H. BRENT BRENNENSTUHL, District Judge.
Before the Court is the motion of Defendants (collectively "Deaconess") for a protective order regarding Plaintiff's request to inspect Deaconess' electronic medical records, to have Deaconess provide her with an exact copy of those records in native-format and to allow access to Deaconess' electronic records system during the course of depositions (DN 19). The Plaintiff has responded at DN 21 and Deaconess has replied at DN 26.
Plaintiff is the Administratrix of the estate of Nicole Borum. Plaintiff contends that Borum attempted to harm herself in the aftermath of the end of a relationship. Following initial treatment at another hospital, she came under the medical care of Defendant Dr. Smith, who was employed by a Deaconess entity. The Plaintiff alleges that on Borum's second visit, Dr. Smith prescribed an antidepressant. On the third visit Dr. Smith doubled the prescription for a six-month supply and scheduled Borum's next visit a year in the future. Three weeks later Borum committed suicide. She was twenty-three. Plaintiff claims that the Defendants were negligent in failing to closely monitor Borum's condition notwithstanding a product warning that the medication could increase the risk of suicide in young adults and therefore close supervision was required.
Deaconess employs an electronic medical records ("EMR") system to maintain patient care records, utilizing a software system licensed by Epic Systems Corporation (DN 19). Plaintiff has described her discovery requests to Deaconess:
(DN 21 at PageID # 327).
Deaconess seeks protection under Fed. R. Civ. P. 26(c)(1). The rule provides that, upon a showing of good cause, a Court may issue an order "to protect a party or person from annoyance, embarrassment, oppression, or undue burden or expense."
Rule 26(b)(1), in turn, instructs that the permissible scope of discovery encompasses "any nonprivileged matter that is relevant to any party's claim or defense and proportional to the needs of the case, considering the importance of the issues at stake, the amount in controversy, the parties' relative access to relevant information, the parties' resources and the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit."
Plaintiff has requested an opportunity to conduct a direct inspection of Borum's medical records in electronic format on Deaconess' computer system. Deaconess advances several arguments in opposition to Plaintiff's request. The first point of opposition is that the requested inspection would require Plaintiff's attorneys or designated representatives to utilize Epic System's software to access the EMR. This, Deaconess argues, would be a violation of the software licensing agreement between Deaconess and designer Epic Systems. Moreover, Deaconess contends that permitting Plaintiff to utilize the software would be an unauthorized use of Epic's programming under the Computer Fraud and Abuse Act ("CFAA") and the Copyright Act of 1976 ("Copyright Act"). Deaconess also argues that Plaintiff's requests implicate restrictions under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. § 1320d et seq (HIPAA).
As a practical matter, Deaconess further contends that the Epic software has been updated several times since Borum received treatment and Deaconess now cannot present the EMR in the exact same manner. Finally, Deaconess argues that, because it has already provided the Plaintiff with a complete copy of Borum's medical records, and Plaintiff has not raised any issues with the completeness or accuracy of those records, there is no relevance to allowing Plaintiff to inspect those same records on Deaconess' EMR system.
Deaconess points out language in the software licensing agreement with Epic Systems which requires Deaconess to "limit access to the Program Property to those of Your employees or other Affiliate users who must have access to the Program Property [to carry out] Your Operations" (DN 19-1, p. 2, referencing DN 19-3, License and Support Agreement at § 11(c)(ii)). Deaconess notes that "affiliate users" are specifically limited in the agreement to individuals and entities involved in its business operations (DN 19-1, p. 2 fn. 1). As such, Deaconess contends that the licensing agreement prohibits any use of Epic System's software for any reason other than patient care and billing purposes, and to permit Plaintiff to utilize the system to explore Borum's EMR would violate that agreement and expose Deaconess to a claim by Epic Systems that it had breached the terms of the contract.
In support of its argument, Deaconess cites
The Plaintiff responds that federal courts "have broad authority to issue orders governing litigation and discovery, and are not limited by the terms and conditions of private contracts" (DN 21, p. 23). She cites
The undersigned concurs with Plaintiff that
Similarly, another case cited by Deaconess,
Further, it is clear that drawing an analogy between allowing a confidentiality agreement to preclude discovery and allowing a contract to preclude discovery does not support Deaconess' position. Confidentiality clauses do not override a court's ability to order discovery. "Confidentiality clauses in private settlement agreements cannot preclude a court-ordered discovery pursuant to a valid discovery request."
A review of the licensing agreement (DN 19-3) makes clear that Epic Systems seeks to protect its software product in two ways. First, it seeks to ensure that the licensee will not utilize the product beyond the agreed scope for which it has paid the licensing fee, thereby protecting Epic System's commercial interest in the contract. Second, it seeks to protect its proprietary software information from public disclosure by allowing access only by the licensee, thereby protecting its commercial interest in the product. As to the first objective, allowing Plaintiff to view the EMR on the system as part of the discovery process does not jeopardize Epic System's commercial interest in the contract, as the use will be for litigation purposes and not delivery of healthcare services. Moreover, Deaconess has not offered any authority clearly supporting the proposition that, by virtue of contracting with a non-party, one party to the litigation can circumvent the rules of procedure and deprive the other litigation party of discovery to which it is otherwise entitled.
As to Epic System's confidentiality interest, where a party is obligated to protect confidential information which is otherwise discoverable the Court can accommodate the privacy interest while at the same time allowing the other party the discovery to which it is entitled under the civil rules by means of a protective order.
In addition to breaching the contract with Epic Systems, Deaconess contends that allowing the Plaintiff to access the EMR system would constitute a violation of the Computer Fraud and Abuse Act ("CFAA") and the Copyright Act of 1976 ("Copyright Act"). Deaconess also argues that Plaintiff's requests implicate HIPAA restrictions. None of Deaconess' arguments are availing.
First, Deaconess employs the CFAA (18 U.S.C. § 1032(a)(2)(C)) to support the idea that both Deaconess and the Plaintiff may be civilly and criminally liable should the Plaintiff gain access to the computer system. The cited provision provides that whoever intentionally accesses a computer without authorization or exceeds authorized access, and thereby obtains information from any protected computer may, under certain circumstances, face criminal liability. 18 U.S.C. §§ 1030(a)(2)(C), 1030(c).
The undersigned cannot locate any published or unpublished opinions from any federal (or state) court supporting a theory that accessing a computer as part of civil discovery violates the CFAA. This is because a court order grants authorized access to the relevant information, and unless the Plaintiff intentionally exceeded the access authorized, there could be no plausible claim under the CFAA. "The CFAA protects people from unauthorized access to computers, for example by hacking or stealing a password."
Similar reasoning applies to the Defendant's concerns that allowing Plaintiff access to its computer system may violate the Copyright Act. In short, such concerns are simply untenable in the discovery process, assuming the discovering party does not exceed the authority granted by the Court. Analogous arguments have been offered and rejected on numerous occasions. The following list is far from complete but demonstrates courts' apparent unanimity on this issue. See e.g.
Deaconess next argues that granting Plaintiff's requests could cause one or both parties to run afoul of regulations under HIPAA. While the parties spend a good amount of time arguing this point, it isn't particularly relevant to this Court's consideration. HIPAA is complex legislation intended to ensure the privacy of any medium of information gathered by a covered entity during a patient's treatment. 42 U.S.C. § 1320d. The Department of Health and Human Services has promulgated regulations to assist patients and covered entities in interpreting HIPAA. See generally 45 C.F.R. § 164.500 et seq. The regulations provide that covered entities are not subject to HIPAA's requirements when acting pursuant to a court order or as part of an administrative proceeding. 45 C.F.R. § 164.512(e)(1).
While few opinions have been written in this arena, a review of existing cases convinces this Court that HIPAA should not obstruct the operation of the Federal Rules of Civil Procedure. See e.g.
Having concluded that there are no statutory or contractual barriers, the undersigned turns to relevance and proportionality. The medical record is of course relevant to Plaintiff's claim that Dr. Smith was negligent in her treatment of Ms. Borum. Moreover, because Plaintiff claims that Deaconess was negligent in the management of its physician practice (DN 21 at PageID # 326-27), Plaintiff has demonstrated that the EMR system may be relevant as well. On the other hand, allowing Plaintiff to depose Dr. Smith while accessing the EMR system for the purpose of questioning her about her use of the software at the time of Plaintiff's treatment is unduly burdensome. Dr. Smith is being deposed about her care and treatment of Ms. Borum, not the EMR system. And, while her facility to use the system may be relevant to her ability to provide care, Plaintiff can gain an understanding of those matters through questioning. The potential for harassing or burdensome questioning by attempting to force Dr. Smith to perform a step-by-step reenactment of how she used the system at the relevant time outweighs any additional information that might be gained from such a demonstration. See e.g.
However, to enable Plaintiff to thoroughly depose Dr. Smith and to develop a complete understanding of Ms. Borum's medical record as it exists within the EMR system, Plaintiff will be allowed to perform an in person inspection of her medical record on the system itself. Additionally, Plaintiff requests an exact electronic copy of her medical record in its native format as well as the audit trail. Deaconess contends this is technically impossible (DN 19 at PageID # 277-78). But Plaintiff suggests in her response that, to the extent it in fact is impossible to produce an exact electronic copy, she will settle for printouts of the entire audit trail (DN 21 at PageID # 339-40). The Court assumes that Deaconess would not misrepresent the technological limits of its EMR system, and therefore orders that it provide Plaintiff with a printout of the entire audit trail.
Defendants additionally seek protection from Plaintiff's request that Deaconess allow Plaintiff to inspect its EMR system by having Deaconess create a fictitious "test patient" so that Plaintiff could manipulate that patient's record. Defendants again argue that creating a test patient would run afoul of HIPAA (DN 29 at PageID # 278). Furthermore, the Defendants argue any probative value of such an inspection would be greatly reduced or distorted because the system has been upgraded several times since 2015. Defendants also claim that, depending on how much information Plaintiff wished populated about the test patient, creating such a record could require a great deal of time and IT resources. Finally, Defendants claim that, because the test patient, if created, would not be allowed to access certain records, the accuracy and value of the inspection is eroded even further.
In response, Plaintiff contends Deaconess' advertisements stating that it is one of the most tech savvy hospitals in the region bely its claims that creating a test patient is somehow burdensome or infeasible (DN 21 at PageID # 345-46). Plaintiff further argues that setting up test patients is likely a routine part of training new employees and a process with which Deaconess' technical support personnel are already familiar. Finally, Plaintiff argues it is inequitable to require Plaintiff to hire an expert when Plaintiff's counsel could experiment with the EMR system on site. And, Plaintiff notes that Deaconess has customized the Epic system for its own use, and the only way to learn of these customizations is to use the system.
This is another relatively unexplored issue. In fact, the undersigned has been unable to locate a single case discussing access to EMR systems by counsel for purposes of assessing their functionality. However, the cases discussed above where a party seeks to compel another party to reenact or demonstrate something during a deposition are useful comparisons. The Sixth Circuit has not addressed the issue of compelling demonstrations in a deposition, but courts possess broad discretion to direct discovery.
1. Defendants shall permit Plaintiff the opportunity to perform an on-site inspection of Plaintiff's EMR;
2. Defendants will provide Plaintiff a complete copy of Borum's EMR audit trail.
3. Defendants are not required to make the EMR system available during the deposition of Dr. Smith;
4. Defendants are not required to create a test patient in the EMR system for Plaintiff's experimentation.