New York's Highest Court To Say Whether Medical Practice Can Be Sued For Wrongful Texts By Non-Physician Employee

In this case (Doe v Guthrie Clinic, Ltd, March 25, 2013), the Second Circuit Court of Appeals (covering New York, Connecticut and Vermont) is asking New York's highest court to determine whether the common law permits a medical corporation to be sued for a breach of the fiduciary duty of confidentiality concerning patient medical records when a non-physician employee makes an unauthorized disclosure of those records. The position the New York Court of Appeals takes will be watched closely by health care providers across the Empire State as the requirements for securing patient data continue to tighten with, among other things, the final HIPAA regulations being issued under HITECH this past January.

Here, Doe (patient) sued Guthrie Clinic because one of the clinic's nurses (and sister-in-law of Doe's girlfriend) texted Doe's girlfriend about Doe's treatment for a sexually transmitted disease (STD). All of the patient's claims, including a claim for common law breach of fiduciary duty to maintain the confidentiality of personal health information, were dismissed by the lower court. Doe appealed the dismissal to the Second Circuit. 

The federal appellate court reversed the dismissal of the fiduciary breach claim, noting that New York courts have not addressed this situation. That is, there are no decisions in New York that specifically address whether a medical practice could be liable under a breach of fiduciary duty theory when its non-physician employee wrongfully discloses confidential medical information. Employers in New York generally are liable for the foreseeable actions of their employees which are within the scope of employment, but usually not when those actions are driven by personal reasons of the employee.

Under the facts in this case, New York's high court may find no cause of action exists, leaving patients/plaintiffs with one less avenue to sue. The risks and exposures remain, however, for health care providers who will incur significant costs defending these actions in court and addressing complaints before state and federal agencies. Strong policies and employee training  will not prevent patient claims and complaints, but they will help to put providers in a better position to defend their actions.

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Final HIPAA Regulations: "Business Associates" Include Subcontractors, Data Storage Companies (Cloud Providers?)

Under the HITECH Act, business associates are subject to the HIPAA privacy and security rules (the "HIPAA Rules") virtually to the same extent as covered entities. In addition to implementing this change for business associates ("BAs"), and providing additional guidance concerning what entities are business associates, the final HIPAA regulations issued last week also treat certain subcontractors of BAs as BAs directly subject to the HIPAA Rules. As a result of some of these changes, covered entities and BAs need to re-examine the relationships with their subcontractors to ensure they obtain the appropriate satisfactory assurances concerning the "protected health information" (PHI) they make available to those subcontractors.

Below are some of the key points from the final regulations concerning BAs and subcontractors:

  • Subcontractors. The final HIPAA regulations provide that subcontractors that create, receive, maintain, or transmit PHI on behalf of a BA are business associates. This is a significant expansion of the application of the HIPAA Rules; it makes subcontractors directly liable under the HIPAA Rules.

As a result of this change, just as covered entities need to ensure that they obtain satisfactory assurances concerning compliance with the HIPAA Rules (usually in the form of a business associate agreement, BAA) from their BAs, BAs must do the same with regard to certain subcontractors. This must continue no matter how far “down the chain” the PHI flows.

  • Business Associate Agreement Not Necessary to Establish Status as Business Associate. The final HIPAA regulations confirm that persons and entities that meet the definition of a BA have that status regardless of whether a "business associate agreement" is in place.
  • Data Storage Companies. Entities that maintain PHI (digital or hard copy) on behalf of a covered entity are BAs, "even if [they] do not actually view the [PHI]."  This provision may create significant compliance issues for cloud service providers, as well as hard copy document storage companies, that have access to the records of their clients but may never look at them. 
  • Certain Groups Not Considered Business Associates.
    • Researchers generally are not considered BAs when performing research functions.
    • Banking institutions generally are not considered BAs with respect to certain payment processing activities (e.g., cashing a check or conducting a funds transfer)
    • Malpractice insurers generally are not considered BAs when providing services related to the insurance, but may be BAs when providing risk management and similar services to covered entities.

Transition rule for compliance. A transition rule under the final HIPAA regulations permits covered entities and BAs to continue to operate under certain existing contracts for up to one year beyond the compliance date (September 23, 2013) of the final regulations. A qualifying business associate agreement will be deemed compliant until the earlier of (i) the date such agreement is renewed or modified on or after September 23, 2013, or (ii) September 22, 2014. This rule only applies to the language in the agreements, the parties must operate as required under the HIPAA Rules in accordance with the applicable compliance dates. 

Covered entities and business associates may want to act more quickly to identify and contract with those individuals and entities from whom they must obtain satisfactory assurances under HIPAA.

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Final HIPAA/HITECH Privacy and Security Regulations Released

The Office for Civil Rights released on January 17, 2013, final privacy and security regulations (563 pages) under the Health Insurance Portability and Accountability Act. The rules address four key issues:

  • Reflecting the changes made by the Health Information for Economic and Clinical Health Act (HITECH);
  • Revisions to the HIPAA enforcement rule;
  • Updates to the previously issued data breach regulations; and
  • Incorporating the changes made by the Genetic Information Nondiscrimination Act.

In general, covered entities and business associates will need to comply by September 23, 2013. We expect to be reporting on some of the key changes shortly.  

ACCESS SUMMARY HERE
 

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Are Cloud Service Providers Business Associates under HIPAA and the HITECH Act?

As more companies move to the cloud, regulatory compliance remains a critical issue. For cloud service providers to the healthcare industry, it looks like the requirement to comply with the HIPAA privacy and security rules as business associates will be confirmed when long-awaited final regulations are issued, based on a report by Marianne Kolbasuk McGee with Healthcare Information Security. According to Ms. McGee's report, Joy Pritts, chief privacy officer in the Office of the National Coordinator for Health IT, a unit of the Department of Health and Human Services, addressed this issue during a Jan. 7 panel discussion on cloud computing hosted by Patient Privacy Rights.

Cloud service providers would prefer to take the position that they are conduits to protected health information, and therefore not business associates, similar to the US Postal Service, and certain private couriers and their electronic equivalents. See HIPAA FAQ.  A conduit transports information but does not access it other than on a random or infrequent basis as necessary for the performance of the transportation service or as required by law. However, HHS has already noted that "a software company that hosts the software containing patient information on its own server or accesses patient information when troubleshooting the software function, is a business associate of a covered entity." See HIPAA FAQ

According to Ms. Pritts' remarks in the report cited above, it appears that the modifications made to HIPAA under the Health Information Technology for Economic and Clinical Health (the HITECH Act), along with anticipated regulatory guidance, will remove any doubt that cloud service providers servicing HIPAA covered entities are "business associates." This would require, among other things, that covered entities enter into business associate agreements with their cloud providers, and that standard confidentiality clauses likely will be insufficient. Of course, covered entities, practitioners and others are looking forward to these long awaited regulations to help clarify this and other issues.

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Small HIPAA Breach (Affecting Fewer Than 500) Leads to Substantial Penalties

The U.S. Department of Health and Human Services’ (HHS) reported today its first settlement involving a breach of unprotected electronic protected health information (ePHI) affecting fewer than 500 individuals. According to a statement from the Office for Civil Rights Director Leon Rodriguez, “This action sends a strong message to the health care industry that, regardless of size, covered entities must take action and will be held accountable for safeguarding their patients’ health information.”

The breach occurred in June 2010, when an unencrypted laptop belonging to the Hospice of North Idaho (HONI) that contained ePHI of 441 patients was stolen. The Office for Civil Rights (OCR) learned of the incident when HONI reported it to OCR pursuant to the annual reporting requirement for breaches affecting fewer than 500 individuals under the Health Information Technology for Economic and Clinical Health (HITECH). When OCR investigated, it discovered "that HONI had not conducted a risk analysis to safeguard ePHI." OCR also reported that HONI did not have in place policies or procedures to address mobile device security as required by the HIPAA Security Rule. 

HONI agreed to pay HHS $50,000 to settle potential violations of the Security Rule.

 

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Alaska DHSS HIPAA Breach Affects 501 Individuals, But Results in $1.7 Million Settlement with HHS Following Compliance Review

When an electronic storage device potentially containing ePHI was stolen from the vehicle of an Alaska Department of Health and Social Services (DHSS) employee on October 12, 2009, DHSS reported the breach to the Office of Civil Rights (OCR) pursuant to the HIPAA breach notification rule. The breach reportedly affected 501 individuals. However, according to a resolution agreement, OCR's subsequent investigation found significant violations of some of the most basic HIPAA rules. Without admitting liability, DHSS agreed to pay $1,700,000 and to comply with a three-year corrective action plan.

After four rounds of written responses from DHSS, and a two-day on-site visit, OCR found that  DHSS had not:

  1. completed a risk analysis;
  2. implemented sufficient risk management measures;
  3. completed security training for DHSS workforce members;
  4. implemented device and media controls; or
  5. addressed device and media encryption.

Data breaches continue to occur on a fairly regular basis, and the ubiquity of electronic storage devices, particularly those that are not encrypted, make these incidents even more likely. This and other cases should help covered entities to realize that enforcement agencies are acting on notices they receive under the applicable breach notification statutes or regulations to find compliance violations.

This kind of enforcement activity, as with this case, could turn out to be quite a lucrative practice for cash strapped federal and state agencies. It is no wonder that some states are amending their statutes to require Attorney General notification. Accordingly, because data breaches can and will occur, HIPAA covered entities and businesses subject to HIPAA and state data breach notification statutes should be doing more to be prepared for the audit that may follow the reporting of a data breach. That is, they should be doing more to safeguard personal information and PHI pursuant to the applicable standards.  

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OCR Issues Protocol For HIPAA Privacy, Security and Breach Notification Audit Program

As we previously discussed, the Office of Civil Rights (“OCR”) continues to push forward with the HIPAA audits required by the HITECH Act.  To this end, the OCR recently posted the protocol which is used to conduct the HIPAA audits on its website. 

The HITECH Act requires HHS to provide for periodic audits to ensure covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards.  To implement this mandate, OCR piloted a program to perform audits of covered entities to assess privacy and security compliance.   This HIPAA audit program analyzes processes, controls, and policies of selected covered entities (e.g., health plans, health care clearinghouses, and certain health care providers) as well as the requirements to be assessed through these performance audits. The audit protocol is organized around “modules,” as follows:

  • The first audit protocol covers Privacy Rule requirements for (1) notice of privacy practices for Protected Health Information (“PHI”), (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures.
  • The second protocol covers Security Rule requirements for administrative, physical, and technical safeguards.
  • The third protocol covers requirements for the Breach Notification Rule.

Notably, the combination of these multiple requirements may vary based on the type of covered entity selected for review.  Healthcare providers, health plans, and business associates, all who could be affected by the HIPAA audits, need to not only be aware of the OCR’s audit activities, but also HHS’s efforts to increase enforcement of HIPAA.   

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HHS Makes HIPAA Training Materials Available to State Attorneys General

To date, State Attorneys General (State AGs) in at least four states (Connecticut, Indiana, Minnesota, Vermont) have exercised their authority to enforce the HIPAA privacy and security rules as granted by the Health Information Technology for Clinical and Economic Health (HITECH) Act (pdf), part of the American Recovery and Reinvestment Act of 2009 (ARRA). Following a nationwide live training campaign, the Office of Civil Rights (OCR) is continuing its efforts to train State AGs by making training materials available online

The training materials now available through the OCR website include videos and slides from in-person training sessions for State AGs that OCR conducted in 2011, as well as computer-based training modules that can be downloaded. Topics include:

  • General introduction to the HIPAA Privacy and Security Rules
  • Investigative techniques for identifying and prosecuting potential violations
  • A review of HIPAA and State Law
  • OCR's role in enforcing the HIPAA Privacy and Security Rules
  • State AG roles and responsibilities under HIPAA and the HITECH Act
  • Resources for State AGs in pursuing alleged HIPAA violations
  • HIPAA Enforcement Support and Results

State AG interest in pursing these cases may be growing. For example, the Connecticut Attorney General's website instructs residents on how to file complaints concerning HIPAA. This action by OCR also may indicate it is closer to issuing the long awaited final regulations under HITECH. Health care providers, health plan sponsors and administrators and business associates should be taking steps to ensure they are ready to survive a HIPAA audit, as well as an enforcement action by a State AG. 

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Third Party Vendors Equal Data Breach Risk, Massachusetts Vendor Contract Deadline Approaches - March 1, 2012

According to a Ponemon Institute study*, data breaches occurring in the hands of third-party vendors amounted to 39 percent of breaches in 2010.  Whether it be cloud service providers, benefits brokers, medical billing services, debt collection companies, consultants, accountants, law firms, staffing services, shredding/data destruction services, cleaning service providers and other businesses, most companies utilize third party vendors to provide an array of services. Those services often involve letting the vendor access, store and/or process personal information, which creates additional risk and legal obligations for the company using the vendor, such as the service provider contract requirement in Massachusetts.

Massachusetts deadline. A number of states have passed laws requiring companies that put personal information in the hands of third party service providers must obtain the written agreement of the third party to safeguard this information. The Massachusetts data security regulations that went into effect March 1, 2010, gave businesses until March 1, 2012 to update contracts with service providers that were entered into no later than March 1, 2010. However, next month that grace period expires. Thus, beginning March 1, 2012, a contract to safeguard personal information must be in place with all service providers who handle personal information concerning a Massachusetts resident on behalf of the company.   

Other mandates. Requirements to ensure third party vendors are safeguarding personal information is not limited to Massachusetts. Examples include:

  • States such as California, Maryland, Nevada, Oregon, and Texas have had for some time a contract requirement similar to the Massachusetts rule.
  • The privacy and security regulations under HIPAA have a more expansive requirement for “business associates” and “subcontractors.” Businesses subject to HIPAA are anxiously awaiting final regulations under HITECH which will be specifically addressing business associate agreement requirements, among other things.
  • The Payment Card Industry (PCI) standards require similar agreements.
  • Law firms in many states are subject to specific state ethical mandates to have written assurances from vendors handling client data (these mandates are not limited to personal information, but seem to apply to all client information). For example, lawyers in states such as ME, MO, NJ, NY, OR, VT, WI are required to make sure that contractors maintain appropriate safeguards through a “legally enforceable obligation.”   

What to do next? Vendor management should be part of an overall strategy to safeguard company and personal information. It is important to add that while personal information typically is the focus of this risk because of the breach reporting obligations across the country, confidential and proprietary company data is, of course, also at risk in the hands of vendors.

Companies should develop a list of all of their vendors and require all that have access to sensitive personal or company information to agree to amend the services agreement to include a requirement that the vendor have in place appropriate data privacy and security safeguards. Careful negotiations and drafting is critical to ensure legal compliance and protection/indemnity in the event of a data breach. In addition, some business might want to maintain a right to audit operations and require certain specific safeguards, depending on the volume and sensitivity of the information at issue. Companies also have developed comprehensive questionnaires and assessments for their vendors to complete to obtain a more complete picture of the vendors' data security protocols.

Whatever the approach, companies should at a minimum obtain written assurances from their vendors concerning the safeguarding of personal information.  
 

 

*Ponemon Institute, LLC. 2010 Annual Study: U.S. Cost of a Data Breach, March 2011.

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Provide Feedback to Government on Exchanging Health Information on Mobile Communications Devices

If you have an interest in the role the growing use of mobile communications devices (smart phones, iPads, iPhones, etc.) will play in how personal health information is exchanged in the health care industry, the Office of the National Coordinator for Health Information Technology (ONC) is seeking your input. According to a notice published Nov. 1, 2011 (76 Fed. Reg. 67455), comments are due Dec. 31.

As part of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009, ONC is proposing to conduct a nationwide communication campaign to meet the Congressional mandate to educate the public about privacy and security of electronically exchanged personal health information. To conduct the campaign effectively, ONC requires "formative and process information" about different segments of the public. Among other things, ONC is seeking comments on consumer attitudes and preferences about the use of these devices to exchange health information, including how privacy and security information is presented electronically to consumers.

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HHS to Help Train State Attorneys General to Enforce HIPAA

HHS continues to show signs of increased enforcement of HIPAA. Earlier this month, the agency announced it would hold 2-day, instructor-led HIPAA Enforcement Training courses in 4 locations across the country. Some Attorneys General, such as Connecticut's former Attorney General Richard Blumenthal, have already used their new found authority to enforce HIPAA. This announcement follows two significant, high profile Office of Civil Rights (OCR) press releases touting its own enforcement activities, one involving the first imposition of penalties under HIPAA and the other involving a significant settlement with a Massachusetts hospital

The Health Information Technology for Clinical and Economic Health (HITECH) Act (pdf), part of the American Recovery and Reinvestment Act of 2009, gave State Attorneys General the authority to bring civil actions on behalf of state residents for violations of the HIPAA Privacy and Security Rules. The HITECH Act permits State Attorneys General to obtain damages on behalf of state residents or to enjoin further violations of the HIPAA Privacy and Security Rules.

Attendees at each of the HIPAA Enforcement Training sessions will receive instruction on a number of enforcement topics including:

  • Investigative techniques for identifying and prosecuting potential violations
  • A review of HIPAA and State Law
  • The role and responsibility of an Attorney General under HIPAA and the HITECH Act
  • Resources available to Attorneys General to pursue alleged HIPAA violations

In addition to training, OCR promises that it will collaborate with and assist State Attorneys General seeking to bring civil actions to enforce HIPAA and Security Rules. This collaboration and assistance will include OCR providing to Attorneys General (i) information upon request about pending or concluded OCR actions against covered entities or business associates related to attorney general investigations, and (ii) guidance regarding the HIPAA statute, the HITECH Act, and the HIPAA Privacy, Security, and Enforcement Rules as well as the Breach Notification Rule.  

While years of lax enforcement may have lulled many HIPAA covered entities and business associates to not take HIPAA seriously, these recent activities should spur renewed efforts toward compliance. 

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California Department of Public Health Continues to Fine Hospitals and Nursing Homes for Data Breaches

Coauthored with Jason Gavejian

California hospitals and nursing homes take note - the California Department of Public Health (CDPH) takes data breaches seriously. Since June of this year, CDPH has imposed nearly $1.5 million in fines affecting 12 California health facilities. California Health and Safety Code 1280.15(a) requires covered health facilities to prevent unlawful or unauthorized access, use or disclosure of patient medical information.

Violations of this requirement can result in penalties of up to $25,000 per patient and up to $17,500 per subsequent occurrences of unlawful or unauthorized access, use or disclosure of that patients medical information

In its most recent wave of penalties, announced November 19, 2010, CDPH assessed fines totaling $792,500 against six hospitals and one nursing home that it determined failed to prevent unauthorized access to confidential patient medical information. In one case, a health facility was fined $310,000:

  • $60,000 because the facility failed to prevent unauthorized access and disclosure of one patient’s medical information by two employees on three occasions.
  • $250,000 because the facility failed to prevent the theft of 596 patients’ medical information

The larger penalty resulted in part when laboratory reports of 596 patients were lost. In its investigation, CDPH learned that the staff employee at the facility responsible for running and storing laboratory reports, and who had signed the facility's confidentiality statement, placed lab reports in an outside locker, but did not lock the locker because the lock was not working and the locker door was broken. This staff member told CDPH the locker had been broken for several months, although he did not report it. The lab reports that were lost included patient names, Social Security numbers and laboratory results, among other personal information. 

Beyond that, California health facilities should be reminded of Cal. Health and Safety Code § 1280.15, which requires covered facilities to notify CDPH and affected individuals of “unlawful or unauthorized access to” personal health data within five business days after discovery of a breach. Late notices can result in fines of $100 per day for each patient affected, up to maximum of $250,000. Of course, health care providers also need to take into account the interim final rules, promulgated under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act and enforced by the Department of Health and Human Services (“HHS”), which require entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”) to report similar incidents.  Under the HIPAA rules, notice must be provided without "unreasonable delay."

As the number of data security incidents in the health care industry continue to mount, CDPH's enforcement activity should urge covered health facilities in California to pay greater attention to data security. As the incident above makes clear, simply requiring an employee to sign an acknowledgment of complying with facility data security policy will not be enough. Health facilities, including hospitals and nursing homes, need to continually assess their risks in this area and create a culture of data privacy and security across their organizations. This can only be accomplished through clear policy and frequent training and attention to the issue. 

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Attorney General Securing Personal Data in Indiana

Indiana recently enacted a new law which grants authority to the Indiana Office of the Attorney General's Identity Theft Unit to obtain and secure abandoned records with personally identifying information, including health records, and either destroy them or return them to their owners. Additionally, the new law sets fines and other legal ramifications for violations of the law by health care providers or licensed professionals who leave such records unsecured in violation of state law. In fact, the Attorney General has already utilized this authority to obtain personal records from four entities. 

This additional grant of authority to the Indiana Attorney General, is in addition to the authority previously granted by the Health Information Technology for Economic and Clinical Health (HITECH) Act to enforce the privacy and security protections of HIPAA for protected health information. As we have previously discussed, the Connecticut Attorney General has filed a civil action against Health Net, as well as instituted an investigation against Griffin Hospital for violations of HIPAA. 

The Indiana statute, as with the authority granted to Attorney Generals under HITECH, highlight the need for companies to develop and implement comprehensive data security polices to secure their records. 

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HHS to Issue Proposed Regulations Concerning HITECH

The Department of Health and Human Services announced this morning that it will be issuing a notice of proposed rulemaking to begin implementing the recent statutory amendments under the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act”). According to HHS, the proposed regulations (pdf), set to be published July 14, 2010, are designed to strengthen the privacy and security protection of health information, and to improve the workability and effectiveness of the existing HIPAA privacy and security rules. 

More specifically, the proposed rules would modify the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule), the Security Standards for the Protection of Electronic Protected Health Information (Security Rule), and the rules pertaining to Compliance and Investigations, Imposition of Civil Money Penalties, and Procedures for Hearings (Enforcement Rule) issued under HIPAA.

We will be reviewing these regulations and reporting on them further as appropriate.

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New Challenges for HIPAA Business Associates Under ARRA and HITECH

Have you noticed that negotiating that business associate agreement has gotten a lot more difficult? Many companies that serve health care providers and health plans, generally known as business associates, have noticed. These companies include software vendors, benefits brokers, cloud computing providers, data storage/destruction companies, and accountants, among others.

The clients of these companies are citing HIPAA, ARRA, HITECH, data breach notification requirements, and state law mandates as they demand stricter contract language and additional rights and protections, such as the right to audit the business associate and to be held harmless in the event of any data mishap. Business associates that took HIPAA lightly in 2003 and 2004, when the HIPAA regulations first became effective (2005 and 2006 for the security regulations), are playing catch-up.

When President Obama signed the American Recovery and Reinvestment Act of 2009 (ARRA), “business associates” may not have expected the significant effects that law would have on their businesses. Chief among those effects are mainly due to four sentences in The Health Information Technology for Economic and Clinical Health (HITECH) Act (pdf), passed as part of ARRA, and which generally became effective on February 17, 2010 (the breach notification mandate became effective on September 23, 2009), one year after enactment:

  • “Sections 164.308, 164.310, 164.312, and 164.316 of title 45, Code of Federal Regulations, shall apply to a business associate of a covered entity in the same manner that such sections apply to the covered entity. The additional requirements of this title that relate to security and that are made applicable with respect to covered entities shall also be applicable to such a business associate and shall be incorporate[d] into the business associate agreement between the business associate and the covered entity.” ARRA Sec. 13401(a). This statement makes business associates directly subject to nearly all of the HIPAA security regulations, the HIPAA rules relating to electronic protected health information. Prior to the change, these obligations existed for business associates only as a matter of contract.
  • “A business associate of a covered entity that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information shall, following the discovery of a breach of such information, notify the covered entity of such breach.” ARRA Sec. 13402(b). This statement creates a new obligation for business associates – report to covered entities breaches of unsecured protected health information.
  • “The additional requirements of this subtitle that relate to privacy and that are made applicable with respect to covered entities shall also be applicable to such a business associate and shall be incorporated into the business associate agreement between the business associate and the covered entity.” ARRA Sec. 13404(a). This statement makes business associates directly subject to nearly all of the HIPAA privacy regulations. Prior to the change, as with the security regulations, these obligations existed for business associates only as a matter of contract.

In response to these law changes, and in the absence of regulatory guidance, covered entities have been demanding modifications to existing business associate agreements or requesting new agreements. In both cases, covered entities are seeking greater assurances from their business associates concerning the handling of the covered entities’ protected health information.

On top of that, covered entities are weaving into business associate agreements and other agreements requirements under newly enacted state laws requiring protections for “personal information” in the hands of vendors (e.g., business associates) to curb identity theft. Given the cost and reputational harm that could come from a data breach, as well a growing enforcement activity, many covered entities are becoming more forceful in their negotiations, citing legal mandates and established company policies for their unwillingness to budge on many provisions, even those that go beyond statutory mandates.

What is a business associate to do? Here are some thoughts:

  1. Confirm your company is a business associate. (go to HHS HIPAA frequently asked questions and insert "business associate" for helpful guidance). In some cases, covered entities are blanketing all of their vendors with these agreements. If believe your company is not a business associate, raise it with your client. Of course, even if you avoid being considered a business associate, your customer/client still may demand written assurances under state law for the personal information you handle on its behalf.
  2. Become compliant. As noted above, the HIPAA privacy and security requirements are now directly applicable to business associates. While additional guidance is expected as to what this means precisely, there is enough existing guidance concerning covered entities for business associates to use to achieve compliance. Among other things, compliance means conducting a risk assessment, adopting a written set of policies and procedures concerning the safeguarding of protected health information, and training staff. Being compliant not only reduces risk, but in an environment of increasing attention to data privacy and security, compliance can be a competitive advantage.
  3. Review agreements carefully. Covered entities increasingly include contract provisions that provide the covered entity with greater protections than the law requires. To the extent possible, try to remove those provisions. In any event, it is important to know your obligations under these agreements; they can vary dramatically from covered entity to covered entity.
  4. Develop strategies for reviewing/complying with multiple contracts. Some business associates have many clients and, therefore, business associate agreements. Managing unique provisions multiple agreements can be daunting, although the ability to negotiate a uniform agreement across a client basis is increasingly unlikely. So, where possible, try to use similar provisions in all agreements and know ahead of time your approach to certain key provisions, such as handling data breaches.
  5. Understand the law. Even if you’ve mastered the determination of whether you are a business associate, the rules outlining your business' obligations likely will be evolving under HIPAA over the next few years, particularly with the expected growth of electronic health records and the expansion of health care. The same is true of state laws concerning personal information. In many cases these laws might coexist peacefully, in other cases there will be conflict. You need to be aware of the conflicts and be prepared to act accordingly.

 

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Best Buy Counsel Speaks on Data Privacy

On January 29, 2009, I had the opportunity to attend a brief presentation sponsored by Minnesota CLE entitled, “Corporate Data Privacy & Security: 10 Legal Practice Tips,” given by Brad Bolin, Senior Corporate Counsel for Best Buy, Inc. a Fortune 500 electronics retailer headquartered in Richfield, Minnesota. Bolin is a specialist in information security and privacy law. I was curious to hear what data privacy issues were on the mind of someone who monitors these issues for a living on behalf of a large corporation, especially a company that sells some of the very devices that make data privacy more challenging and which is known for its “results oriented” work environment. Many of the issues relate to topics discussed on this blog. The views expressed were strictly those of Bolin, not Best Buy. Here were his observations:

1. Work/Life Balance.  Electronic connections are collapsing the distinctions between work and personal life. Employees expect to be connected 24 -7. Bolin quoted Best Buy CEO Brian Dunn as noting, “Technology is … a constant backdrop in people’s lives, at home, at work, on the road and literally in the palms of their hands. We call it the ‘connected world’ and, as exciting as it is, it’s also increasingly complex, and difficult to keep pace with.”

12259312. Smart Phones Part 1.  Smart phones are becoming common and are a great example of how the “limited personal use” exception is swallowing the rule. He cited a survey showing that 20% of companies allow their employees to use personal devices for work, and the number is surely growing. Bolin discussed how under the old corporate model, a company that pays for an employee’s smart phone ought to take it back from the employee upon his or her departure, erase the contents and either recycle or reuse the device to prevent the disclosure of confidential corporate information. But what about the employee’s personal photographs, “apps”, movies, contacts and downloaded songs? What if the employee paid for the device but the company reimburses the cost? Securing employee-owned smart phones is not the same as securing corporate-owned devices, he emphasized.

3. Smart Phones Part 2.  Bolin said that, whatever rules you choose, a departing employee should be able to take his or her personal data, while IT should be able to ensure that any corporate information has been safely removed. The process should be simple and transparent to all. Adopt simple rules that make corporate data on an employee's smart phone easier to identify and control. For example, distinguish between media files on the one hand, and xls doc, ppt, and pdf documents on the other. Have a transparent dialog with employees about the trade-offs that exist cost when placing personal phones on the corporate network. For example, an employee might be required to archive SMS text messages on his phone for e-discovery purposes.

4. Texting Issues.  While e-mail typically is stored on a common server, text messages usually are stored by cell phone companies or directly on phones, and often the employer does not directly pay for their storage. Employers must have either a warrant or the employee's permission to see cell phone text messages that are not stored by the employer or by someone the employer pays for storage, Bolin said, citing Quon v. Arch Wireless, et al. 529 F.3d 892 (9th Cir. 2008),  The case is now under review by the United States Supreme Court.

5. TMI = Too much information.  An embedded Global Positioning System (GPS) feature is great for supporting and measuring effectiveness of a mobile sales force, but it raises the danger of collecting information about employees regarding the personal part of their life.

6. Social Networking.  Much has been made of social networking, he says, but this is not different in kind from past employee disclosure concerns, only in degree. Most policies on employee's social networking tend to be recitations of or references to standard confidentiality, acceptable use, and other policies. He suggests guidelines like:

a. Disclose your affiliation with your employer.

b. State that it’s your opinion, not the employer’s.

c. Protect yourself – be careful of disclosing personal information on line.

d. Act responsibly end ethically.

e. Respect diversity and honor policies against discrimination.

7. Monitoring Electronic Communications. Bolin says the “old news” is having an electronic communications policy addressing employee expectations of privacy when using company email. The “new news” is that companies have to have a governance policy in place regarding how the company may and will use such information, and it needs to follow it. Tools to gather emails and other electronic information today are immensely powerful, and very easy to use. The temptation will be great to pursue investigations without adequate cause, or without sufficient protective boundaries in place. Bolin cited the Hewlett Packard pretexting scandal of 2006.

8. HITECH Act (HIPAA Redux).  HIPAA is still HIPAA, Bolin says, but HITECH ups the ante by requiring breach notification to government and affected consumers of Protected Health Information (‘PHI”), and placing enforcement powers in the hands of the states attorneys general. Covered entities must promptly notify affected individuals, Health and Human Services (“HHS”) and the media in cases where a breach affects more than 500 individuals, and report ALL breaches on an annual basis. Bolin noted that the “hysteria” that has arisen around recent credit card breach notifications could well develop around PHI breach notifications.

11555789. Employee Privacy in Europe.  Privacy is fundamental human right in the European Union and, unlike in United States, can't be waived, Bolin emphasized. If a company wishes to transmit data concerning EU employees to the U.S., he noted, “you'll be required to bring your game up” and enact policies to take advantage of the safe harbor provision.

I think he gives us all some good points to consider.
 

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HIPAA Data Breaches in India Threaten Outsourcing Industry, Require Greater Vigilance at Home

A British TV station investigation into India's medical transcription industry, known as Business Process Outsourcing (BPO), uncovered unsettling news for British subjects, as well as American citizens. Medical records sent to India to be transcribed and computerized are being sold. The Economic Times report on the investigation out of New Delhi suspects a "hardening of stance on the outsourcing industry by the western world." The article states:

The revelation has forced police of the two countries to join hands to launch an official investigation into the data pilferage of the records stored by the Indian BPOs. If found true, the allegations could hit the flourishing BPO sector in India hard, fueling doubts about their integrity and efficiency.

Security breaches of this kind can have far reaching effects beyond the businesses and individuals directly impacted. The hopes for funding U.S. healthcare reform rest, in part, on administrative cost savings. Under the HITECH Act, enacted as part of the 2009 federal stimulus bill, the U.S. will spend 36 billion to spur the health care industry to purchase and create systems and equipment, including electronic health records systems, to better network the healthcare industry. Reluctance to outsource and increased security are likely to chip away at whatever cost savings can be achieved through enhanced technology in healthcare. 

In the short run, businesses must be more vigilant in vetting their vendors, as well as the vendors of their vendors. These efforts should include stronger agreements, deeper examinations of security protocols, knowing where information is ultimately stored and processed, and having a better understanding of the applicable legal and industry standards concerning data security. These efforts can not stop at the water's edge.

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