Source: http://garnerhealth.com/health-cares-adventures-in-wonderland/
Timestamp: 2019-04-23 10:52:25+00:00

Document:
As technology continues to evolve, there remains a general landscape with which those in the health care field must familiarize themselves. Even from this challenging vantage point, providers still have opportunities to bolster their position and practice their craft as they continue down the digital path and adopt an EHR system for which the Federal Government established incentive payments.
II. WHAT COULD GO WRONG?
In 2004 President George W. Bush announced his administration’s objective for “development and nationwide implementation of an interoperable health information technology infrastructure to improve the quality and efficiency of health care.” In fact, President Bush predicted that by 2014 there would be “an interoperable electronic health record for each U.S. resident.” Needless to say, President Bush’s goal is still a work in progress. Still, a decade later, 2015 has been a busy year for federal regulations on EHR incentive programs and meaningful use for EPs, all of which occurred concurrently with the downward payment adjustments under the Medicare EHR Incentive Program, updates to the certification criteria, as well as the Health IT Certification Program by the Office of the National Coordinator (“ONC”), and the solidification of the fate of the Merit-Based Incentive Payment System (“MIPS”) for EPs long into the future.
Today, the Federal Government has outlined four specific goals in its attempt to apply the “effective use of information and technology to help the nation achieve high-quality care at lower costs, a healthy population, and engaged individuals.” These goals include: (1) the advancement of person-centered and self-managed health; (2) the transformation of health care delivery and community health; (3) the fostering of research, scientific knowledge and innovation; and (4) the enhancement of the nation’s health IT infrastructure. A laudable objective notwithstanding, EHR implementation nevertheless has met with certain challenges along the way.
These so-called challenges present for certain Providers as larger obstacles to implementation. On the front line of health care reform, physicians must lead the EHR charge, even as they face the greatest risk individually without many opportunities to align independently. Even though many consider EHR to be cost prohibitive, the Federal Government addressed implementation, in part, when it encouraged physician and hospital alignment to further EHR. The track on which EHR exists appears to be incapable of derailment, but Providers would be remiss to think that the contractual agreements that create a vehicle with which they can join the convoy, contain the entire gamut of necessary rails. Rather, each Provider should examine the path ahead, paying careful attention to key terms that may prove the difference between digital success and demise.
When transitioning from paper to digital in any medical practice, Providers must familiarize themselves with basic field-related terminology, as well as gain a general understanding of the pending technological acquisition, not to mention what the potential developer/partner provides and what it demands in return. To be sure, such information is far more useful before signing an agreement than after execution. Not understanding some of the more salient terms and conditions of an agreement to acquire an her system, especially terms unique to this new digital frontier, can compromise a Provider’s medical practice, and have the potential to create vulnerabilities in the delivery of patient care as set forth below, if unfavorable terms were to evolve into medical risks. This section provides a general overview of key terms, the knowledge of which all Providers should be mindful.
In many contractual relationships, the notion of indemnification serves as the cornerstone for protection. In an EHR contract, the party charged with technology development (the “Developer”) must offer the EHR software to the health care provider (the “Provider”) with certain necessary services, and the Provider agrees to pay the cost (alone or with one or more third parties). Bound and isolated by the agreement, success is typically, dependent upon the actions and omissions of the Developer and Provider. Indemnification language in Developer contracts is critical, especially when third party claims loom in the distance. The degree to which one party must indemnify the other for transgressions, set forth in contractual indemnity provisions, can be the difference between success and failure. Other times, however, an agreement may be altogether silent on indemnification.
When drafting an indemnity clause, the Developer may insist the provider bear liability for any third party claims that arise from the EHR technology software. Providers should be reluctant to accept such liability, especially for technology outside the scope of the Provider’s expertise and control. Reasonable parties generally accept responsibility for the risk of reasonable culpability, but not much more. Developers will insist the Providers indemnify for all personal injury or death claims, at least to the extent such a claim includes third parties like Developers. Unless the harm to patient care resulted from an unlikely issue on the part of the Developers, such potential liability is not unreasonable for Providers to keep. Other claims, such as privacy violations, may not be as objective for purposes of allocating culpability. While this is a fundamental tenet of the system, there is often a fine line between a technical malfunction and “user error.” If possible, it is best to approach indemnification through mutuality, so that each party is responsible for its own acts and omissions.
When Providers and Developers contract, it would be nice to assume that all necessary software licenses and legal rights are in order, to accommodate the transaction. There are instances when a Developer intentionally, unintentionally or recklessly fails to obtain certain legal rights and, as a result, the third party who holds exclusive or superior ownership rights to the intellectual property, takes issue. Under California law, the owner of a patent or copyright for intellectual property has the right to sue anyone who uses the intellectual property without having first obtained the necessary rights. Indemnity can be as broad as a contract provides or even implied through its absence in an agreement, or in equity. Insurance, too, is prudent in an agreement, and those between Provider and Developer are no exception.
Too broad of a definition, however, could prevent a Provider from entering into meaningful negotiations, especially if a confidentiality agreement creates restrictions on disclosure to trusted advisors. Restrictions that prevent sharing certain information with other Providers could compromise certain networks if the sharing of such information proves important yet prohibited. In the field of health care, confidentiality is almost always important, but even privacy has certain limitations. Providers should be mindful not to become unnecessarily bound, especially when it comes to conducting business. At the same time, Providers should insist on protecting sensitive practice information, thereby making it critical that the confidentiality agreement is mutual. If this creates a source of contention with the Developer, it may signal yet again the importance of finding a different developer.
There are also exceptions to confidentiality obligations, despite the language in an agreement. One such instance includes disclosure mandated by law. Certain situations, however, may not create a legal obligation to disclose, but there may exist other reasons for why a party desires to volunteer information at the center of a confidentiality agreement, so appropriate language in a confidentiality agreement can still preserve the integrity of a Provider’s practice, as well as his or her reputation. Only by understanding the terms for a confidentiality agreement, can a Provider make certain, sensitive disclosures with confidence.
The path toward EHR has not always been without skeptics. While modern medicine may accept the importance of creating a digital record of each and every patient experience, the resulting disruption is not overlooked. “One of the under-told stories from the digitizing of patient records is the burden computerized documentation places on doctors. They are being tasked with greater data entry, and less with analysis and care. This goes beyond anecdotes.” To be sure, technology today creates new opportunities for Providers that simply did not exist in the past, not to mention the possibility of delivering superior medical care due to the accessibility of the information at hand. Notwithstanding, some architects of the proverbial cloud, including Amazon, Google and Microsoft, fail to embrace this technology in the way that federal and state laws mandate health care’s acquiescence. Only time will tell, however, if the cloud is ready for health care and its EHR requirements.
A warranty is an express or implied assurance from one party that what it promises in the contract will in fact be provided to the other party. An implied warranty is one that may be contractually binding, even if unstated, while an express warranty is set forth in the agreement. If parties prefer to avoid any implied warranties, a contract can always expressly disclaim them.
At times, Developer contracts may include an express warranty, but only as it relates to the Developer’s “then current” technology. Understanding a transaction’s “then current” status is challenging, yet critical for both sides. Providers should review the documentation to identify which provisions refer to and determine the technology needed at the time the parties enter into an agreement, at least to the extent the Provider desires an express warranty. As an extra measure of protection, a Provider may want to include language that protects against any adverse impact from future changes and technology, or states that these same changes down the road will not retroactively compromise the express warranty in place. Rather than predicting future technology, however, a sound practice should be the inclusion of all material specifications, initial Developer proposals and Provider needs, leaving nothing to chance outside the four corners of the final agreement.
“Meaningful Use” is part of the foundation for most agreements between Developer and Provider. Standard terminology in Developer contracts designed to identify Provider eligibility for participation in Medicare and Medicaid EHR Meaningful Use Incentive Programs should always include an express warranty covering meaningful use certification for the present, as well as the necessary and appropriate future modifications required by federal law. If a Developer is not willing to expressly warrant for meaningful use, Providers must determine the Developer’s status for certifying the same. Providers should be cautious when a Developer expressly certifies Meaningful Use at the time the parties enter into an agreement but refuses to make any representations for the future. With no future warranties, a change in the Developer’s system that results in a loss of certification, or perhaps even the loss of the Developer, will create sizable challenges for any Provider. Planning for such an event can be even more complicated, especially if the Developer cannot provide price information on the cost to comply with that which is unknown.
“Terms set forth in a writing intended by the parties as a final expression of their agreement with respect to the terms included therein may not be contradicted by evidence of a prior agreement or of a contemporaneous oral agreement.” This standard integration clause language, common in most agreements, “vitiates” any and all promises and representations made before the parties agreed to contract.
Irrespective of what was discussed in the past, the inclusion of similar language effectively ensures that the agreement is all that really matters from this point forward. While this applies to the “four corners” of the agreement between Provider and Developer, Providers should always make sure the acquisition is comprehensive enough to address all facets of EHR and that it communicates directly with the surrounding digital landscape from where the Provider is expected to make Meaningful Use of its EHR. Anything less than such a demand may defeat the very purpose for the software.
A limitation of liability clause is a provision that limits the financial risk a company faces in the event of a lawsuit usually by placing limits on the amount of potential damages a company may be required to pay. In an EHR contract, Providers should be reluctant to limit the liability for the Developer, either with monetary caps on payout obligations or by excluding consequential and other special damages so that the Developer is only liable for direct damages.
Before signing any agreement, Providers should determine if the Developer has set a maximum dollar amount for liability. If there is maximum dollar threshold, Providers should analyze how this amount could impact business under different scenarios. Rather than limiting liability based on a dollar amount, Providers may consider liability limitations in terms of possible categories of damages, although it is difficult to waive liability for direct damages (arising from costs incurred as a result of a party’s breach). A Developer typically will seek to avoid liability for consequential damages, which are damages that result on account of the breach, such as lost profits or damage to reputation.
It is never too soon for a Provider to think about the end, or at least the end of an agreement with a Developer. Continuous access to patient records is critical for almost all practices, and equally important is the language in an agreement addressing a possible transfer of information from one EHR system to another. It is also important that the operative business associate addendum includes a provision that ensures the return or destruction of all protected health information. While Providers would be prudent to demand the return of their own information, at a minimum they must ensure there is no compromise on the integrity of that information.
Ambulatory setting only. The reason for referral; and referring or transitioning provider’s name and office contact information.
Providers are like shepherds, only guarding medical records instead of sheep. With an appropriate BAA in place between Providers and Developers, the collection of the medical records at the conclusion of the agreement should resemble the return or destroy language in most BAAs. It is important that Providers preserve the default provisions of a BAA in agreements with Developers, and even more important that the Developers comply.
Health Level Seven Clinical Document Architecture (CDA) Release 2, Continuity of Care Document (CCD) (incorporated by reference in § 170.299). Implementation specifications. The Healthcare Information Technology Standards Panel (HITSP) Summary Documents Using HL7 CCD Component HITSP/C32 (incorporated by reference in § 170.299).
ASTM E2369 Standard Specification for Continuity of Care Record and Adjunct to ASTM E2369 (incorporated by reference in § 170.299).
HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, (incorporated by reference in § 170.299). The use of the “unstructured document” document-level template is prohibited.
HL7 Implementation Guide for CDA ® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Volume 1—Introductory Material, Release 2.1 and HL7 Implementation Guide for CDA ® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Volume 2—Templates and Supporting Material, Release 2.1 (incorporated by reference in § 170.299).
No matter how the relationship between Provider and Developer may end, it does not modify the EHR-related obligations on the part of the Provider. Even as the standards evolve, Provider compliance is not optional. As important as termination and wind down may be for the Provider, it is only a transition. The ease with which a Provider can move from one Developer to another depends on the Developer agreement, not to mention the condition of the Provider’s information upon retrieval from the system, assuming the information the Provider can retrieve exists in a usable format. Outright denial by a Developer, of course, creates an entirely added level of complexity for the Provider, although strict adherence to federal law in drafting business associate agreements should prevent such an unpleasant result. Ultimately, Providers must retrieve patient information in an accessible format upon termination of the agreement. “Portability” (another term from “HIPAA”) remains critical. Knowing in advance the cost and timing for such a transition is also an important item to negotiate before entering into an agreement with a Developer. and Providers should always be mindful that business stability upon termination is critical.
The dispute resolution provisions within an EHR contract are integral to avoid any disruption in patient care and business operations. To determine the best option for Providers, consider what is available, and how implementation would occur. Providers should be mindful that during a dispute the need to maintain an EHR system most likely remains. The costs of replacement or disruption of services, however, may be more challenging and expensive than the dispute itself. While alternative dispute resolution and arbitration in particular may be just as difficult to avoid as the underlying disagreement, the effectiveness of these options in litigation depend upon the speed with which a resolution may occur. Providers should not ignore the additional benefits to mediation, especially when the dispute involves sensitive business information or even PHI.
In passing California Senate Bill 945 in 2010, Medi-Cal can distribute one billion four hundred million dollars ($1,400,000,000) to Medi-Cal providers over the next 10 years for EHR support purposes. The federal and state commitments to wide scale implementation of EHR are unmistakably clear, but ultimate success depends upon the ways in which Providers and Developers interact to accomplish these objectives. Health care is a business, and for Providers to successfully participate in EHR implementation, they must focus on all salient provisions of any Developer agreement.
[C]ertain EHR technology features may be used to make true authorship of the medical record and distort information to inflate health care claims. The transition from paper records to EHRs may present new vulnerabilities and require the Centers for Medicare & Medicaid Services (“CMS”) and its contractors to adjust their techniques for identifying improper payments and investigating fraud.
More recently, the OIG urged the federal Office of Civil Rights to strengthen its oversight of the ways in which covered entities comply with the privacy standards under HIPAA as well as OCR’s follow up on reported breaches of patient health information.
B. When Things Go Wrong?
Monetary penalties notwithstanding, HIPAA and HITECH obligate Providers to mitigate the damage caused by privacy transgressions, including the use or disclosure of protected health information (“PHI”). Federal law also requires the Provider to give notice to each individual whose unsecured PHI has been disclosed due to a breach, or there is a reasonable belief of a disclosure. California’s Confidentiality of Medical Information Act (“CMIA”) also requires notification within 15 business days from identifying the breach.
In the past several years, the United States has spent billions of dollars to safeguard the gamut of health information, from broken bones to heart surgery to mental illness, all of which are protected by federal and state law from public disclosure. The OCR handled 109,722 HIPAA-related complaints registered between April 2003 and February 1, 2015. Private practices and acute care hospitals were among the worst offenders. When it comes to PHI and EHR, the law of our nation affords each and every patient is with strict confidentiality. The influence of HIPAA and HITECH on health care has changed its very infrastructure, protecting the disclosure of a broken finger equally as a diagnosis of iatrophobia.
Without Provider participation and cooperation, however, HIPAA and HITECH mean nothing. Failure by any Provider to follow the strict requirements of HIPAA and HITECH may result in loss of license, significant financial penalties, or both. To be sure, Providers have financial incentives to comply with HIPAA and HITECH, including Meaningful Use. To avoid penalties and enjoy the financial incentives of statutes and regulations relating to EHR, there will be a Developer agreement along the way, into which Providers must enter. Providers should be mindful that such agreements, although necessary, can be treacherous, and Providers must pay careful attention to all terms included therein, especially since HIPAA and HITECH are rather unforgiving.
 Craig is an attorney and health care consultant, specializing in issues surrounding modern American health care and the ways in which it should be managed in its current climate of reform. Craig’s law practice focuses on health care mergers and acquisitions, regulatory compliance and counseling for providers. Craig is also a Fellow of the American College of Healthcare Executives and an adjunct professor of law at Pepperdine University School of Law. Between 2002 and 2011, Craig was the Chief Executive Officer at Coast Plaza Hospital in Norwalk, CA.
 Jessica is an attorney specializing in health care law with a particular focus in regulatory compliance, business transactions and providing counsel to providers. Jessica is licensed to practice in both California and Ontario, Canada, a member of the California Society for Healthcare Attorneys, Los Angeles County Bar Association and the American Bar Association. Jessica is also a member of the Beth Tzedek New Leadership Council.
 Lewis Carroll, Through the Looking Glass and What Alice Found There at 16 (Macmillan 1871).
 This is one example from the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (also known as ICD-10). See infra n.11.
http://www.forbes.com/sites/roysmythe/2015/01/08/applying-aspects-of-complexity-theory-to-health-care-delivery-its-not-complicated/ (“[There is] no other ‘system’ that is more complex, or less predictable than health care.”).
http://www.forbes.com/sites/janetstemwedel/2015/08/23/the-philosophy-of-star-trek-the-kobayashi-maru-no-win-scenarios-and-ethical-leadership/. And of course there is Zugzwang, that moment in chess when the next move will unavoidably make things worse. Lasker’s Chess Magazine, at 105 (Feb. 1905).
 In addition to physicians, “[t]he term ‘health care provider’ includes a hospital, skilled nursing facility, nursing facility, home health entity or other long term care facility, health care clinic, community mental health center . . . renal dialysis facility, blood center, ambulatory surgical center . . . emergency medical services provider, federally qualified health center, group practice, a pharmacist, a pharmacy, a laboratory . . . a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe . . . a rural health clinic . . . a therapist . . . and any other category of health care facility, entity, practitioner, or clinician determined appropriate by the [HHS Secretary].” 42 U.S.C. § 300jj(3).
 See, e.g., William M. Thackeray, Vanity Fair: A Novel Without a Hero, Ch. 8 (Punch Magazine 1847-48).
 See 79 Fed. Reg. 67548, 67763 (Nov. 13, 2014).
 79 Fed. Reg. 40318, 40325 (July 11, 2014).
 See generally 74 Fed. Reg. 3328 (Jan. 16, 2009) (to be codified at 45 C.F.R. pt. 162). ICD-10 applies for reimbursement claims with a date of service on or after October 1, 2015. See id.
 See M.F. Furukawa, J. King, J., V. Patel, C.J. Hsiao, J. Adler-Milstein and A.K. Jha, Despite Substantial Progress In EHR Adoption, Health Information Exchange and Patient Engagement Remain Low in Office Settings, Health Affairs, 33 (9), 1672-79 (2014).
(iv) to exchange electronic health information with, and integrate such information from other sources.” 42 U.S.C. § 300jj (13).
 Exec. Order No. 13335, 69 Fed. Reg. 24059 (Apr. 27, 2004).
 See Michael J. Daray, Esq., Negotiating Electronic Health Record Technology Agreements, 22 No. 2 Health Lawyer 53 (Dec. 2009). By 2009, an estimated 30 to 70% of EHR deployments failed. Id.
 See 80 Fed. Reg. 62762, 62765 (Oct. 16, 2015) (final rule) (“The Stage 1 final rule established the foundation for the Medicare and Medicaid EHR Incentive Programs by establishing requirements for the electronic capture of clinical data, including providing patients with electronic copies of their health information. [¶] [Stage 2] focused on the . . . exchange of essential health data among health care providers and patients to improve care coordination [and] finalized a set of clinical quality measures (CQMs) that all providers participating in any stage of the program” must report to CMS. Stage 3 built on the groundwork of both earlier stages, and “focuses on the advanced use of EHR technology to promote improved patient outcomes and health information exchange.” See also 80 Fed. Reg. 20346 (Apr. 15, 2015) (proposed rule).
 See 80 Fed. Reg. 62602, 62603-62604 (Oct. 16, 2016) (final rule) (making the ONC Health IT Certification Program more accessible to other types of health IT and not just EHR, including the technology of health information service providers (“HISPs”) and health information exchanges (“HIEs”) so that they can “receive appropriate attribution and not be referenced by a certificate with ‘EHR’ included in it”).
 Medicare Access and CHIP Reauthorization Act of 2015, Pub. L. 114-10, amending 42 U.S.C. § 1395w-4(o)(2).
 Office of the National Coordinator for Health Information Technology Federal Health IT Strategic Plan (2015-2020) at p. 5 (2015).
http://www.wsj.com/articles/jeffrey-a-singer-obamacares-electronic-records-debacle-1424133213; Catherine M. DesRoches, Dr.P.H., Eric G. Campbell, Ph.D, et al., Electronic Health Records in Ambulatory Care – a National Survey of Physicians, 359 N. Engl. J. Med. 50 (July 3, 2008).
 See 42 C.F.R. § 1001 (promulgating regulations to create an “Electronic Health Records Safe Harbor” Under the Anti-Kickback Statute).
 See, e.g., Sharona Hoffman and Andy Podgurski, E-Health Hazards: Provider Liability and Electronic Health Record Systems, 24 Berkeley Tech. L. J. 1523 (Fall 2009).
 See, e.g., E.L. White, Inc. v. City of Huntington Beach, 21 Cal. 3d 497, 510 (1978) (noting that indemnity has been defined as “the obligation resting on one party to make good a loss or damage another has incurred.”).
 See, e.g., Cal. Civ. Code § 1605 (good consideration defined).
 See, e.g., Cal. Civ. Code § 3529 (“That which ought to have been done is to be regarded as done, in favor of him to whom, and against him from whom, performance is due.”).
 See Cal. Civ. Code § 2860.
 See, e.g., Myers Bldg. Indus., Ltd. v. Interface Tech., Inc., 13 Cal. App. 4th 949, 968 (1993) (“An indemnity agreement is to be interpreted according to the language and contents of the contract as well as the intention of the parties as indicated by the contract.”).
 But see Miller v. Ellis, 103 Cal. App. 4th 373, 380 (2002) (holding equitable indemnification is not automatically available, but rather at times is a decision for the Court to make).
 For the rules of interpretation of a contract of indemnity, see Cal. Civ. Code § 2778.
 See, e.g., Rooz v. Kimmel, 55 Cal. App. 4th 573, 583 (1997). “When the parties knowingly bargain for the protection at issue, the protection should be afforded.” Id. at 583 (quoting Rossmoor Sanitation, Inc. v. Pylon, Inc., 13 Cal. 3d 622, 633 (1975)).
 See, e.g., Cal. Com. Code § 2312. The taxing authorities, at least, understand this tenet. See Cal. Rev. & Tax Code § 6011(c)(10)(D).
 See e.g., Lim v. The TV Corp. Int’l, 99 Cal. App. 4th 684 691 (2002).
 See generally Lugosi v. Universal Pictures, 25 Cal. 3d 813 (2007) (lawsuit by the widow of Bela Lugosi claiming violation of her intellectual property right to the Dracula character).
 See e.g., Rossmoor Sanitation, Inc. v. Pylon, Inc., 13 Cal. 3d 622, 628 (1975). Insurance, too, is also useful should licensing issues arise, although contractual indemnity claims prevail over “theoretical noncontractual rights of indemnification between insureds.” Id. at 634.
 See e.g., Buss v. Superior Ct., 16 Cal. 4th 35, 45-46 (1997) (The insurer’s duty to indemnify runs to claims that are actually covered, in light of the facts proved. . . . By definition, it entails the payment of money in order to resolve liability.”).
 See, e.g., Altavion, Inc. v. Konica Minolta Sys. Lab. Inc., 226 Cal. App. 4th 26, 37 (2014).
 Grail Semiconductor, Inc. v. Mitsubishi Electric & Electronics USA, Inc., 225 Cal. App. 4th 786, 800 n.12 (2014).
 See, e.g., Pettus v. Cole, 49 Cal. App. 4th 402, 426 (1996).
 See generally Sheppard v. Lightpost Museum Fund, 146 Cal. App. 4th 315 (2006).
 See, e.g., Cassel v. Superior Ct., 51 Cal. 4th 113, 126-27 (2011).
 See, e.g., Sanchez v. County of San Bernardino, 176 Cal. App. 4th 516. 525 (2009).
 The importance of a business associate addendum should not be forgotten for “any health care provider who transmits any health information in electronic form in connection with a transaction.” 45 C.F.R. § 164.104. The logistical requirements, however, are not always simple and can involve a multitude of variables, all of which create challenges on their own. See 45 C.F.R. § 164.530.
 “It is a widely accepted myth that medicine requires complex, highly specialized information technology (IT) systems. This myth continues to justify soaring IT costs, burdensome physician workloads, and stagnation in innovation – while doctors become increasingly bound to documentation and communication products that are functionally decades behind those they use in their ‘civilian’ life.” Kenneth D. Mandl, M.D., M.P.H., and Isaac S. Kohane, M.D., Ph.D., Escaping the EHR Trap – The Future of Health IT, 366:24 N. Eng. J. Med. 2240 (June 14, 2012).
 See, e.g., “Cloud Computing: An Overview Standard Medicine Information Resources & Technology, available at https://med.stanford.edu/irt/security/cloud.html (“Before cloud storage existed, in order to provide storage to users an organization would need to: purchase the storage; create a data center where the storage would reside; run servers that would utilize the storage; and employ server administrators, storage experts and data center operators. Today, an organization or even an individual can have the equivalent of a data center’s infrastructure, just by using a cloud-based service. It can potentially save thousands of dollars and man-hours, and might even be completely free while being available 24/7. But there are security issues that must be addressed before these services can be verified as truly secure, including data ownership, data separation, data protection, and backup.”).
http://www.wsj.com/articles/cloud-computing-kingpins-slow-to-adapt-to-own-movement-1438731775 (“This market, combined with some other cloud services, has grown from $10.5 billion in 2013 to $19.9 billion this year. . . . It is projected to be worth $26.5 billion in 2016.”).
 See, e.g., Mega RV Corp. v. HWH Corp., 225 Cal. App. 4th 1318, 1334-35 (2014).
 See, e.g., Cal. Com. Code § 2314 (implied warranty; merchantability; usage of trade); Cal. Com. Code § 2315 (implied warranty; fitness for a particular purpose).
 See, e.g., Cal. Com. Code § 2313 (express warranties by affirmation, promise, description, sample).
 See, e.g., Cal. Com. Code § 2316 (exclusion or modification of warranties); Delta Air Lines, Inc. v. Douglas Aircraft Co., 238 Cal. App. 2d 95, 101 (1965) (“The statutory implied warranties of quality can, of course, be disclaimed by the seller, provided the buyer has knowledge or is chargeable with notice of the disclaimer before the bargain is complete.”). But see generally International Knights of Wine, Inc. v. Ball Corp., 110 Cal. App. 3d 1001 (1980) (claims for fraud, negligent misrepresentation or strict liability may still exist after a disclaimed warranty).
 See, e.g., In re Sony Grand Wega KDF-E A10/A20 Series Real Projection HDTV Television Litigation, 758 F. Supp. 2d 1077, 1090 (U.S.D.C. S.D. Cal. 2010).
 See, e.g., Amtower v. Photon Dynamics, Inc., 158 Cal. App. 4th 1582, 1609 (2008) (“The purpose of an integration clause is to preclude the introduction of evidence which varies or contradicts the terms of the written instruments. [citations omitted] It does not function to meld the documents it mentions.”); cf. supra n. 59.
 See 45 C.F.R. § 170.314 (certification criteria for Complete EHRs or EHR Modules effective January 14, 2016).
 This can be done by accessing the following Website maintained by the Office of the National Coordinator for Health Information Technology: http://oncchpl.force.com/ehrcert. For more information about the Office of the National Coordinator for Health Information Technology, see 42 U.S.C.A. § 300jj-11.
 See, e.g., In re Manville Forest Products Corp., 209 F.3d 125, 129 (2nd Cir. 2000).
 Cal. Civ. Proc. Code § 1856(a).
 See, e.g., Cal. Civ. Code § 2176.
 See, e.g., McCarn v. Pacific Bell Directory, 3 Cal. App. 4th 173, 181-82 (1992).
 See Cal. Com. Code § 2715. Developers may also try to exclude “lost data” from damages, see, e.g., Ward General Ins. Services, Inc. v. Employers Fire Ins. Co., 114 Cal. App. 4th 548, 559 (2003), although such a provision could subject a Provider to different kinds of liability. See, e.g., Robert F. Kennedy Med. Ctr. v. Belshe, 13 Cal. 4th 748, 751-52 (1996).
 See, e.g., 22 C.C.R. § 72534.
 45 C.F.R. § 164.504(e)(2)(ii)(J); see also 42 C.F.R. 164.502(a)(3): (“Business associates: Permitted uses and disclosures. A business associate may use or disclose protected health information only as permitted or required by its business associate contract or other arrangement pursuant to § 164.504(e) or as required by law. The business associate may not use or disclose protected health information in a manner that would violate the requirements of this subpart, if done by the covered entity, except for the purposes specified under § 164.504(e)(2)(i)(A) or (B) if such uses or disclosures are permitted by its contract or other arrangement.”).
 Exec. Order No. 13181, 65 Fed. Reg. 81321 (Dec. 20, 2000), § 2, Pt. (b).
 See 45 C.F.R. § 170.205 (effective through and including Jan. 13, 2016 as well as on and after Jan. 14, 2016).
 See 45 C.F.R. § 170.205 (effective Jan. 14, 2016).
 As part of CMS’ conditions of participation for hospitals, the medical records for each inpatient and outpatient must be “accurately written, promptly completely, properly filed and retained, and accessible.” 42 C.F.R. § 482.24(b) (emphasis added); see also Cal. Health & Safety Code § 1250.05(d)(“All general acute care hospitals . . . shall develop and implement policies and procedures to ensure that relevant portions of patient’s medical records can be made available within a reasonable period of time. . . .”).
 Historically the focus of courts in part was determination of constructive possession or actual control. See, e.g., Ashton v. Burke, 83 B.R. 716, 724 (D.N.D. 1988).
 See 42 C.F.R. § 164.504(e)(2)(ii)(J) (“At termination of the contract, if feasible, return or destroy all protected health information received from, or created or received by the business associate on behalf of, the covered entity that the business associate still maintains in any form. . . .”); but see Medassets Net Revenue Systems, LLC v. Downey Regional Medical Center, 2014 WL 1607633, *13 (C.D. Cal. 2014) (“But HIPPA [sic] does not create an independent duty. Rather, § 164.504(e) sets forth assurances that covered entities must include in a written contract.”).
 See, e.g., Thomas J. Stipanowich, Arbitration and Choice: Taking Charge of the “New Litigation”, 7 DePaul Bus. & Com. L.J. 383 (Spring 2009).
 See, e.g., Steven L. Schooner, Fear of Oversight: The Fundamental Failure of Businesslike Government, 50 Am. U. L. Rev. 627 (Feb. 2001).
 See Cal. Civ. Proc. Code § 1281 (validity of enforcement of arbitration provisions); Cal. Civ. Proc. Code § 1141.11(a) (“[A]ll nonexempt unlimited civil cases shall be submitted to arbitration under this chapter if the amount in controversy, in the opinion of the court, will not exceed fifty thousand dollars ($50,000) for each plaintiff”); but see Cal. Civ. Proc. Code § 1775.4 (the court cannot force parties into mediation where the action was ordered into arbitration pursuant to Section 1141.11(a), nor can a mediation pursuant to Section 1775.3 be forced into arbitration).
 See, e.g., Lappe v. Superior Ct., 232 Cal. App. 4th 774, 783 (2014) (discussing the broad mediation privilege in California). Such an expansive mechanism for confidentiality exists in stark contrast to the challenges keeping records confidential in court. See, e.g., Huffy Corp. v. Superior Ct., 112 Cal. App. 4th 97, 106 (2003) (court disregarded an agreement not to disclose for failure to show prejudice). This also applies to divorce proceedings. Burkle v. Burkle, 135 Cal. App. 4th 1045, 1070 (2006).
 S.B. 945, 2011 Cal. Legis. Serv. Ch. 433 (Oct. 2, 2011) (repealing parts of the Cal. Welfare and Institutions Code, including Section 14046).
 Id. These funds are made available through the American Recovery and Reinvestment Act of 2009, § 4201 (Pub. L. 111-5).
 Cf. Beverly Cohen, The Controversy Over Hospital Charges to the Uninsured – No Villains, No Heroes, 51 Vill. L. Rev. 95, 146 n. 316 (2006).
 See Generally U.S. Office of the Inspector Gen., OEI-01-11-00571, CMS and Its Contractors Have Adopted Few Program Integrity Practices to Address Vulnerabilities in EHRs (Jan. 2014), available at http://oig.hhs.gov/oei/reports/oei-01-11-00571.pdf.
 Id. at 1. Two examples noted by the OIG include federal guidance on electronic signatures in EHRs and audit logs to authenticate the medical records supporting a claim. Id. at p 13.
 HHS has designated the OCR as the primary agency to enforce the Privacy Rule. See, e.g., Protection & Advocacy System, Inc. v. Freudenthal, 412 F. Supp. 2d 1211, 1217 (D. Wyo. 2006). OCR oversees complaints relating to HIPAA, and more specifically those 109,722 HIPAA-related complaints registered between April 2003 and February 1, 2015. Of these potential HIPAA infractions, approximately 70% did not fall within OCR jurisdiction or the OCR determined no violation had occurred. But in some 40,000 cases investigated by the OCR, 30% found no violation, while 70% required some corrective action, usually in reference to impermissible uses and disclosures of PHI, failure to keep PHI safe, lack of patient access to PHI, or disclosure of more information than was reasonably necessary. Private practices and acute care hospitals were among the worst offenders. See generally Craig B. Garner, HIPAA — Society’s Modern Day Prohibition (Ca. Healthcare News, May 2015), available at http://www.cahcnews.com/newsletters/ca-cgarner-0615.pdf.
 See generally Office of Inspector Gen., OEI-09-10-00510, OCR Should Strengthen Its Oversight of Covered Entities’ Compliance with the HIPAA Privacy Standards at 11-12 (Sept. 2015) (recommending that OCR (1) strengthen its oversight of covered entities compliance with the Privacy Rule; (2) improve its investigation process; (3) fully implement a permanent audit program; (4) carefully track corrective action; (5) identify previous investigations against providers; and (6) continue to educate covered entities about OCR and the privacy standards.
 Office of Inspector Gen., OEI-09-10-00511, OCR Should Strengthen its Follow up of Breaches of Patient Health Information Reported by Covered Entities at 13-14 (Sept. 2015) (recommending that OCR (1) maintain information regarding small breaches in a searchable format; (2) maintain complete documentation of corrective actions; (3) expand outreach and education efforts; and (4) check for prior breaches by covered entity).
 For purposes of HIPAA, of concern are data breaches where information is not just lost but also used or abused. See, e.g., In re Science Applications International Corp. (SAIC) Backup Tape Data Theft Litigation, 45 F. Supp. 3d 14, 20 (D.D.C. 2014). The idea of a data breach, however, is not always objective. For example, identify theft is “the unauthorized use of another person’s personal identifying information to obtain credit, goods, services, money, or property.” See Cal. Civ. Code § 1798.92(b). PHI is individually identifiable health information maintained by a covered entity, such as a hospital. See 45 C.F.R. § 160.103. The perpetrator of identity theft can also be the “owner” of PHI, even if admitted to a hospital under the name of the victim. The perpetrator should not be confused, however with the victim of identify theft, or “a person who had his or her personal identifying information used without authorization by another to obtain credit, goods, services, money, or property, and did not use or possess the credit, goods, services, money, or property obtained by the identity theft, and filed a police report in this regard pursuant to Section 530.5 of the Penal Code.” Cal. Civ. Code § 1798.92(d).
 For a list of all federal civil money penalties, see 45 C.F.R. § 160.404. For additional information about California penalties, see generally Cal. Civ. Code § 56.101; but see Sutter Health v. Superior Court, 227 Cal. App. 4th 1546, 1564 (holding that the loss of an unencrypted computer alone was “not a breach of confidentiality” when a thief stole an unencrypted desktop computer from Sutter Health containing the personal information of over 4 million patients).
 “Reasonable diligence refers to the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances.” 45 C.F.R. § 160.401.
 “Reasonable cause means an act or omission in which a covered entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.” Id.
 “Willful neglect refers to conscious, intentional failure or reckless indifference to the obligation to comply with the administrative simplification provision violated” Id.
 45 C.F.R. § 164.308(a)(6); 45 C.F.R. § 164.530(f).
 42 U.S.C. § 17932(a). If only a handful of individuals are affected, notice should be mail or other comparable communication. 45 C.F.R. § 164.404. If a breach involves more than 500 individuals, notification must be made through the media outlets in the area, see 45 C.F.R. 164.406(a), as well as to the Secretary for HHS. 45 C.F.R. § 164.408.
 Cal. Health & Safety Code § 1280.15(b).
 See, e.g., Roger Hsieh, Improving HIPAA Enforcement and Protecting Patient Privacy in a Digital Healthcare Environment, 46 Loy. U. Chi. L.J. 175 (Fall 2014).
 See supra n. 86; see also http://www.hhs.gov/ocr/privacy/hipaa/enforcement/index.html.
 See Erin McCann, HIPAA data breaches climb 138 percent, Healthcare IT News (Feb. 6, 2014), available at http://www.healthcareitnews.com/news/hipaa-data-breaches-climb-138-percent.
 See, e.g., 15 C.C.R. § 3361(c)(“Recognizing that mental health care often involves revealing deeply personal and private matters, all mental health care shall be provided in such a manner as to maintain the dignity of the inmate. Professional relationships shall be conducted with proper privacy, with due regard to the professional to take necessary and appropriate action to prevent harm to the patient or to others.”).
 See 45 C.F.R. § 160.103 (“Protected health information means individually identifiable health information: (1) Exempt as provided in paragraph (2) of this definition [educational records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. § 1232.g], that is: (i) transmitted by electronic media; (ii) Maintained in electronic media; or (iii) Transmitted or maintained in any other form or medium.”). In matters of health care records, however, not all records, nor data breaches, are created equal. But see 15 C.C.R. § 3361(c)(“Recognizing that mental health care often involves revealing deeply personal and private matters, all mental health care shall be provided in such a manner as to maintain the dignity of the inmate. Professional relationships shall be conducted with proper privacy, with due regard to the professional to take necessary and appropriate action to prevent harm to the patient or to others.”).
 See 42 U.S.C. §§ 1320-d(5)(a)(1) through 1320-d(6)(a)(2); Diment v. Cushing, 2007 WL 2344981, *2 (D.C.W.D. Va. 2007) (“HIPAA imposes civil and criminal penalties on a person who knowingly and illegally obtains or discloses ‘individually identifiable health information’ from or to another person.”).
 See, e.g., 42 C.F.R. § 495.104 (incentive payments to eligible hospitals); 42 C.F.R. § 496.102 (incentive payments to eligible professionals).
 See, e.g., 45 C.F.R. § 164.502; Through the Looking Glass, supra, n. 3 at 223 (“‘It’s too late to correct it,’ said the Red Queen: ‘when you’ve once said a thing, that fixes it, and you must take the consequences.’”).

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