S. physicians communicate with their patients via e-mail. According to the Wall Street Journal, most physicians did not have access to electronic health records or other health information technology allowing secure communication with patients online. Yet even among those physicians with access to such technology, only 19.5% reported communicating with patients via email regularly.

Via the Journal:

This survey didn’t ask non-emailing physicians why they weren’t trading LOLs and emoticons with their patients, but the CSHSC brief has a host of previously cited reasons: “lack of reimbursement, the potential for increased workload, maintaining data privacy and security, avoiding increased medical liability and the uncertain impact on care quality.” (Given that list, it’s hard to figure out why any physician would choose to email patients.)

Doctors working in practices the have already converted to electronic medical records were more likely to communicate with patients via email. So were physicians in HMOs or academic centers, compared to those in solo or two-doctor practices.

 

 Given the reimbursement issue, it’s not surprising that physicians on a fixed salary were more likely to communicate with patients than those with other compensation arrangements. (Aetna and Cigna are among the insurers reimbursing providers for communicating with patients via secure messaging.) Other options for compensation include a set per-patient fee paid to physicians for agreeing to coordinate care using email and other means or an annual fee paid directly by patients for email access privileges, the brief says.

Policy types “might more systematically explore whether email or other secure electronic communication with patients can deliver on its promise to enhance communication, increase patient engagement and satisfaction, improve patient outcomes and quality of care and boost efficiency,” the brief says. If email does all (or some) of that, “expanding incentives to encourage email communication between physicians and patients might be a worthwhile investment.”

"You've Got Mail - But Not From Your Doctor," Wall Street Journal (October 7, 2010).

 

Updated: Slides from Webinar on HIPAA Privacy and Security Rules

Post & Schell, in collaboration with Kroll Fraud Solutions, presented a free webinar examining the crucial changes and updates to the HIPAA Privacy and Security Rules included in the Notice of Proposed Rulemaking (NPRM) issued by the Office of Civil Rights of the U.S. Department of Health and Human Services on July 8, 2010. Post & Schell's Steve Fox and Vadim Schick highlighted the key provisions in the NPRM, including:

  • New restrictions on use and disclosure of protected health information (PHI) for marketing, fundraising, and other commercial purposes
  • Providing patients with e-copies of their PHI
  • Extension of HIPAA Privacy and Security Rules to business associates
  • Effect of new rules on business associate agreements

In addition, our guest presenter for this webinar, Alex Ricardo, CIPP of Kroll Fraud Solutions, discussed the practical implications of this new set of regulations on covered entities and business associates, including:

  • Assessing an organization's policies, procedures and practices for compliance with the HIPAA Rules and these updates
  • Reviewing current contractual agreements and relationships with business associates and their subcontractors
  • Training staff of the organization
  • Breach preparedness and breach response

You can view or download the slides from this presentation by clicking here.

For more information, contact Vadim Schick at vschick@postschell.com or 202-661-6945.

California fines hospital $250,000 for failing to comply with state breach statute

As we mentioned previously, California has the strictest data breach notification statute in the country, allowing entities only five days to report a breach, but not permitting even the customary delays  for law enforcement efforts. California Department of Public Health (CDPH) is charged with enforcement of this statute, contained in Section 1280.15 of the California Code, and may impose the maximum of $250,000 fine for each breach incident.

CDPH imposed the maximum $250,000 fine on Lucile Salter Packard Children's Hospital (LSPCH) at Stanford University for failing to report within five days a breach involving 532 patients.  The breach resulted from an employee of LSPCH stealing a laptop containing PHI for these 532 patients.

The somewhat shocking part is that CDPH levied the maximum fine on this hospital, even though the hospital reported this breach after an investigation less than two weeks later.  LSPCH discovered the breach on February 1, 2010, but did not report the breach until February 19, 2010.  In fact, CDPH learned of the breach from the hospital's notice. While a clear violation of the five-day rule (however just or draconian the rule may be), it does not seem to be an egregious violation which would merit the maximum fine. LSPCH believes that its notification to the state and to the affected individuals was reasonable and timely and is appealing the fine.

Packard Children's believes it did what it is supposed to:

The computer in question was used by an employee whose job required access to patient information. Even though the employee had signed written commitments to keep patient information confidential and secure in accordance with legal requirements and hospital policies, the hospital received reports that the now-former employee allegedly removed the computer from hospital premises and took it home. The hospital immediately began a thorough investigation and also reported the matter to law enforcement in an attempt to recover the computer quickly.

As soon as the hospital and law enforcement determined the computer was not recoverable, the hospital voluntarily reported the incident to the California Department of Public Health (CDPH) and federal authorities, as well as the families of potentially-affected patients. The hospital also provided to the families identity theft protection and other support services.

Theft charges have been filed against the former employee.

Packard Children’s believes that there has been no unauthorized or inappropriate access to the information on the computer. “We use very sophisticated tools to conduct investigations such as this,” said Ed Kopetsky, chief information officer at Packard Children’s. “We are able to detect if the missing computer connects to a network that has access to the Internet and we’ve been monitoring this activity regularly to determine if this computer has been online anywhere. It has not.”

"This theft was very unfortunate," said Susan Flanagan, RN, chief operating officer. "We hold ourselves to the highest standards in taking care of the children we treat, and we are committed to providing the best care possible and to protecting our children's privacy. The privacy and security safeguards we employ are some of the most advanced technologies and controls available to hospitals today.”

This response seems proper and reasonable.  What more could a hospital do? In California, report the breach within the required five days. But even if the hospital missed the deadline, imposing the maximum fine for the reasonable response outlined above seems too harsh.

Finally, it is worth pointing out that California is clearly determined to enforce these laws. According to Health Leaders Media, CDPH levied over $1.8 million in fines against 143 hospitals under the breach notification statute and the similar requirement for reporting wrong-site surgery or foreign objects left inside a patient.

"Hospital Fined $250,000 For Not Reporting Data Breach," Health Leaders Media (September 10, 2010).

Rite Aid settles FTC and OCR privacy charges

The Rite Aid Corporation, the third largest pharmacy chain in the United States, reached a major settlement with both the Federal Trade Commission (FTC) and HHS's Office of Civil Rights (OCR) regarding charges that Rite Aid violated federal privacy and security laws and regulations by failing to keep its customers' and employees' data safe. 

Rite Aid employees were reported to discard prescriptions and pill bottles containing sensitive patient data into the dumpsters behind various Rite Aid pharmacies, which were easily accessible to the public.  Such practices violate the HIPAA Privacy Rule, which requires covered entities to safeguard the privacy of patient information, even when such information is being destroyed.  Rite Aid's actions may also violate the company's own promises to their customers regarding keeping their health information private and secure (this broken promise being the basis for FTC's charges).

 

In addition, OCR and FTC found that Rite Aid:

  • failed to implement adequate policies and procedures to appropriately safeguard patient information during the disposal process;
  • failed to adequately train employees on how to dispose of such information properly;
  • failed to employ a reasonable process for discovering and remedying risks to personal information; and
  • did not maintain a sanctions policy for members of its workforce who failed to properly dispose of patient information.

Pursuant to their settlement with HHS, Rite Aid agreed to pay HHS a cool $1 million and agreed to implement a strong corrective action program (lasting 3 years) which includes:

  • Revising and distributing its policies and procedures regarding disposal of protected health information and sanctioning workers who do not follow them;
  • Training workforce members on these new requirements;
  • Conducting internal monitoring; and
  • Engaging a qualified, independent third-party assessor to conduct compliance reviews and render reports to HHS.

Finally, Rite Aid has also agreed to external independent assessments of its pharmacy stores’ compliance with the FTC consent order, which will be in place for 20 years.

FTC and OCR have previously filed charges against CVS Caremark, another major pharmacy chain which was reported to engage in similar violations to Rite Aid's.  

The current economic conditions require most organizations to do more with less. The unfortunate end result is that long term projects, such as major privacy and security compliance reviews and overhauls get postponed and overlooked.  Rite Aid and CVS cases should remind covered entities and other organizations responsible for keeping patient information safe that neglect or procrastination with regard to privacy policies and practices can lead to major fines, PR embarrassments and excessive compliance and legal costs. 

It is also key to remember that your organization must comply with its own privacy policies and procedures -- otherwise, FTC can charge your organization for "false promises," as was the case with Rite Aid.  In order to comply with such policies, however, your organization must train the staff about the critical importance of privacy.  Without such training, all the policies and procedures will be rendered entirely ineffective.

You can read the full OCR press release by clicking here.

You can read the full FTC press release by clicking here.

HHS issues NPRM on HIPAA Privacy, Security and Enforcement Rules

On July 7, 2010, HHS issued a notice of proposed rule making (NPRM) regarding the changes to the HIPAA Privacy, Security and Enforcement Rules, as provided in the HITECH Act, in order "to strengthen the privacy and security protections for health information and to improve the workability and effectiveness of the HIPAA Rules."  Via HHS Press Release:

The proposed modifications to the HIPAA Rules include provisions extending the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities, establishing new limitations on the use and disclosure of protected health information for marketing and fundraising purposes, prohibiting the sale of protected health information, and expanding individuals’ rights to access their information and to obtain restrictions on certain disclosures of protected health information to health plans. In addition, the proposed rule adopts provisions designed to strengthen and expand HIPAA’s enforcement provisions.

You can view the NPRM by clicking here.

"Notice of Proposed Rulemaking to Implement HITECH Act Modifications," HHS Press Release (July 7, 2010).

HealthNet and Connecticut settle breach suit

In November of 2009, health insurance provider HealthNet reported a loss of a portable disk drive (which occurred six months prior to HealthNet's report). The disk drive contained compressed, though not encrypted, data, including social security and bank account information, on nearly half a million persons.  This loss outraged the Connecticut Attorney General Richard Blumenthal, eventually leading Connecticut to file suit against the insurer for HIPAA violations and noncompliance with HealthNet's own security policies by failing to encrypt the sensitive data.

However, on July 6, 2010, Blumenthal (who is currently running to replace Chris Dodd (D-CT) in the U.S. Senate) announced that Connecticut has reached a settlement with HealthNet and its parent companies over this breach.  According to Blumenthal, this is the very first time a state Attorney General reached such a settlement for a HIPAA violation. The settlement included:

  • $250,000 fine to be paid to Connecticut;
  • $500,000 contingency fund, to be paid to the state in the event it is determined that someone accessed the protected data on the lost disks; and
  • a "corrective action plan" which is aimed to enhance security of protected data in possession of HealthNet and its parent companies.

It is important to keep in mind that the penalties could have been even higher. Yet regardless of the amount of the fine, this breach cost much more to HealthNet than $250,000.  The costs associated with investigations, breach notification, and possible legal fees almost certainly cost the organization more than the amount of the fine imposed by Connecticut.  Thus, HealthNet's example should serve as a great reminder about the importance of doing everything possible to avoid a breach, and knowing how to handle a breach effectively if one does occur.

"Blumenthal wins $250,000 in Health Net settlement," TheDay.com (July 6, 2010).

California hospital breached patient privacy by faxing records to a wrong number

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).

Updated: breaches and fines on the rise

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.

In the first instance,

an unidentified radiology technician accessed 204 records for 177 patients between Jan. 10, 2009, and Feb. 22, 2009, without having a clinical reason to do so. The investigation report doesn't indicate whether the employee used the information she got or contacted the patients.

In a second investigation, inspectors found that a medical imaging department employee allowed a friend who was visiting her into a restricted access room where the employee worked. The visitor could overhear patients discuss their personal information with the employee, a report states.

This should serve as an important reminder about the far-reaching nature of medical information privacy laws -- both federal and local.  California has a particularly strict medical privacy law, enacted in 2008.  Breach does not mean just a lost laptop, hacking or intentional access of a celebrity's records, as we saw last year in California.  It could be a wide range of activities, and hospitals and other providers should pay close attention to the fast-changing regulatory environment, create or modify their policies and procedures accordingly and, perhaps even more crucially, train their staff to comply with such necessary policies and procedures.

"Missing records on stolen laptop from Cincinnati Children's Hospital," Cincinnati.com (May 28, 2010).

"SB hospital fined $325,000 for breach of patient records," Press-Enterprise (June 10, 2010).

"Large Patient Information Breaches List Nears Century Mark," Health Leaders Media (June 16, 2010).

Facebook's privacy struggles

The Wall Street Journal devoted the front page of its "Marketplace" section to a report on Facebook's struggles with privacy advocates, regulators like FTC, and, at times, even its own employees.

The company can't afford not to act. The Federal Trade Commission is taking a close look at how online social networks are using people's data, and people close to the matter say it is increasingly focused on Facebook. <...>

A group of senators led by Sen. Charles Schumer (D., N.Y.) called on Facebook to roll back the changes and more than a dozen privacy groups lodged a complaint with the FTC on grounds that Facebook was displaying user information without their consent.

Facebook faces a herculean task of keeping personal information of its 500 million subscribers private and secure.  Privacy is a major stumbling block for this young company, which hopes to earn billions in ad revenues by using the private data it collects from its subscribers. 

Facebook must clearly articulate to its subscribers the privacy risks and security settings available to them; but, ultimately -- as the clever someecard, above, suggests -- the best way to ensure the privacy of one's personal information is not to share it with the world, via Facebook or any other online social networking site.

"Facebook Grapples With Privacy Issues,"  Wall Street Journal (May 19, 2010).

Prison sentence for hospital employee who breached patient privacy

Back in January, we wrote about Huping Zhou, a former employee at the UCLA Healthcare System, who pleaded guilty to federal charges of breaches of patient privacy.  Zhou, 48, accessed the UCLA patient records system 323 times during the three-week period, mostly looking for the files of celebrities, after being let go by the hospital. Names of targeted celebrities have not been revealed.

On April 27, 2010, Zhou was sentenced to four months in prison after pleading guilty to four misdemeanor counts of HIPAA violations. Zhou is the first person ever sentenced to prison for violating HIPAA.  According to NBC Los Angeles:

Federal officials say Zhou is a licensed cardiothoracic surgeon in China. In 2003, he went to work for UCLA as a researcher with the UCLA School of Medicine. But his tenure was short and stormy. School officials notified him that he would be dismissed in October that year, and that's when federal officials say the snooping began.

In his plea agreement, Zhou admitted his actions, and that he had no legitimate reason for accessing the records. Federal authorities say there's no evidence that he did it for profit. Apparently, he just did it because he could.

"Former UCLA Healthcare Worker Sentenced to Prison for Snooping, " NBC Los Angeles (April 28, 2010).

Connecticut radiologist breaches privacy of hundreds

HealthImaging.com reported yesterday that a Connecticut radiologist, previously affiliated with the Griffin Hospital in Derby, Conn. "accessed patient radiology reports on the hospital's PACS using the passwords of other radiologists and an employee within the radiology department. The passwords were obtained and/or used without their knowledge." From HealthImaging.com:

From the investigation conducted by Griffin, it appears the radiologist who gained unauthorized access scanned the PACS directory listings of 957 patients who had radiology studies performed at Griffin during the period and selected and downloaded the image files of 339 of these patients.

On and after Feb. 26, Griffin received inquiries on behalf of patients regarding unsolicited contact by the physician who offered to perform professional services at another area hospital despite the patients' interest in having those services provided at Griffin. The inquiries prompted the investigation that revealed unauthorized intrusions into Griffin's PACS and, thereby, the breach of protected patient health information.

This should serve as a reminder for healthcare providers regarding maintaining the safeguards necessary to prevent wrongful access to patient data.  For example, and there is no indication that this is what occurred in this case, clinicians and other hospital staff should not keep their system passwords on sticky notes next to or on their monitors.  Even if you believe that everyone in your office is fully trustworthy, you never know who can get a hold of such restricted information as usernames and passwords.  The reputational and financial damage to your organization could be very substantial; and your contract with the PACS system vendor is unlikely to indemnify or protect you from such losses.

"Radiologist breaches data, images of nearly 1,000 patients via PACS," HealthImaging.com (March 31, 2010).

ONC publishes white paper on consent options

The Office of National Coordinator for Health IT (ONC) published on its web site a white paper analyzing the policies behind obtaining consent for the purposes of electronic health information exchange.  The paper examined the concept of patient control of their health information, focusing on "the issues, nuanced considerations, and possible tradeoffs associated with the various consent options to help facilitate informed decision making."  While the paper was written by researchers at the George Washington University, under contract with ONC, ONC clearly stated in the preamble that this white paper does not actually represent the views of the ONC or HHS.

You can find the full paper (and the attachments) by clicking here.  You can view the executive summary by clicking here.

In the news: medical ID theft on the rise; CHIME comments on meaningful; and more

  • Javelin Strategy & Research survey found over 275,000 cases of medical identity theft in 2009, with an average price tag greater than $12,000 per incident.  This is twice as many cases as in 2008.  Keeping health information safe is going to be of paramount importance in the next decade, especially considering the steep rise in use of electronic health records. According to Computerworld.com (citing a study by IDC, a research firm), "about a quarter of all Americans -- 77 million people -- already have an EHR, up from 14% from in 2009." By 2015, experts believe the number will reach up to 60%, partially due to the transformation of the health IT industry by the HITECH Act.
  • In its comments to CMS regarding the meaningful use NPRM, College of Healthcare Information Management Executives (CHIME) insisted that the present "all or nothing" approach to achieving meaningful use is going to prevent significant numbers of eligible providers from receiving any incentive payments under the HITECH Act.  According to American Medical News:

Among CHIME's suggestions: a gradual implementation process that would allow physicians to qualify for incentives by achieving 25% of meaningful use objectives by 2011, 50% by 2013, 75% by 2015, and 100% by 2017.

'Without an approach that rewards progress or provides sufficient time, organizations with limited resources will likely have little chance of qualifying for payments, thus widening the 'digital divide' in the country,' CHIME wrote.

  • U.S. Senate passed a bill which, if approved by the House and signed by the President, would limit the definition of "hospital-based" eligible professionals to just those practicing in an inpatient or emergency room hospital setting.  If passed, this change would make the Medicare and Medicaid EHR incentive payments available to a far wider range of eligible professionals.
  • CCHIT may be getting some competition from the Drummond Group, which announced plans to become an ONC-authorized certifying body of EHR technology (ONC-ATCB).

"U.S. Senate backs expanded physician eligibility for MU," HealthImaging.com (March 11, 2010).

"Drummond Group in EHR testing for the 'long term'," Healthcare IT News (March 12, 2010).

"Patient Billed for Liposuction as Medical Theft Rises," Bloomberg.com (March 23, 2010).

"As health data goes digital, security risks grow," Computerworld.com (March 22, 2010).

"EMR meaningful use rules warrant gradual approach," American Medical News (March 17, 2010).

Rising numbers and costs of data breaches

There is little doubt that the healthcare industry must prepare for a growing number of - and expanding costs associated with - data breaches, particularly for breaches of protected health information.  Here are just a few notable reports on this subject:

  • Infosecurity.com reported on a striking increase in attempts to hack into healthcare organizations, while the rate of hacking in other economic sectors remained flat:  "the last quarter of [2009] saw an average of 13 400 attempts to hack healthcare organizations, compared to an average of 6,500 in the first nine months."  According to researchers at SecureWorks, which produced the graph above, healthcare organizations are particularly vulnerable to such attacks because they "have to provide access to many external networks and web applications so as to stay connected with their patients, employees, insurers and business partners. This increases their risk to cyber attacks."
  • Cnet News reported on similar findings by the Ponemon Institute, whose survey concluded that "Data breaches at U.S. companies attributed to malicious attacks and botnets doubled from 2008 to 2009 and cost substantially more than breaches caused by human negligence or system glitches."  The cost per compromised record involving a criminal act averaged $215, about 40% higher than breaches from negligence and 30% higher than those from glitches, the Ponemon survey found.

 

There are also a couple of examples of individual healthcare organizations suffering from increasing costs associated with data breaches:
 

  • According to Chattanooga Times Free Press (via iHealthBeat), BlueCross BlueShield of Tennessee announced that it has spent more than $7 million to respond to a security breach resulting from 57 hard drives having been stolen from its training facility, which may have compromised personal and health data of up to 500,000 members.  $7 million tab does not appear to be the end of it:

The insurer has notified 220,000 BlueCross members about the data theft. The company also is offering no-cost credit-monitoring services for affected members. In addition, BlueCross is working to notify attorneys general in 32 states about the breach [pursuant to the HITECH Act].   <...>

BlueCross officials said 20,500 members already have signed up for the no-cost credit-monitoring services. In addition, the company has hired more than 700 contract and BlueCross employees to help determine what data the hard drives contained. The insurer said it might need to spend significantly more money to evaluate the missing data and provide additional identity protection services.

  • Considering the experience of BCBS of Tennessee, the costs associated with HealthNet's infamous data breach must be even higher. On top of providing two years of free credit-monitoring for hundreds of thousands of affected members, HealthNet is being sued by the state of Connecticut for HIPAA violations and noncompliance with HealthNet's own security policies by failing to encrypt the sensitive data.  The missing hard drive contained "27.7 million scanned pages of more than 120 different types of documents, including insurance claim forms, membership forms, appeals and grievances, correspondence and medical records."  Further complicating HealthNet's situation is the fact that the company waited for six months to inform the affected customers of the possible breach.

"Healthcare hacks on the rise," Inforsecurity.com (January 26, 2010).

"Survey: Data breaches from malicious attacks doubled last year," cnet News (January 25, 2010).

"Tab for Response to Data Breach Hits $7 Million for BCBS of Tennessee," IHealthBeat (January 26, 2010).

"AG files suit in health data privacy breach," theday.com (January 13, 2010).

 

 

CBS News reports on EHR efforts

By popular demand, here is the video of David Pogue's report on the Obama Administration's efforts to digitize patient records in the U.S. 


Watch CBS News Videos Online

"Charting a New Course," CBS News (September 13, 2009).

New York Times interviews David Blumenthal

David Pogue, a reporter for the New York Times, posted the transcript of his interview with Dr. David Blumenthal, National Coordinator for Health IT. Mr. Pogue interviewed Dr. Blumenthal for a CBS news report on digitization of healthcare in America (the video is available after the jump).

Here are some highlights from the interview:

On current state of health IT in the US:

We found that about 17 percent of physicians in 2008 had adopted an electronic health record, and about ten percent of hospitals. <...> The rest is paper. It's basically the same system that physicians have used since Hippocrates, which is writing on some piece of paper.

On reimbursement penalties for those failing to achieve meaningful use by 2015:

From 2011 to 2015, there is a bonus. The Congress has put $45 billion on the table to ease physicians and hospitals into this new world of computerized medicine.After 2015, if you have not adopted, and you see Medicare or Medicaid patients, you may experience a penalty. 2015 is six years off. Six years is plenty of time for physicians to get themselves organized to put a record in place and avoid those penalties.

 

On cost of EMRs:

On average, the cost is between $40,000 and $50,000, of which about a third is the software and the hardware, about a third is the cost of getting it set up in the office, and about a third is maintaining it. Much of the expense is related to the cost of implementing and the cost of maintaining it over time.

On privacy and security:

Privacy and security are foundational to a modern health information system. You cannot get the computer into this business without assuring people that their information, their personal information, will be safe.

So we are looking at the best possible technical solutions, technical protections, to privacy and security. We want to make sure that we have looked at every opportunity for encryption, every security device that the best minds can think of, to make information safer. We've got it in other parts of the industry, but we don't have it for healthcare. So I think that's a very important agenda item for us.

<...>

There are two kinds of anxieties. One is that their data may be used for purposes that they haven't authorized it. So if they haven't authorized their personal data to be used for research, they don't want it for that purpose. And the way the law gets around that problem is by saying that information should be de-identified; that is, it should be abstracted from the record in a way that can never be traced back to that individual.

And then that information can be used for research on drug safety, or research on the value of particular treatments, or anything els that may be useful to human health.

There's another kind of fear, and that is the fear of the breach or break-in, or hacking. And there have been some examples of that.

That's where better encryption and better barriers to hacking are critical. And, you know, we have a new cybersecurity initiative that President Obama has put in process. It's well known that the security of information is a national need for defense purposes. It's also, I think, a very important need for this domestic policy purpose. So we want to work with that security initiative to know that we've taken advantage of everything that the federal government and the computer industry knows about how to keep records secure.

Finally, the big picture:

Well, it's a big challenge, it's an exciting challenge, and a historic challenge. There's nothing that's worth doing that's easy to do in life, and this is one of those.

But I really think that history is on the side of this activity. To be a 21st-century physician, to be a 21st-century hospital, we can't record data the same way the Greeks did in 500 B.C. We've gotta move to use the computer to support our work. And that's what we're trying to do.

There'll be bumps on the road. We're not gonna be perfect. We'll make mistakes. But I think the wind is at our back in terms of the historical trends. And we'll get there, sooner or later.

"Computerized Health Records," New York Times (October 15, 2009).

"Charting a New Course," CBS News (September 13, 2009).

 


Watch CBS News Videos Online

HIT Standards Committee endorses privacy and security standards

On September 15, 2009, the HIT Standards Committee endorsed a set of privacy and security standards for electronic health record systems. 
These standards will be recommended to Dr. David Blumenthal, the National Coordinator for Health Information Technology, as a basis for establishing the privacy and security criteria for, inter alia, "certified EHR technology" as defined under the HITECH Act.  Eligible healthcare providers must meet the criteria for "meaningful use" of "certified EHR technology" in order to qualify for significant incentives available under the HITECH Act.

The committee’s Privacy and Security Workgroup included access control, authentication, authorization and transmission of health data among the requirements that electronic health record systems must include by 2011 in order to meet the definition of "certified EHR technology."   Specifically for 2011, the Standards Committee approved the Workgroup's recommendation to require certified products to provide the capabilities necessary to support the HIPAA and ARRA security and privacy requirements and best practices for “meaningful use.”  The endorsed privacy and security standards will become more rigorous in 2013 and 2015.

You can find the spreadsheet of endorsed privacy and security standards here.

You can also view the presentation from the Workgroup here.

"Federal panel okays EHR security, privacy standards," Government Health IT (September 15, 2009).

 

 

FTC Issues Final Breach Notification Rule for Electronic Health Information

Pursuant to the American Recovery and Reinvestment Act of 2009 (ARRA), the Federal Trade Commission (FTC) issued the final rule regarding notification requirements for breaches of electronic health information by vendors of personal health records and certain affiliated entities:

The rule applies to both vendors of personal health records – which provide online repositories that people can use to keep track of their health information – and entities that offer third-party applications for personal health records. These applications could include, for example, devices such as blood pressure cuffs or pedometers whose readings consumers can upload into their personal health records. Consumers may benefit by using these innovations, but only if they are confident that their health information is secure and confidential.

<...>

The Final Rule requires vendors of personal health records and related entities to notify consumers following a breach involving unsecured information. In addition, if a service provider to one of these entities has a breach, it must notify the entity, which in turn must notify consumers. The Final Rule also specifies the timing, method, and content of notification, and in the case of certain breaches involving 500 or more people, requires notice to the media. Entities covered by the rule must notify the FTC, and they may use a standard form, which can be found along with additional information about the rule at www.ftc.gov/healthbreach.

You can find the full text of the rule here.

"FTC Issues Final Breach Notification Rule for Electronic Health Information," FTC Press Release (August 17, 2009).

Healthcare providers must become aware of and comply with PCI DSS

Healthcare providers are generally familiar with and are used to the complex network of state and federal data privacy protection laws (e.g., HIPAA and HIPAA Privacy and Security regulations).  However, most providers may not be aware of another set of data security standards, the Payment Card Industry Data Security Standards (PCI DSS), imposed by a non-governmental, private organization representing the credit card industry.  

Contrary to popular belief, PCI standards apply to any processor of credit cards, regardless of volume of credit card transactions.  (However, PCI DSS differ based on each organization's transactions volume.)  In other words, if your healthcare enterprise or practice accepts credit cards as payment for services (which virtually all practices do), your organization is subject to PCI DSS.  

SC Magazine's recent contribution from Jim Lacy, CFO of healthcare IT company ZirMed, provides an excellent reminder for all healthcare providers accepting credit cards to take note of PCI DSS and begin the process of compliance with such standards.

A few lessons from Jim Lacy's piece and more after the jump.

Jim Lacy reminds healthcare providers of a few basic principles of PCI compliance:

  • As mentioned above, PCI DSS applies to all entities processing credit card transactions, regardless of volume.
  • PCI DSS compliance is not prohibitively expensive.  Certain PCI-compliance services are available online for as little as $150 a year.
  • If your organization is not compliant with PCI DSS, you may not be able to process credit card transactions in certain markets.
  • Aside from suspension of one's ability to process credit card transactions, a data breach for non-compliant providers may cost hundreds of thousands of dollars in fines alone (VISA can impose fines up to $500,000 per incident).
  • HIPAA compliance does not mean compliance with PCI DSS.

In addition to PCI DSS, at least one state, Minnesota, adopted most provisions of PCI DSS prohibiting storage of credit card data as state law, the Plastic Card Security Act (PCSA).  PCSA essentially created a strict liability standard for entities processing over 20,000 credit card transactions a year for any losses or damages caused by a data breach of stored credit card data. 

Thus, a Minnesota healthcare enterprise may be strictly liable to credit card companies or patients for losses or damages resulting from a security breach of stored credit card data, if such provider was not compliant with PCI DSS and the applicable provisions of Minnesota law.

"PCI-DSS: Not on health care provider's radar", SC Magazine (June 19, 2009).

 

New York Times reports on the growing threat of medical identity theft

The New York Times reported today on the growing threat posed to patients and consumers by medical identity theft.  The article rightfully notes that this threat may only become more prominent with the widespread adoption of electronic health records technology championed by the Obama Administration. 

According to the Times, over 250,000 Americans are victims of medical identity theft each year, and this number does not include those who are not yet aware that they are victims of such identity theft.  The article profiled one case of medical identity theft, that of Brandon Sharp, a 37-year-old manager at an oil and gas company in Houston:

In Mr. Sharp’s case, someone got hold of his name and Social Security number and used them to receive emergency medical services, which many hospitals are obliged to provide whether or not a person has insurance. Mr. Sharp still does not know whether he fell victim to one calamitous perp who ended up in several emergency rooms or a ring of accident-prone conspirators.

 

The article continued:

In another variant of the crime, someone can use stolen insurance information, like the basic member ID and group policy number found on insurance cards, to impersonate you — and receive everything from a routine physical to major surgery under your coverage. This is surprisingly easy to do, because many doctors and hospitals do not ask for identification beyond insurance information.

Even more common, however, are cases where medical information is stolen by insiders at a medical office. Thieves download vital personal insurance data and related information from the operation’s computerized medical records, then sell it on the black market or use it themselves to make fraudulent billing claims.

The new privacy and security regulations included in the HITECH Act are aimed at increasing protections for privacy of patient information (e.g., new accounting and reporting rules, as well as rules regarding access and accuracy of a patient's record.)  HHS has yet to provide some regulation around such privacy and security requirements. 

Finally, the Federal Trade Commission's "Red Flags Rule" is aimed at preventing medical identity theft.  In fact, one of FTC's suggestions to healthcare organizations for identity theft prevention is to institute a practice of checking patients' ID before providing services to such patients.

"Your Medical Problems Could Include Identity Theft", New York Times (June 12, 2009).

 

Sears settles FTC claims regarding its online tracking software

On June 4, 2009, Sears Holdings Corporation (Sears) settled its dispute with the Federal Trade Commission (FTC) regarding Sears's controversial online tracking software.  Sears paid its customers $10 to join "My SHC community" and download  software which would track participants' online behavior.  However, FTC alleged that Sears did not adequately disclose the enormous scope of information Sears collected on the participants:

<...> Sears represented to consumers that the software would track their “online browsing.” The FTC charges that the software would also monitor consumers’ online secure sessions – including sessions on third parties’ Web sites – and collect information transmitted in those sessions, such as the contents of shopping carts, online bank statements, drug prescription records, video rental records, library borrowing histories, and the sender, recipient, subject, and size for web-based e-mails. The software would also track some computer activities that were not related to the Internet.

Sears did disclose the full extent of what information it would monitor, but only "in a lengthy user license agreement, available to consumers at the end of a multi-step registration process", which the FTC deemed to be inadequate. 

Under the settlement, Sears is required to destroy the data collected under this program, and to "clearly and prominently disclose the types of data the software will monitor, record, or transmit" if Sears advertises or disseminates any tracking software in the future.  The FTC also required Sears to make such disclosure prior to installation of the software and separate from any user license agreement; and disclose whether any of the data will be used by a third party.

"Sears Settles FTC Charges Regarding Tracking Software", FTC press release (June 4, 2009).
"Sears settles with FTC in privacy flap", Reuters (June 4, 2009).

Steve Fox on the ARRA privacy requirements

In an interview with Thompson's Compliance Information Center, Steve Fox urged healthcare providers to begin the compliance process to meet the new data privacy and security requirements imposed under the American Recovery and Reinvestment Act of 2009: 

“The main message for providers is that ARRA is not something they can wait until next year for,” said Steven J. Fox, Esq., a partner at the law firm Post & Schell in Washington D.C. and co-author of the Guide to Medical Privacy & HIPAA.  Although Fox does not advise covered entities to completely overhaul their HIPAA compliance programs before HHS issues regulations, he does say they should begin reviewing all of their current privacy and security policies and procedures and comparing them with the new ARRA requirements. Entities should conduct “a thorough self analysis to determine where they stand.

Covered entities also should train their staff so they understand the importance of privacy and security. Under ARRA’s new penalty provisions, there is an increased potential of significant fines being levied, so entities should prepare by readying their staff for new requirements.

“People need to be trained and retrained to understand how their jobs are changing” as a result of the ARRA privacy and security provisions, Fox said. But, he cautioned “it is premature to do an overhaul of training programs” right away. “Someone needs to revise the whole compliance training program to include all of the ARRA changes — but not too far in advance before the changes are required,” he said.

This interview also headlined IAPP's Daily Dashboard briefing on April 16, 2009.

 

Deloitte Publishes Healthcare Consumer Survey Findings

Deloitte published the results of its 2009 survey of more than 4,000 healthcare consumers, and the findings included some good news for the healthcare IT industry:

  • 9% of consumers have an electronic personal health record (PHR), but 42% are interested in creating one connected online to their physicians.  This leaves much room for growth for companies like Microsoft and Google which offer a PHR product.
     
  • 55% want the ability to communicate with their doctor via email to exchange health information and get answers to questions, and 57% would be interested in scheduling appointments, buying prescriptions and completing other transactions online if their information is protected.
  • 4 in 10 favor increasing government funding and incentives to support adoption of electronic medical records by doctors, hospitals and health plans.

However, consumers remain worried about the privacy and security of their personal health information, with 38% of those surveyed being "very concerned" as opposed to 24% of those who are not concerned at all.  Sixty percent support government establishing standards "for how medical for how medical information is collected, stored, exchanged and protected." 

The full survey findings can be downloaded here.

"Deloitte Survey Finds Healthy Consumer Demand For Electronic Health Records, Online Tools and Services", PRNewswire.com, April 6, 2009.

"2009 Survey of Health Care Consumers: Key Findings, Strategic Implications", Deloitte Center for Health Solutions, released April 2009.

In the news: CVS and Google; Connect Open Source Software; and more

  • CVS pharmacy customers now have the ability to download their prescription and medication histories to Google Health accounts after CVS and Google expanded their partnership.  Patients at CVS' walk-in MinuteClinics are also able to add summaries of their visits to their Google Health accounts.  It would be interesting to find out if CVS and Google ever executed a Business Associate Agreement.  After the enactment of the HITECH Act, Google famously maintained that its personal health records product is not a subject to the new legislation and certain privacy and security provisions under HIPAA.  ("CVS-Google Health pact now includes drugstores", AP, April 6, 2009.)
  • The federal government released Connect, and open source software which allows public and private entities to share health information via the National Health Information Network.  The source code is free to download (the code and its documentation are available here), but organizations choosing to acquire and use this product will be responsible for costs associated with the installation and maintenance of Connect.  The Social Security Administration, Department of Defense, Veterans Affairs, and the CDC are among the many government agencies using this software for health information exchange already.  ("NHIN software released to open-source community", Government Health IT, April 7, 2009.)

     

 

  • This Business Week article analyzes the various data privacy and security concerns facing health care providers and patients alike.  ("Putting Patient Privacy in Peril?", Business Week, April 6, 2009.)
  • The New York Times reports that New York-Presbyterian Hospital became "the first large institution to move beyond the pilot stage this week as it begins to offer consumer-controlled health records for patients... New York-Presbyterian has been working with Microsoft for more than a year, not only on technical matters but also ease-of-use concerns with patients. The introduction will be gradual, beginning with heart patients, who will be told of the potential benefits of personal health records when they visit a New York-Presbyterian hospital or outpatient clinics."  Once again, it would be very interesting to find out if NYB and Microsoft signed a Business Associate Agreement, or if Microsoft acknowledged whether it is now subject to certain privacy and security provisions under HIPAA.  ("A Hospital Is Offering Digital Records", New York Times, April 5, 2009.)

 

Risk Prevention/Management Advice to Hospitals Regarding Document-Sharing Technology

Hospitals, multi-hospital systems, and integrated healthcare delivery systems are increasingly utilizing data-sharing technology to communicate with, and share documents among, their officers and directors. 

For example, some healthcare business enterprises use online services to upload documents to a “secure” Internet web site for Board members’ review prior to Board meetings, in lieu of sending out such documents via e-mail or in paper form. Healthcare business enterprises using such services need to be aware of many potential security and privacy risks inherent in transmitting, uploading and storing sensitive, confidential or even proprietary information via the Internet.

 

 

Communications to a hospital Board may include:

  • Confidential information regarding the hospital’s operations or personnel;
  • Data on non-public commercial and financial affairs of the hospital;
  • Legally privileged information regarding law suits on behalf of or against the hospital; and
  • Confidential and privileged peer review materials, including protected health information (PHI, as defined under HIPAA) of the hospital’s patients.

Prior to acquiring or using such data-sharing technology, healthcare business enterprises should make sure that the software is secure and that both the enterprise and the service provider use appropriate physical and technical security safeguards to protect personal and otherwise protected information. There is no one fail-safe approach to implementation and operation of data-sharing technology, and such technology should be customized to fit the enterprise’s needs and requirements. However, at minimum, preliminary precautions should include:

  • Knowing exactly what information is being distributed, via what channels (e.g., whether it is contained on a laptop, another portable device or on the network);
  • Avoiding access, storage, sharing, or use (including downloading, printing, or emailing) of information from or via unsecured home office computers or other mobile devices;
  • As much as possible, limiting the unencrypted sensitive data being transmitted;
  • Avoiding use of actual personal or confidential data in testing of the software;
  • Implementing access control checks, including restricting access to essential personnel only;
  • Using intrusion detection technology or procedures to quickly detect any unauthorized access; and
  • Training and educating all relevant personnel and all persons with access to such information regarding the enterprise’s data privacy protection policies and procedures.

In order to protect your healthcare business enterprise, your Legal and IT teams should negotiate an agreement with the service provider which, at minimum, includes the following provisions:

  • A warranty from the service provider that their product is safe, secure, and complies with all applicable privacy and security standards; 
  • A requirement for the software provider to comply with your institutional privacy and security policies, as well as all applicable laws and regulations;
  • An explicit prohibition for the service provider to use, communicate, divulge, exploit, duplicate, distribute, publish, reproduce, transfer, dispose of, recreate, modify, or create derivative works based upon or otherwise reveal or make available to any third party, directly or indirectly, for any purpose, except as provided in such contract; and
  • Indemnification, remedies, limitation of liability, and other provisions protecting your business enterprise for any damages resulting from a data breach or loss, in instances where such breach or loss are caused by the purchased software or the service provider.

Finally, the agreement with the service provider should include a Business Associate Agreement (BAA, as defined under HIPAA); however, please keep in mind that the BAA should acknowledge the changes mandated by the recent American Recovery and Reinvestment Act of 2009, as well as numerous new regulations to be promulgated by the Secretary of Health and Human Services under this Act.