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Industry Insiders Discuss HIT and HIPAA Issues March 30, 2009 by Astrid Fiano, Writer A significant part of President Obama's health care reform agenda is the push for implementing more health care technology. In the health care field privacy is always a major concern, and was the impetus of the Health Insurance Portability and Accountability Act of 1996--protecting the privacy of individually identifiable health information in all formats, and the confidentiality provisions of the Patient Safety Act--protecting identifiable information being used to analyze patient safety events. So those in the health care industry now wonder will the Administration's focus on health IT (HIT) present more challenges to privacy concerns? As part of a continuing focus on HIT issues, DOTmed interviewed industry expert Kirk J. Nahra, a partner in the Washington D.C. legal firm of Wiley Rein LLP, specializing in privacy and information security for the health care and insurance industries, and named an expert practitioner by the Guide to the Leading U.S. Healthcare Lawyers. DOTmed also interviewed Lise Rauzi, Vice President, Training Development, for Health Care Compliance Strategies (HCCS). HCCS provides online training compliance for employees. Nahra notes that regardless of the rising concern over privacy and the new HIT legislation, there have already been formal HIPAA security rules on electronic information in place for several years--the health care industry compliance has just been inconsistent. The problem -- to the extent there is one -- is that HIPAA rules are process-oriented, Nahra explained. The rules don't tell an entity what to do, but rather what to evaluate--a standard set of questions, but without a standard set of answers. For example, a covered entity has to have an internal audit, but the rules do not tell the entity how best to carry out that internal audit. Not surprisingly, different businesses have different ideas on how to implement their HIPAA evaluations

Congress has been dithering over the adoption of a federal data security breach notice law for the last several years without coming to an agreement on a national standard for reporting breaches in the security of personal and financial data, but on February 17, data breach notice provisions applicable to health information were signed into law as part of the HITECH Act provisions of the massive economic stimulus legislation, H.R. 1 (111th Cong., 1st Sess. Feb. 17, 2009). Beginning no later than September 16 of this year, "covered entities" under the Health Insurance Portability and Accountability Act (HIPAA) will be required to give notice of breaches in the security of protected health information, and "business associates" of HIPAA-covered entities will be required to report such breaches to the covered entities. §13402(a) & (b). Currently, California and Arkansas are the only states that require that notification be given in the case of a breach in the security of medical or health insurance information. The HIPAA Privacy Rule currently does not contain a requirement that individuals be notified in the event of such as breach. However, some covered entities interpret the existing HIPAA Privacy Rule requirement that covered entities mitigate harmful effects of uses or disclosures of health information in violation of either the Privacy Rule or the entity's policies and procedures as suggesting that such notice be given, and many covered entities currently provide such notification.

"HIPAA was never intended for the digital age, because the 1996 HIPAA law never anticipated the emergence of Web-based records." -- David Brailer, former national coordinator for Health Information Technology "Before increasing federal spending on health IT, Congress should first fix the already-outdated 1996 HIPAA privacy rule to ensure individuals have control over their personal health information," said Sue A. Blevins, president of the Institute for Health Freedom (IHF). "Right now, the HIPAA privacy rule has too many loopholes to ensure true patient privacy."

"In a sign that state attorneys general may be flexing the HIPAA enforcement muscle granted by the HITECH Act provisions in the Recovery Act, the Connecticut and Arizona attorneys general are investigating health plans that recently experienced data breaches that they failed to disclose for several months. Typically, state attorneys general prosecute only violations of state laws, but they now have authority to investigate and levy fines for violations of HIPAA and the HITECH Act, which requires mandatory notifications within two months of knowledge of a breach. Connecticut Attorney General Richard Blumenthal (D) has emerged as possibly the first AG to take on a HIPAA investigation, and Arizona's AG may also be pursuing a similar course. The larger of the two breaches that have come to the AGs' attention was experienced by Health Net, Inc., which lost a portable external hard drive containing seven years of data for 446,000 Connecticut residents. The lost data came from 1.5 million individuals in total, who also hailed from New Jersey and New York. Health Net reported the loss to the Connecticut AG on Nov. 19, and on the same day Blumenthal issued a scathing statement demanding answers and promising action. He specifically said he was investigating whether Health Net may have violated "federal laws," as well as his state's own data protection laws."

URAC, the leading health care accreditation and education organization, announced today the recent Healthcare Information and Management Systems Society (HIMSS) annual conference raised important questions about consumer privacy and security around electronic health records (EHR). (Logo: http://www.newscom.com/cgi-bin/prnh/20030501/URACLOGO ) "There is no doubt that electronic health records are coming. The question is whether or not consumers' privacy is a key issue or an afterthought," said Alan P. Spielman, President and CEO of URAC. "A lot of forces are driving the push for EHR. However, it is important that standards go hand-in-hand with policy so that it doesn't become the Wild West with every vendor and health care provider using different terms." The rules set by the Health Insurance Portability and Accountability Act (HIPAA) are integral to the widespread adoption of EHR. However, the rules can be confusing for consumers and providers. URAC was the first organization to offer HIPAA Privacy Accreditation. The organization now offers comprehensive standards for both HIPAA Privacy and HIPAA Security accreditation. These standards are applicable to all personal health information storage formats and exchanges claims transactions and are designed for many different types of health care organizations including both Covered Entities (CE) and Business Associates (BA). They also require an ongoing compliance program that identifies, tracks and makes the necessary changes in response to a federal or state regulatory change.

A rule requiring healthcare providers, health plans, and other entities covered by the Health Insurance Portability and Accountability Act (HIPAA) to notify individuals of a breach of their unsecured protected health information will become effective September 23, 2009. The "breach notification" regulations implement provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act of 2009 (ARRA). The new "breach notification" regulations apply to HIPAA-covered entities and their business associates. HIPAA covered-entities include health plans, healthcare clearinghouses, and healthcare providers. A business associate is a person or entity (such as a healthcare benefits broker) who, on behalf of the covered entity, performs a function involving the use or disclosure of individually identifiable health information.

Current government rules do too little to protect the privacy of people's personal health information and also hinder the use of health data in medical research, a panel of experts reported on Wednesday. A committee of the Institute of Medicine, which provides advice to U.S. policymakers, urged Congress to take an entirely new approach to protecting personal health data in research. Federal standards for protecting privacy of personal health data under the Health Insurance Portability and Accountability Act of 1996, or HIPAA, are not doing the job, the panel said. Congress and the Obama administration are planning major changes this year to the U.S. health care system. Regarding the privacy rules, Congress should either start from scratch or thoroughly overall HIPAA's privacy provisions, the panel said. Better data security is needed, with greater use of encryption and other security techniques, the panel said. Encryption should be required for laptops, flash drives and other devices containing such data, it said. "Both privacy and health research are important. And we feel that we can strengthen privacy protections for people who participate in research while also allowing important research to proceed without unnecessary impediments," Dr. Bernard Lo of the University of California San Francisco, a member of the panel, told reporters. HIPAA governs how personally identifiable health information can be used and disclosed by health plans, health care providers and others. The intention is to protect personal health information while permitting the flow of information for health-related research and medical care. Lo said HIPAA has burdensome and confusing procedures for people to consent to have their health data used in medical research, dissuading people from taking part in such research.

"The U.S. Department of Health and Human Services issued an interim final rule to beef up penalties for violations of the Health Insurance Portability and Accounting Act (HIPAA), as several Congressmen criticize the agency for leaving dangerous loopholes in the law. The new rules significantly increase penalty amounts that the U.S. Department of Health and Human Services can impose for HIPAA violations of patient privacy, according to a statement from HHS. The new rules reflect requirements enacted in the Health Information Technology for Economic and Clinical Health (HITECH) sections of the American Recovery and Reinvestment Act (ARRA) of 2009. Before HITECH, maximum penalties were $100 for each violation or $25,000 for all identical violations of the same provision. A covered health care provider, health plan, or clearinghouse could be exempt from civil financial penalties if it demonstrated it did not know it violated the HIPAA rule. The HITECH act increases civil financial penalties by establishing tiered ranges of increasing minimum penalties, with a maximum $1.5 million for all violations of identical provisions. And a "covered entity" can plead ignorance as a protection only if it fixes the violation within 30 days of discovery."

The US government has now adopted a policy of fostering the adoption of electronic medical records (EMR). The policy is intended to increase the efficiency of the US healthcare system, thereby lowering costs and reducing the incidence of preventable errors. At the same time, through its The Health Insurance Portability and Accountability Act (HIPAA) privacy rules, the government has set minimum standards for the security of those records. These two goals-privacy and security of these records, along with their free interchange among medical providers-can easily wind up at odds with each other. A recent study that looked at the role of state privacy laws in EMR adoption suggests that the problem is very real, as state privacy laws seem to inhibit the use of EMR by hospitals located there. The authors, based at MIT and the University of Virginia, line up a variety of data that validate their suggestion that privacy and the use of EMR may require a careful balance. So, for example, they cite some highly publicized lapses when it comes to the maintenance of patient privacy: someone once offered the records of 200,000 patients for sale on Craigslist, while hospitals have seen their own employees attempt to get at the electronic files of famous patients. Perhaps more significantly, the authors suggest that the public, as represented by their legislators, has concerns about the privacy of EMR. They found that states that have passed their own privacy laws to supplement the HIPAA rules tend to have a higher percentage of their populace signed up for the Do Not Call Registry, indicating a corresponding individual-level interest in maintaining privacy. So, they looked at whether these laws had any impact on the adoption of EMR by hospitals located in each state.

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The Federal Trade Commission today approved a final consent order settling claims that CVS Caremark violated customers' privacy and the Health Information Portability and Accountability Act (HIPAA) when it failed to dispose of records properly last year. Earlier this year, CVS Caremark agreed to settle FTC charges that it failed to take reasonable and appropriate security measures to protect the sensitive financial and medical information of its customers and employees, in violation of federal law. In a separate but related agreement, the company's pharmacy chain also has agreed to pay $2.25 million to resolve Department of Health and Human Services allegations that it violated HIPAA regulations. "This is a case that will restore appropriate privacy protections to tens of millions of people across the country," said FTC chairman William Kovacic following the settlement. "It also sends a strong message to other organizations that possess consumers' protected personal information. They are required to secure consumers' private information." Under the final consent order, CVS Caremark is required to rebuild its security and confidentiality program, which will be audited every two years for the next 20 years. The HHS settlement requires the company to develop a new training program to instruct employees on how to handle patient data.

CSOs in healthcare organizations know that the Health Information Technology for Economic and Clinical Health (HITECH) Act, signed into law in February 2009, includes new privacy requirements that experts have called "the biggest change to the health care privacy and security environment since the original HIPAA privacy rule." These include: New requirements that widen the definition of what Personal Health Information (PHI) information must be protected and extend accountability from healthcare providers to their business associates; Lower thresholds, shorter timelines, and stronger methods for data breach victim notification; Effective immediately, increased and sometimes mandatory penalties with fines ranging from $25,000 to as much as $1.5 million; More aggressive enforcement including authority to pursue criminal cases against HIPAA-covered entities or their business associates. No doubt, the HITECH Act raises the stakes for a data breach. But regulations aside, data breaches can hurt your organization's credibility and can carry huge medical and financial risks to the people whose data is lost. We've managed hundreds of data breaches and helped thousands of identity theft victims. Through this we've learned firsthand that compliance doesn't necessarily equal low risk for data breach. For the well being of the business and patients, healthcare organizations and their partners need to take the most comprehensive approach to securing PHI.

Health IT industry leaders and privacy advocates are watching carefully to see how the federal government will enforce expanded health data breach notification rules set to take effect this week, Federal Computer Week reports. HHS' breach-notification rule, which applies to HIPAA-covered entities and business associates, is scheduled to take effect tomorrow. The Federal Trade Commission's companion rule, which applies to personal health record vendors and other non-HIPAA-covered entities, is scheduled to take effect Thursday. The federal economic stimulus package mandated the creation of both rules.

"If you live in Texas, your medical records are definitely up for sale by the state. If you live anywhere else in the United States, they probably are for sale there, too. Medical health records provide key information to researchers, who have lobbied hard to keep them accessible, despite government concerns about the privacy of patient data. The controversy dates back to 1996, when Congress passed the Health Insurance Portability and Accountability Act (HIPAA) to protect patients. "Researchers have very broad access rights to health care records under HIPAA," says Pam Dixon, director of a non-profit called the World Privacy Forum "The rules are pretty loose, and there are a lot of ways to get around them." That's especially true since the act wasn't designed to cover common scenarios today: records stored online in a vast, hackable cloud. In the rush to digitize all electronic health records, Dixon says not everyone is taking the proper steps to de-personalize the data and protect patients."

For the third time in recent months, Tampa Bay citizens have found themselves the unwanted recipients of patients' private medical records. What's more, in two cases, the recipients' efforts to restore patients' privacy were rebuffed, suggesting the federal Health Insurance Portability and Accountability Act (HIPAA) is falling far short of its promise to protect and enforce patient privacy.

If the government won't enforce HIPAA, why bother having the law at all. Let patients know they are own their own.

This year was an interesting year in privacy and information security, and by looking back, we can clearly discern trends that will likely be a major part of the security management landscape in 2009. More and more states passed breach-notification laws and several enhanced or extended existing legislation. Software-as-a-Service (SaaS) and virtualization really took off, and compliance's looming presence grew with PCI DSS version 1.2 and some actual enforcement of HIPAA. Of particular note was Massachusetts' data breach law 201 CMR 17.00: Standards for The Protection of Personal Information of Residents of the Commonwealth. This is to date the most comprehensive law of its kind, setting a new standard for what breach-notification laws should look like; it covers both paper and electronic records, it mandates appropriate security awareness training as well as security and risk assessments and, most importantly, requires companies to make changes to their security programs in accordance with the findings of those risk assessments. Similarly, California enhanced the well-known CA-1386 to include not just traditional financial information, but also health care and health insurance data as well. With new mandates popping up all the time, it's no wonder compliance was one of the biggest focus areas for enterprise information security teams in the past year, and this trend will clearly continue in 2009; there will be more regulation on both the state and federal levels, and stronger enforcement of existing regulations. Fines and other penalties for violations of PCI DSS and HIPAA will continue to rise, along with the inevitable rise in discoveries of malfeasance. As a result, there will be an even larger focus on compliance by upper management, which also means decreased time and budget for necessary security controls that don't clearly fall under a compliance umbrella.

When the director of IT at a Boston-based, midsize pharmaceutical firm was first approached to participate in a data leakage audit, he was thrilled. He figured the audit would uncover a few weak spots in the company's data leak defenses and he would then be able to leverage the audit results into funding for additional security resources. "Data leakage is an area that doesn't get a lot of focus until something bad happens. Your biggest hope is that when you raise concerns about data vulnerability, someone will see the value in allowing you to move forward to protect it," the IT director says. But he got way more than he bargained for. The 15-day audit identified 11,000 potential leaks, and revealed gaping holes in the IT team's security practices. (Read a related story on the most common violations encountered.) The audit, conducted by Networks Unlimited in Hudson, Mass., examined outbound e-mail, FTP and Web communications. The targets were leaks of general financial information, corporate plans and strategies, employee and other personal identifiable information, intellectual property and proprietary processes. Networks Unlimited placed one tap between the corporate LAN and the firewall and a second tap between the external e-mail gateway and the firewall. Networks Unlimited used WebSense software on two servers to monitor unencrypted traffic. Then it analyzed the traffic with respect to company policy. Specifically, Networks Unlimited looked for violations of the pharmaceutical firm's internal confidentiality policy, corporate information security policy, Massachusetts Privacy Laws (which go into effect in 2010), Health Insurance Portability and Accountability Act (HIPAA), and Security and Exchange Commission and Sarbanes-Oxley regulations. Auditor Jason Spinosa, senior engineer at Networks Unlimited, says that while he selected the criteria for this audit, he usually recommends that companies take time to determine their policy settings based on their risk

Hospital CIOs, chief information security officers, and privacy officers are working diligently to keep their names off that wall. But they are dealing with a regulatory environment that is still in flux. A final rule that will strengthen HIPAA privacy and security safeguards is due out before the end of the year. HHS also has proposed a rule for the accounting of disclosures from electronic records. The biggest shift under way may be a new enforcement regime as the HHS Office for Civil Rights (OCR) shifts gears from only reacting to data breach reports to begin random audits of the privacy and security safeguards of large and small providers and their business associates. Another new wrinkle under the HITECH Act is that state attorneys general can file civil lawsuits for HIPAA violations.

The recent U.S. stimulus bill includes $18 billion to catapult the health industry toward the world of electronic health records. This is sure to light a fire under every hungry security vendor to position itself as the essential product or service necessary to achieve HIPAA compliance. It should also motivate healthcare IT professionals to learn where their sensitive data is located and how it flows. To be sure, with federal money allocated through 2014 for the task of modernizing the healthcare industry there will be many consultant and vendor businesses that will thrive on stimulus money. Healthcare is unique in that storage of electronic health records is highly distributed between primary care physicians, specialist doctors, hospitals, and insurance/HMO organizations. Information has to be efficiently shared among these entities with great sensitivity towards patient privacy and legitimate claims processing. Patients want to prevent over zealous employers from performing unauthorized background checks on medical history; claim processors want to prevent paying fraudulent claims arising from targeted patient identity theft. The bill has two provisions which turn this into a tremendously challenging plan, and a daunting task for securing patient data: * Citizens will have the right to monitor and control use of their own health data. This implies a large centralized identity and access control service, or perhaps a federated network of patient registration directories. Authenticated users will be able to reach into the network of health databases audit use of their data and payment history. * Health organizations suffering loss of more than 500 patient records must publicly disclose the breach, starting with postings on the government's Health and Human Services website. This allows related organizations to trace the impact of the breach throughout the healthcare network, but care must be taken not to disclose vulnerabilities in the system to intruders

"Can personal medical data that has been stripped of its identifiers to protect privacy later be used to identify a specific person? That is the question that the Health and Human Services Department is hoping a research contractor can answer. HHS intends to hire a contractor to demonstrate either the "ability or inability" to re-identify data from a data set that has been de-identified under the Health Information Portability and Accountability Act (HIPAA) Privacy Rule, according to a Jan. 4 notice on the Federal Business Opportunities Web site. De-identification and re-identification of patient data have become hot issues in the discussion about how to protect patient privacy while advancing adoption of electronic health records. The Obama administration is distributing at least $17 billion in incentive payments to doctors and hospitals who buy and use digital systems for medical data."

First quarter federal reports show Google lobbied on the electronic medical records provisions of the federal economic stimulus act, contradicting the Internet giant's earlier claims that Consumer Watchdog's report of its effort was "100 percent false." Google's report shows a total expenditure of $880,000 on lobbying during the period including on "online health-related initiatives; issues relating to online personal health records, including in connection with H.R. 1: American Recovery and Reinvestment Act of 2009." Google also contracted with an outside firm, the Podesta Group, which independently reported lobbying for Google on "health information technology" and "online privacy." King and Spalding LLP also independently reported lobbying for Google on "online health-related initiatives, including health information technology provisions in H.R. 1, The American Recovery and Reinvestment Act." After the nonprofit, nonpartisan Consumer Watchdog reported the "rumored" lobbying in January, Google contacted a charitable foundation about withdrawing Consumer Watchdog's funding. In a letter to Google CEO Eric Schmidt released today, Consumer Watchdog said the company owes the group an apology. Read Consumer Watchdog's letter here: http://www.consumerwatchdog.org/resources/LtrSchmidt042209.pdf. "It is now clear from public records that Google was lobbying Congress relating to online personal health records in connection with the economic stimulus act... What else could Google have been seeking except to be excluded from the Health Insurance Portability and Accountability Act (HIPAA) provisions on privacy and forbidding sale of records? Please tell us," wrote Jamie Court, Consumer Watchdog president and John M. Simpson, consumer advocate. "There is a simple way to resolve this," the letter said. "Publicly release all the substance of Google's lobbying efforts on H.R. 1. Google knows the drill: organize the information and make it universally accessible and useful."