HIPAA Compliance During Litigation and Discovery

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A HIPAA Compliance During Litigation and Discovery Safeguarding PHI and Avoiding Violations When Responding to Subpoenas and Discovery Requests THURSDAY, OCTOBER 16, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Nathan A. Kottkamp, Partner, McGuireWoods, Richmond, Va. Philip H. Lebowitz, Partner, Duane Morris, Philadelphia The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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5 HIPAA Compliance During Litigation and Discovery Thursday, October 16, :30 p.m. (ET) Noon 1: 30 p.m. (CT) 10 11:30 a.m. (PT) Presented by: Nathan A. Kottkamp, McGuireWoods LLP nkottkamp@mcguirewoods.com Philip H. Lebowitz, Duane Morris LLP Lebowitz@duanemorris.com

6 Health Insurance Portability and Accountability Act of 1996 ( HIPAA ) 6

7 What Kind of Information is Protected? Protected Health Information (PHI) is any information, including genetic information, whether oral or recorded in any form or medium, that: Is created or received by a health care provider, health plan, or health care clearinghouse; and Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. 7

8 Omnibus Final Rule On January 17, 2013, HHS released the Omnibus Final Rule ( Final Rule ) interpreting and implementing provisions of the HITECH Act Effective date: March 26, 2013 Compliance date: September 23, 2013 Revision date for certain existing business associate agreements: September 22,

9 Core Elements of HIPAA Unchanged The Privacy Rule establishes individuals privacy rights and addresses the use and disclosure of protected health information ( PHI ) by covered entities and business associates The Security Rule establishes requirements for protecting electronic PHI The Breach Notification Rule requires HIPAA covered entities and their business associates to provide notification following a breach of unsecured PHI The Enforcement Rule establishes both civil monetary penalties and federal criminal penalties for the knowing use or disclosure of PHI in violation of HIPAA 9

10 Key Changes to HIPAA Under Omnibus Final Rule Breach risk of harm standard replaced with more objective test Definition of business associate expanded to include entities that maintain or store PHI even if they do not view the PHI Subcontractors of business associates that use or disclose PHI are directly subject to HIPAA (regardless of if there is a BAA) Expansion of liability of business associates (and subcontractors, as applicable) under the Privacy Rule and the Security Rule Individuals have a right to obtain electronic copies of PHI upon request if the PHI is maintained electronically Individuals may restrict disclosures regarding treatment paid out-of-pocket, in full Notices of Privacy Practices must include additional information Easing of rules for PHI with respect to research, fundraising, and decedents Tightening of rules for marketing and sale of PHI GINA (Genetic Information Non-Disclosure Act of 2008) incorporated Enforcement rule expanded 10

11 What s Next? MORE, MORE, MORE Education Policies Monitoring Documentation Scrutiny Enforcement 11

12 Primary Methods of Obtaining Medical Records Pursuant to HIPAA Patient request 45 C.F.R (a)(1)(i) 45 C.F.R Patient authorization of third party 45 C.F.R (a)(1)(iv) 45 C.F.R Subpoena or other discovery order Court or administrative order Reminder: In all cases, must follow the more restrictive of HIPAA or applicable state law. 12

13 Patient Request for Medical Records Patients have the right to request copies of most medical records, whether in paper or electronic form Requestor must be patient, patient s parent or guardian, or caregiver (with patient s permission) Request must be made in writing Providers required to keep HIPAA records for six years (state law may require longer) In limited cases the provider may refuse the request (e.g., mentally ill patient at risk of self-harm) Potential more rigorous accounting of disclosures may be requested in future 13

14 Cignet Health of Prince George s County 14

15 Cignet Health of Prince George s County, MD- Landmark HIPAA Civil Monetary Penalty, February 4, 2011 The first-ever civil money penalty of $4.3 million Cignet violated 41 patients rights by denying them access to their medical records when requested between September 2008 and October The HIPAA Privacy Rule requires that a Covered Entity provide a patient with a copy of their medical records within 30 (and no later than 60) days of the patient s request. The CMP for these violations is $1.3 million. Cignet failed to cooperate with OCR s investigations of the complaints and produce the records in response to OCR s subpoena. Covered Entities are required under law to cooperate with the Department s investigations. The CMP for these violations is $3 million. 15

16 HIPAA and Litigation HIPAA permits disclosure for judicial or administrative proceedings In response to A court order or order of an administrative tribunal a subpoena, discovery request, or other lawful process Without court order, provider must receive satisfactory assurance that reasonable efforts have been made to ensure that the affected patient has been given notice; or Secure a qualified protective order Provider may disclose without court order by itself making reasonable efforts to provide notice to patient Citation: 45 C.F.R (e) ( Disclosures for Judicial and Administrative Proceedings ) 16

17 When patient is a party Patient is plaintiff and requests own records Patient and provider both parties Patient has placed medical condition in question waiver Still may need and can obtain authorization for provider to use records 17

18 Patient is a party but provider is not Opposing party seeks patient s medical records from non-party provider Typically through subpoena Provider should insist on patient authorization If not, inform patient of subpoena and obligation to produce records if subpoena not quashed Move to quash subpoena 18

19 HIPAA Authorization Describe information to be disclosed Who authorized to disclose Who authorized to receive Purpose of disclosure Expiration date or event Signed and dated by patient Must include statement re right to revoke, potential for disclosure by recipient 19

20 Statements Required for Effective Authorization The patient must affirm knowledge of: The right to revoke the authorization No conditioning of care, payment, or coverage on the authorization The potential for redisclosure Citation: 45 C.F.R (c)(2) 20

21 When patient(s) not a party Most difficult case May arise in variety of contexts Malpractice (records of all other patients who had this procedure) Business torts (records of all patients who were told disparaging comments) Contract claims (list of all patients treated in violation of non-competition agreement) Records of others bitten by neighbor s dog 21

22 Patient not a party If provider is a party Request for Production of Documents from adverse party Court Order If provider not a party Subpoena Court Order Could be seeking records of multiple patients 22

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24 Qualified Protective Orders Order of court or administrative tribunal OR stipulation that: No other disclosure or use for any purpose other than the litigation or proceeding for which the information was requested Return or destroy disclosed protected health information at the conclusion of the litigation or proceeding Citation: 45 C.F.R (e)(1)(ii)&(v) 24

25 Satisfactory Assurance regarding qualified protective order Provider must: Written statement from requesting party and documentation demonstrating Parties to dispute have agreed to a qualified protective order and have presented it to court OR The requesting party has requested a qualified protective order from the court Loophole? QPO is requested but not yet received. Best to get the order. Make its own reasonable efforts to notify patient or seek qualified protective order 25

26 Preparing Draft Qualified Protective Orders Be narrow or expansive depending on purpose Define who may review or have access to documents Specify that documents be labeled Confidential or similar If PHI is in electronic form, specify encryption requirement Include non-disclosure requirement Require Receiving Party to certify in writing the return or secure destruction at the conclusion of litigation of all proprietary information (including PHI) Seal the record 26

27 Subpoenas Provider needs satisfactory assurance of: Written notice to the patient Information about the case sufficient for raising an objection Time period for objection elapses (follow state law or court rules) Citation: 45 C.F.R (e)(1)(ii)(A)&(e)(1)(iii) 27

28 Satisfactory Assurance regarding providing notice to patient Written statement from requesting party and documentation demonstrating Requesting party made good faith attempt to provide written notice to patient The notice included sufficient information to permit patient to object The time for patient to raise objections 28

29 Satisfactory Assurance How do you know? Provider must: Receive satisfactory assurance from requesting party that reasonable efforts have been made to ensure that patient has been given notice of request Make its own reasonable efforts to notify patient or seek qualified protective order 29

30 And then you wait Patient must have time to object. Timing not set forth in HIPAA May be: State statute Court rules Case law Provider must obtain confirmation that: No objections filed OR All objections resolved in favor of disclosure 30

31 Various Exceptions Workers compensation cases HIPAA exception, see 45 C.F.R (1) HIV/AIDS information HIPAA silent but take note of applicable state law Mental health records Redisclosure limitations Psychotherapy notes Patient authorization required per 42 C.F.R (a)(2) Patient Safety 42 C.F.R (a)(3) 31

32 Drug and Alcohol Treatment Records Super strict requirements Patient s Express Written Authorization 42 C.F.R Name of program making disclosure Name of recipient Patient s name Purpose of disclosure How much and what kind of information Signature Date NOTE: Providers need to include redisclosure warning statement per 42 C.F.R Court order required after showing good cause 42 U.S.C. 290dd-2 and 42 C.F.R. Part 2, Subpart E (2.61 et seq.) 32

33 American Psychological Association Position APA position statement for psychologists (2006) Only two options for disclosure of records: Patient authorization Court order Under this rule, subpoena is not enough This is an ethics rule, not a legal rule 33

34 HIPAA Without Authorization Required by law (45 C.F.R (a)) Involving victims of abuse, neglect or domestic violence (45 C.F.R (c)) Law enforcement purposes (45 C.F.R (f)) NOTE: These disclosures must comply with and are limited by requirements of law 34

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36 Court Orders Caution: Provider must release only the patient records or information expressly authorized by the court order Court order may be used to obtain additional protection Ability to review and redact portions not relevant to litigation Right to attend deposition and object to use of portions of medical records Notice and review of records to be filed with Court to permit objection or redaction 36

37 Appeals of Discovery Orders Federal Court only Perlman doctrine Perlman v. U.S., 247 U.S. 7 (1918) a discovery order directed at a disinterested third party is treated as an immediately appealable because the third party presumably lacks a sufficient stake in the proceeding to risk contempt by refusing compliance Permits 3 rd parties to litigation opportunity for appeal before producing PHI records 37

38 HIPAA Loopholes Satisfactory assurance Not required to actually notify patient just make good faith effort Not required to obtain a qualified protective order just have presented to or requested from court And what about disclosure to requesting party? 38

39 HIPAA Preemption HIPAA supersedes contrary provisions of state law BUT state law providing more stringent protection of privacy not preempted Prohibits or restricts use or disclosure that would otherwise be permitted under HIPAA Narrows scope or duration, increases privacy protections OR Provides greater privacy protection 39

40 State Laws Physician-patient privilege Laws regarding confidentiality of medical records Patient s Bill of Rights State constitutional law 40

41 Physician-Patient Privilege May vary by state Information acquired in attending the patient Information communicated to physician by patient Information gathered by physician through examination Communications are privileged (i.e., exempt) from discovery, even if HIPAA would permit Physician-patient privilege often applies to hospital 41

42 State Laws Regarding Confidentiality of Medical Records Independent regulatory duty of hospital to maintain the confidentiality of medical records Reports and records of health authorities HIV-related information Records of mental health facilities Drug and alcohol abuse records Applicable to particular facilities Birth Centers Home health care agencies Long-term care facilities AND others 42

43 Patient s Bill of Rights Adopted by individual states Patient has right to have records treated as confidential except as otherwise provided by law Person admitted to hospital has right to privacy and confidentiality of records pertaining to treatment except as otherwise provided by law Records not to be released without patient s approval 43

44 Constitutional Right of Privacy Right of privacy of medical records Right to be let alone May be superseded by compelling state interest in information Such as non-identifying information regarding donor of tainted blood 44

45 Serious Consequences Rost v. State Board of Psychology (1995) Psychologist subject to disciplinary action for releasing records per subpoena At the time Rost released records, she did not seek the consent of her client, professional legal advice or the imprimatur of a judge Compares privilege with code of ethics 45

46 Responding to Authorization or Subpoena Know state law requirements Confirm jurisdiction State law applies to federal court subpoenas Out-of-state subpoena may be honored under the Uniform Foreign Depositions Act but check state law Be a stickler for the rules Follow the time requirements These will be determined by state law Even when a request is proper, provide only the minimum necessary amount of information to satisfy the request or subpoena 46

47 Virginia s Magic Language NOTICE TO HEALTH CARE ENTITIES A COPY OF THIS SUBPOENA DUCES TECUM HAS BEEN PROVIDED TO THE INDIVIDUAL WHOSE HEALTH RECORDS ARE BEING REQUESTED OR HIS COUNSEL. YOU OR THAT INDIVIDUAL HAS THE RIGHT TO FILE A MOTION TO QUASH (OBJECT TO) THE ATTACHED SUBPOENA. IF YOU ELECT TO FILE A MOTION TO QUASH, YOU MUST FILE THE MOTION WITHIN 15 DAYS OF THE DATE OF THIS SUBPOENA. YOU MUST NOT RESPOND TO THIS SUBPOENA UNTIL YOU HAVE RECEIVED WRITTEN CERTIFICATION FROM THE PARTY ON WHOSE BEHALF THE SUBPOENA WAS ISSUED THAT THE TIME FOR FILING A MOTION TO QUASH HAS ELAPSED AND THAT: NO MOTION TO QUASH WAS FILED; OR ANY MOTION TO QUASH HAS BEEN RESOLVED BY THE COURT OR THE ADMINISTRATIVE AGENCY AND THE DISCLOSURES SOUGHT ARE CONSISTENT WITH SUCH RESOLUTION. IF YOU RECEIVE NOTICE THAT THE INDIVIDUAL WHOSE HEALTH RECORDS ARE BEING REQUESTED HAS FILED A MOTION TO QUASH THIS SUBPOENA, OR IF YOU FILE A MOTION TO QUASH THIS SUBPOENA, YOU MUST SEND THE HEALTH RECORDS ONLY TO THE CLERK OF THE COURT OR ADMINISTRATIVE AGENCY THAT ISSUED THE SUBPOENA OR IN WHICH THE ACTION IS PENDING AS SHOWN ON THE SUBPOENA USING THE FOLLOWING PROCEDURE: PLACE THE HEALTH RECORDS IN A SEALED ENVELOPE AND ATTACH TO THE SEALED ENVELOPE A COVER LETTER TO THE CLERK OF COURT OR ADMINISTRATIVE AGENCY WHICH STATES THAT CONFIDENTIAL HEALTH RECORDS ARE ENCLOSED AND ARE TO BE HELD UNDER SEAL PENDING A RULING ON THE MOTION TO QUASH THE SUBPOENA. THE SEALED ENVELOPE AND THE COVER LETTER SHALL BE PLACED IN AN OUTER ENVELOPE OR PACKAGE FOR TRANSMITTAL TO THE COURT OR ADMINISTRATIVE AGENCY. Citation: Va. Code :03 47

48 Tips Know your state statutes and local rules, and follow the more restrictive rule Careful drafting is crucial HIPAA requires minimum necessary disclosure Do not have paralegal sign requests or other subpoena documents Do not allow Business Associates to respond to subpoenas without at least providing notice Ensure your Business Associate Agreement contains appropriate language regarding the process to be followed when they receive a subpoena or Court Order 48

49 E-Government Act of 2002 Pleadings and court documents are going online Remove personal identifiers such as: Social security numbers Financial account numbers Dates of birth Names of minor children Check local rules for standards and compliance dates Citation: 42 U.S.C et seq. 49

50 Local Court Rules Be careful of local court rules about e-filings 50

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52 When HIPAA Does NOT Apply When PHI is received as a result of an authorization or subpoena But... State law may apply Common law liability principles may apply Professional ethics rules may apply 52