1 Comm. on Quality of Health Care in Am., Inst. of Medicine, To Err Is Human: Building a Safer Health System (Linda T. Kohn et al., eds. 1999) [hereinafter To Err is Human].

2 Id. at 31.

3 See id.

4 See Loewenbrück, Kai et al., Disclosure of Adverse Outcomes in Medicine: A Questionnaire Study on Voice Intention and Behaviour of Physicians in Germany, Japan and the USA, 30(3-4) German J. Human Res. Mgmt. 310, 311 (2016).Google Scholar

5 Loewenbrück, supra note 4, at 311-312 (noting that medical errors are responsible for more deaths than traffic accidents in Germany); See McMains, supra note 5 (citing a study published in The Boston Medical Journal, which relied on four separate studies that analyzed medical death rate date from 2000 to 2008 to extrapolate an annual estimate of deaths caused by medical errors in the U.S. based upon hospital admission rates from 2013); Hannah Nichols, The top 10 leading causes of death in the United States, Medical News Today (Feb. 23, 2017), https://www.medicalnewstoday.com/articles/282929.php (citing that accidents cause 136,053 deaths each year in the U.S.) [https://perma.cc/WNG4-4BXL]; See generally Klauber J, et al., KRANKENHAUS-REPORT 2014: SCHWERPUNKT: PATIENTENSICHERHEIT [Hospital Report 2014: Focus: Patient Safety] (Schattauer 2014), available at https://www.wido.de/fileadmin/wido/downloads/pdf_krankenhaus/krankenhaus-report/wido_kra_khr2014_kap1_0114.pdf (Ger.) (using extrapolation of data from international studies to estimate 18,800 deaths per year caused by medical errors in Germany); See generally BT 16/6339, ¶¶ 604-610, http://dipbt.bundestag.de/dip21/btd/16/063/1606339.pdf (Ger.) (finding that the systemic literature review conducted by the Research Unit of the Patient Safety Action Alliance, which extrapolated data from international studies was reliable and that the resulting estimated mortality rate -.01% of all hospital cases - was conservative.).

6 Mary Gregg, Creating a Culture of Improving Safety: Hospital Leaders Can Employ Four Key Communications Strategies for Moving the Needle in Patient Safety, Health & Hosp. Networks Daily (Oct. 24, 2013), https://www.hhnmag.com/articles/5793-creating-a-culture-of-improving-safety [https://perma.cc/NZ6D-A8UD].

7 See Loewenbrück et al., supra note 4, at 311-12.

8 See id. at 312-13.

9 See id.

10 See id.

11 See Netzwerk CIRSmedical.de, Ärztliches Zentrum für Qualität in der Medizin (ÄZQ) (Aug. 29, 2018), https://www.aezq.de/patientensicherheit/cirs/netzwerk-cirsmedical.de [https://perma.cc/TK7M-AZHB].

12 See Richard Kronick, AHRQ's Role in Improving Quality, Safety, and Health System Performance, 131(2) Pub. Health Reports 229-32 (2016).

13 Robin Osborn & Donald A. Goldmann, Piloting Health Care Delivery Innovations from Abroad: A Systematic Approach, The Commonwealth Fund (Nov. 27, 2017), https://www.commonwealthfund.org/blog/2017/piloting-health-care-delivery-innovations-abroad-systematic-approach. [https://www.commonwealthfund.org/blog/2017/piloting-health-care-delivery-innovations-abroad-systematic-approach.].

14 World Alliance for Patient Safety, Patient Safety: Making health care safer. 1 (World Health Organization 2017), http://www.who.int/patientsafety/publications/patient-safety-making-health-care-safer/en/.[ http://www.who.int/patientsafety/publications/patient-safety-making-health-care-safer/en/.].

15 See Loewenbrück et al., supra note 4, at 332.

16 Wagner, C., et al., Assessing patient safety culture in hospitals across countries, 25(3) Int J Qual Health Care 213, 219 (2013).CrossRefGoogle Scholar

17 See Loewenbrück et. al., supra note 4, at 313-314 (describing reasons for the “long-lasting tradition of silence embedded in the organizational culture of healthcare institutions”)

18 See id., at 313 (discussing the establishment of medicine); Liang, Chih-Ming, Rethinking the Tort Liability System and Patient Safety: From the Conventional Wisdom to Learning from Litigation, 12 Ind. Health L. Rev. 327, 348-49 (2015)Google Scholar (discussing the code of silence in medicine).

19 See generally Err is Human, supra note 1 (referencing the United States); Mohammad Bahrami, Amin, et al., Iranian Nurses' Perception of Patient Safety Culture, 16 Iran Red Crescent Med. J. 1 (2014)CrossRefGoogle ScholarPubMed (referencing Iran); Ghobashi, Maha Mohamed, Assessment of Patient Safety Culture in Primary Health Care Settings in Kuwait, 11 Epidemiology Biostatistics and Pub. Health 1901 (2014)Google Scholar (referencing Kuwait); Vitor Silva Mendonça & Eda Marconi Custódio, Being a Victim of Medical Error in Brazil: An (Un)Real Dilemma, 4 Health Psychol. Res. 38 (referencing Brazil); Radhakrishna, Subrahmanyan, Culture of blame in the National Health Service; consequences and solutions, 115 British J. of Anaesthesia 653 (2015)CrossRefGoogle ScholarPubMed (referencing the United Kingdom); Sibbald, Barbara, Ending the blame game key to overcoming medical error, 165 Canadian Med. Ass. J. 1083 (2001)Google ScholarPubMed (referencing Canada); Šklebar, Ivan, How to Improve Patient Safety Culture in Croatian Hospitals, 55 Acta Clinical Croatia 370 (2016)CrossRefGoogle ScholarPubMed (referencing Croatia); Freres, Martin & Walter, Cornelia, Behandlungsfehler im Krankenhaus: Offenlegen – entschuldigen – entschädigen [Treatment errors in hospitals: Disclose - apologize – compensate], 40 Dtsch Arztebl 1848 (2013)Google Scholar (Ger.) (referencing Germany).

20 E-mail from Günther Jonitz, Surgeon, President of the Berlin Chamber of Physicians, Founding Member of APS to author (Aug. 27, 2018, 11:50 GMT) (on file with the author) (citing Eliot Freidson, Profession of Medicine (1970); Don Berwick, Address at Patient Safety Global Action Summit in London (March 9-10, 2016) (“you must choose between fear and safety”).

21 See Loewenbrück, supra note 4.

22 See id. 4, at 317-318 (defining and scoring power distance, individualism, uncertainty avoidance, and masculinity), 323-326 (discussing findings regarding cultural influences on disclosure behavior).

23 Id. at 318.

24 Id. at 320 (discussing cultural tightness scores in the U.S. and Germany), 329 (discussing relationship between disclosure intention and disclosure behavior).

25 Loewenbrück, supra note 4, at 320 (“Japan belongs to the Confucian Asia cluster and is one of the tightest societies”), 329 (discussing relationship between disclosure intention and disclosure behavior).

26 Id. at 320 (defining cultural tightness).

27 See id. at 332.

28 Id. at 313.

29 Id.

30 Id.

31 Id. at 314

32 Id.

33 Id. at 314-315.

34 Id.

35 See id. at 312.

36 See Ratnapalan, Savithiri & Uleryk, Elizabeth, Organizational Learning in Health Care Organizations, 2 Systems 26, 26 (2014).CrossRefGoogle Scholar

37 WHO Draft Guidelines, supra note 10, at 10.

38 To Err is Human, supra note 1, at 4.

39 European Comm., Key findings and recommendations on Reporting and learning systems for patient safety incidents across Europe (European Comm. Patient Safety and Quality of Care working group 2014) (2014), http://ec.europa.eu/health/patient_safety/docs/guidelines_psqcwg_reporting_learningsystems_en.pdf; European Patients Forum, Briefing Paper on Patient Safety with a focus on the role of patients and families (European Patients Forum 2016) (2016), http://www.eu-patient.eu/globalassets/policy/patientssafety/patient-safety-briefing-paper.pdf.

40 See Sonja Barth, Aus Fehlern lernen –Schwachstellen im System rechtzeitig erkennen [Learn from errors - Identifying weaknesses in the system at an early stage] I Berliner Ärzte, 14 (2009) (F.R.G.); Günther Jonitz & Sonja Barth, Etablierung von Patientensicherheit – national und international [Establishment of Patient Safety – national and international] 15 Trauma Berufskrankh, 154, August 25, 2013 (F.R.G.), www.TraumaundBerufskrankheit.springer.de. [https://perma.cc/KS5B-ACRN].

41 Loewenbrück, supra note 4.

42 See id. at 313-14 (discussing barriers to voice in healthcare); Emily Hotton et al., BMJ Quality Improvement Rep., Improving Incident Reporting Among Junior Doctors 1 (2014); McClennan et al., supra note 25, at 23-24 (discussing barriers to open communication and disclosure practices); Souter, Karen J. & Gallagher, Thomas H., The Disclosure of Unanticipated Outcomes of Care and Medical Errors: What Does This Mean for Anesthesiologists?, 114(3) Anesthesia & Analgesia 615, 616-17 (2012)CrossRefGoogle ScholarPubMed; Wolf & Hughes, supra note 23, at 2-338-2-339 (discussing barriers to reporting in error reporting systems).

43 Loewenbrück et al., supra note 4, at 313-14.

44 Id. at 314. See Liang, Chih-Ming, Rethinking the Tort Liability System and Patient Safety: From the Conventional Wisdom to Learning from Litigation, 12 Ind. Health L. Rev. 327, 348-349 (2015)Google Scholar (discussing how the code of silence which is passed from generation to generation of physicians through medical training is largely responsible for resistance to patent safety initiatives).

45 Wolf & Hughes, supra note 49, at 2-339 (arguing that eliminating a punitive culture and institutionalizing a culture of safety is necessary to increase error reporting); Gisela Fischer, et al., CME-Concept “Patient Safety” Identify errors, Avoid incidents, Correct consequences 6 (Agency for Quality in Medicine 2009) http://www.aezq.de/mdb/edocs/pdf/literatur/ps-cme-2009.pdf (encouraging the development of a “culture of error and safety awareness” with the ultimate aim of increasing patient safety); To Err is Human, supra note 1, at ix (“a culture of blame must be broken down”), 14 (“healthcare organizations must develop a culture of safety”); see generally Khatri, Naresh, et al., From a Blame Culture to a Just Culture in Health Care, 34 Health Care Manage Rev. 312 (2009)CrossRefGoogle ScholarPubMed (defining blame culture as “a tendency within an organization not to be open about mistakes, suggestions and ideas, because of a fear of being individually held accountable for them”).

46 See generally Jonitz & Barth, supra note 47 (discussing the need to end the taboo topic of medical errors in the medical profession and focus on organizational learning); Barth, supra note 47 (noting that the individual blame for medical errors is a longstanding approach in medicine and that “patient safety” requires a more comprehensive approach that also focuses on organizational errors).

47 See Boothman, Richard C., CANDOR: The Antidote to Deny and Defend? 5 Health Services Research 2487, 2489 (2016)Google Scholar (arguing that transparency and honesty toward injured patients leads to an improved culture of safety); Barnes, et al., When Things Go Wrong: Responding to Adverse Events 3 (Massachusetts Coalition for the Prevention of Medical Errors 2006), http://www.macoalition.org/documents/respondingToAdverseEvents.pdf (“[O]pen discussion about errors can promote patient safety by encouraging clinicians to seek systems improvements that minimize the likelihood of recurrence.”).

48 See Phillips, Robert L. et al., The AAFP Patient Safety Reporting System: Development and Legal Issues Pertinent to Medical Error Tracking and Analysis, in 3 Advances in Patient Safety: From Res. to Implementation 121, 121 (Kerm Henriksen et al. eds., 2005)Google Scholar (“Leaders of the patient safety movement agree that voluntary reporting systems can measurably improve safety if reporting is protected against discovery and provides reporters with useful information from expert analysis.”).

49 See id. at 130 (discussing the public's demand for transparency).

50 To Err is Human, supra note 1, at 86. See Phillips et al., supra note 39, at 130 (“The IOM recognized the tension between the public's demand for transparency and the health system's insistence on confidentiality and legal protection for reported errors.”).

51 See S. Rep. No., 108-196, at 6 (2003) (“This legislation recognizes that patient safety can best be improved by fostering efforts to identify and fix errors while ensuring that providers remain accountable for malpractice.”).

52 See Regierungsentwurf [Cabinet Draft], Deutscher Bundestag: Drucksachen [BT] 18/10203, at 4-5, http://dip21.bundestag.de/dip21/btd/18/102/1810203.pdf (discussing goals of the PRG, which include strengthening patients' rights and improving patient safety).

53 See Aktionbündnis Patientensicherheit et al., Einrichtung und Erfolgreicher Betrieb Eines Berichts-und Lernsystems (CIRS): Handlungsempfehlung für stationäre Einrichtungen im Gesundheitswesen [Successful Implementation and Operation of a Reporting and Learning System (CIRS): Recommendation for Use in Inpatient Healthcare Institutions] 7 (2016), https://www.patientensicherheit.ch/fileadmin/user_upload/1_Projekte_und_Programme/CIRRNET/180115_HE_CIRS_2016_D_V1.1.pdf [hereinafter APS].

54 Wolf & Hughes, supra note 23, at 2-333.

55 Barnes et al., supra note 31, at 4.

56 See id. at 3.

57 To Err is Human, supra note 1, at 102.

58 See The Essential Role of Leadership in Developing a Safety Culture, The Joint Comm'n, Mar. 1, 2017, at 1, https://www.jointcommission.org/assets/1/18/SEA_57_Safety_Culture_Leadership_0317.pdf (“[A] leader who is committed to prioritizing and making patient safety visible through every day actions is a critical part of creating a true culture of safety.”); APS, supra note 45, at 5 (emphasizing importance of support for error reporting by all levels of management); Wolf & Hughes, supra note 23, at 2-339 (stating leadership commitment is necessary to increase error reporting).

59 To Err is Human, supra note 1, at 5, 49.

60 Id. at 51-55.

61 See id. at 55-57 (discussing latent failures and active errors); Barth, Aus Fehlern Lernen, supra note 47 (discussing the application of Reason's human error research to the healthcare industry); James Reason, Human Error: Models and Management, 320 BMJ 768, 769 (2000) (discussing the “Swiss Cheese Model” of system accidents).

62 See Reason, supra note 53, at 768.

63 See id. at 769.

64 Id.

65 Id.

66 To Err is Human, supra note 1, at 89-90 (recommending the establishment of voluntary reporting systems to improve patient safety); WHO Draft Guidelines, supra note 10, at 58 (recommending error reporting systems to improve safety).

67 Beschlussprotokoll des 108. Deutschen Ärztetages [Resolution of the 108^TH German Medical Assembly] 34-37 (2005) (on file with the Bundesaerztekammer in Berlin), https://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/Beschluesse108.pdf.

68 Günter Jonitz, President, Berlin Chamber of Physicians, Medical Success Leads to Medical Error: How Health Professionals Accept Responsibility for Safety, Plenary Session at the International Forum on Quality and Safety in Health Care (March 19, 2009) (on file with the Bundesaerztekammer in Berlin).

69 See id. (discussing establishment of APS); see also CIRSmedical.de, ÄZQ (Aug. 29 2018), https://www.aezq.de/patientensicherheit/cirs [https://perma.cc/9NM4-79Z9] (describing CIRS reporting system).

70 Netzwerk CIRSmedical, supra note 13.

71 See Gesetz zur Verbesserung der Rechte von Patientinnen und Patienten [Patients' Rights Law], Feb. 25, 2013, BGBl I at 277.

72 Sozialgesetzbuch V Gesetzliche Krankenversicherung [SGB V] [Social Health Insurance Code] § 135a.

73 SGB V § 135a, ¶ 3.

74 SGB V § 137.

75 Fiona McDermott & Tanja Manser, Institut für Patientensicherheit, Deutschlandweite Befragung zum Einführungsstand des klinischen Risikomanagements [Germany-Wide Survey on the Implementation Status of Clinical Risk Management] 6 (2015), https://www.ifpsbonn.de/projekte/prasentation-pk-17.09.2015.pdf (citing Jörg Lauterberg, Institut für Patientensicherheit, ABSCHLUSSBERICHT: Befragung zum Einführungsstand von klinischem Risiko-Management (kRM) in deutschen Krankenhäusern [FINAL REPORT: Survey on the Implementation Status of Clinical Risk Management in German Hospitals] (2012), https://www.ifpsbonn.de/projekte/projekte/abschlussbericht-befragung-krm-2010.pdf and Fiona McDermott et al., Institut für Patientensicherheit, Deutschlandweite Befragung zum Einführungsstand des klinischen Risikomanagements [Germany-Wide Survey on the Implementation Status of Clinical Risk Management] (2016), http://www.aps-ev.de/wp-content/uploads/2016/08/ifps-beitrag-3.pdf.

76 See SGB V §§ 135a (discussing quality management systems), 136b (discussing annual quality reports).

77 See SGB V § 136a, ¶ 3.

78 See Press Release, Gemeinsamer Bundesausschus, Risikomanagement- und Fehlermeldesysteme zur Verbesserung der Patientensicherheit in Klinik und Praxis [Risk Management and Error Reporting Systems to Improve Patient Safety in Hospitals and Practices] (Jan. 23, 2014), http://www.g-ba.de/downloads/34-215-516/02-2014-01-23_Risiko-Fehlermanagement.pdf.

79 See Press Release, Gemeinsamer Bundesausschus, Anforderungen an Einrichtungsübergreifende Fehlermeldesysteme von Krankenhäusern als Grundlage für Vergütungszuschläge in Kraft getreten [Requirements for Cross-Facility Error Reporting Systems of Hospitals as a Basis for Remuneration Surcharges] (July 5, 2016), http://www.g-ba.de/downloads/34-215-628/26-2016-07-05_Erstfassung%20Fehlermeldesystem.pdf.

80 See APS, supra note 45, at 5.

81 See id. at 13.

82 SGB V §135a, ¶ 3 (providing that data from error reporting systems cannot be used against the reporter in legal proceedings, except under exceptional circumstances when needed to prosecute a criminal offense of maximum five years imprisonment).

83 See Regierungsentwurf [Cabinet Draft], Deutscher Bundestag: Drucksachen [BT] 18/10203, at 4-5, http://dip21.bundestag.de/dip21/btd/18/102/1810203.pdf (discussing legal protections for whistleblowers).

84 See id. (arguing that the use of CIRS reports in litigation could harm the trust in the system rendering it useless).

85 Cf. Andrea Pauli, Risikomanagement und CIRS als Gegenstand der Krankenhaushaftung [Risk Management and CIRS as Subject of Hospital Liability] 279-81 (2013) (opining that a patient has no right of access to the documentation or data from clinical risk management and hospital-internal CIRS systems). But cf. Thüß, supra note 76, at 154 (arguing that the circumstances under which CIRS reports can be used in civil litigation are unclear).

86 Pauli, supra note 78, at 209-10 (opining that while anonymisation and outsourcing of error reports can reduce the probability that a patient will have access to CIRS reports, access cannot be legally prevented); Thüß, supra note 76, at 154 (arguing that the circumstances under which CIRS reports can be requested in medical malpractice litigation still have to be decided by the courts).

87 Bürgerliches Gesetzbuch [BGB] [Civil Code], § 630g, translation at http://www.gesetze-im-internet.de/englisch_bgb/englisch_bgb.pdf.

88 Thüß, supra note 76, at 116.

89 See Pauli, supra note 78, at 279-81; Thüß, supra note 76, at 116-20.

90 Pauli, supra note 78, at 280.

91 Compare Zivilprozessordnung [ZPO] [Code of Civil Procedure], § 422, translation at https://www.gesetze-im-internet.de/englisch_zpo/englisch_zpo.html [https://perma.cc/5RGU-6B7T] (indicating that German litigants must only produce documents when requested), with Fed. R. Civ. P. 26 (granting American litigations the right to broad discovery).

92 ZPO, § 424, translation at https://www.gesetze-im-internet.de/englisch_zpo/englisch_zpo.html [https://perma.cc/5RGU-6B7T].

93 Martin, G. Arthur, The Privilege Against Self-Incrimination Under Foreign Law, 51 J. Crim. L. & Criminology 161, 172 (1961).Google Scholar

94 See generally Mark Stauch, The Law of Medical Negl. in England and Germany: A Com. Analysis 5 (2008) (explaining that criminal prosecutions for medical negligence are more frequent in Germany, because German criminal law recognizes a crime of negligent bodily injury).

95 Id.

96 Id.

97 Id.

98 Id.

99 See id.

100 See Liang, supra note 28, at 337.

101 See Comparison Of US Programs – Overview - Part VII., SUMMARY States Patient Safety Reporting Options, Quality & Patient Safety, http://www.qups.org/med_errors.php?c=internal&id=199#title [https://perma.cc/CV9Q-2GDX].

102 See Comparison Of US Programs – Overview - Part III. ADVERSE EVENTS / Physician Reporting By States, Quality & Patient Safety, http://www.qups.org/med_errors.php?c=internal&id=195#title [https://perma.cc/83F3-S363].

103 42 U.S.C. §§ 299b-21-b-26 (2012); see S. Rep. No., 108-196, at 3 (discussing the intent of the Act).

104 See 42 U.S.C. §§ 299b-21-26 (2012).

105 See Submit a Case to WebM&M, Patient Safety Network, https://psnet.ahrq.gov/webmm/submit-case [https://perma.cc/K662-AGA4].

106 Id.

107 See id.

108 See The Joint Comm'n, Patient Safety Systems (PS), in Comprehensive Accreditation Manual for Hospitals: The Official Handbook (2017), https://www.jointcommission.org/assets/1/18/CAMH_04a_PS.pdf.

109 Kearney, Kerry A. & McCord, Edward L., Hospital Management Faces New Liabilities, 6 Health Law. 1, 3 (1992).Google Scholar

110 The Joint Comm'n, supra note 102, at Standard LD.04.04.05.

111 Id. at Standard LD.03.01.01.

112 Id. at Standard LD.04.04.05.

113 Id. at Standards LD.01.01.01 & LD.03.02.01.

114 Sentinel Event Policy and Procedures, The Joint Comm'n (June 29, 2017), https://www.jointcommission.org/sentinel_event_policy_and_procedures/ [https://perma.cc/VX38-8YH5].

115 Liang, supra note 28, at 342. These conflicting policy agendas raise legitimate concerns. If healthcare providers are immersed in an adversarial rather than cooperative care environment with their patients, the growing culture of blame and practice of defensive medicine will continue to impede patient safety. On the other hand, if patients are stripped of their basic right to information and access to court as a method of resolving medical negligence claims, the very fabric of a democratic justice system is threatened.

116 See generally Fed. R. Civ. P. 26(b)(1) (generally allowing the discovery of any matter relevant to the claims or defences). Federal Rules Civil of Procedure allow litigants to request documents and electronic information by specifying the “category of the items to be inspected.” Fed. R. Civ. P. 34(b)(1)(A). Although most medical malpractice cases are litigation in state courts, the majority of states have adopted or closely model their civil procedure rules after the federal rules. See generally State Rules of Civil Procedure, USLegal, https://civilprocedure.uslegal.com/rules-of-civil-procedure/state-rules-of-civil-procedure/ [https://perma.cc/C4VG-8KHN] (collecting state rules of civil procedure).

117 See Dollar, Cynthia J., Promoting Better Healthcare: Policy Arguments for Concurrent Quality Assurance and Attorney-Client Hospital Incident Report Privileges, 3 Health Matrix 259, 267-71 (1993).Google ScholarPubMed

118 42 U.S.C. §§ 299b-22 (regarding privilege and confidentiality protection), 299b-21(7)(A) & 299b-21(7)(B)(ii) (2012) (defining PSWP).

119 42 C.F.R. § 3.20 (2017).

120 See, e.g., Charles v. S. Baptist Hosp. of Florida, Inc., 209 So.3d 1199 (Fla. 2017); Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759 (Ky. 2016); Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014).

121 See cases cited supra note 114.

122 See generally Bunnell, 448 S.W.3d 796.

123 Id. at 798-99.

124 Id. at 803-04, 809.

125 Id. at 809.

126 Id. at 814-15 (Abramson, J., dissenting).

127 See generally Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Work Product and Providers' External Obligations, 81 Fed. Reg. 32,655 (May 24, 2016) (codified at 42 C.F.R. pt. 3) (setting forth guidance for patient safety organizations related to the PSQIA).

128 Id.

129 See generally Clouse, 497 S.W.3d 759 (2016).

130 See id. at 761.

131 Id.

132 See Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Work Product and Providers' External Obligations, 81 Fed. Reg. at 32,657-58 (2016).

133 Fla. Stat. §§ 395.0197 (1)(e) (2007) (mandating development of “an incident reporting system based upon the affirmative duty of all health care providers and all agents and employees of the licensed health care facility to report adverse incidents to the risk manager” (emphasis added)), 395.0197(7) (2007) (requiring adverse event reporting to a state agency).

134 Id. at §§ 395.0197(5)(a), (7) (defining adverse incidents for reporting to the agency).

135 Fla. Const. art. X, §§ 25(a) (1968) (giving patients the right to access any records relating to any adverse incident), 25(c)(3) (1968) (defining “adverse medical incident”).

136 Charles v. S. Baptist Hosp. of Florida, Inc., 209 So.3d 1199 (Fla. 2017).

137 Id. at 1211. Specifically, the plaintiff requested the following in discovery: documents, “1) related to adverse medical incidents in Southern Baptist's history, and 2) either related to any physician who worked for Southern Baptist or arising from care and treatment rendered by Southern Baptist during the three-year period preceding Marie Charles' care and treatment through the time when the discovery request was filed.”

138 CIRSmedical.de, supra note 61.

139 See discussion supra Part IV.B.

140 See discussion supra Part IV.A

141 See id.

142 See Barnes et al., supra note 31, at 4 (explaining that adverse events may not be caused by a medical error); Boothman, supra note 31; Souter & Gallagher, supra note 26.

143 See Barnes et al, supra note 31; Boothman, supra note 31.

144 Barnes et al., supra note 31, at 7.

145 Id.

146 See id.; Schwappach, David L. B., Nach dem Behandlungsfehler: Umgang mit Patienten, Angehörigen und dem Involvierten Personal [After the Treatment Error: Dealing with Patients, Relatives and the Staff Involved] 58 Bundesgesundheitsbl 80, 82 (2015)CrossRefGoogle Scholar.

147 See Souter & Gallagher, supra note 26, at 616.

148 See Gallagher, Thomas H. et al., Collaboration with Regulators to Support Quality and Accountability Following Medical Errors: The Communication and Resolution Program Certification Pilot, 51:6 Health Servs. Res. 2569, 2570-71 (2016)Google ScholarPubMed.

149 See Gallagher, Thomas H. et al., Disclosing Unanticipated Outcomes to Patients: The Art and Practice, 3 J. Patient Safety 158, 158 (2007)Google Scholar; Souter & Gallagher, supra note 26, at 617.

150 See Katzenmeier, Christian, Patientenautonomie und Patientenrechte [Patients' Autonomy and Patients' Rights], 55 Bundesgesundheitsbl-Gesundheitsforsch-Gesundheitsschutz 1093, 1095 (2012)CrossRefGoogle Scholar; Souter & Gallagher, supra note 26, at 617

151 See Schwappach, supra note 140, at 80; Souter & Gallagher, supra note 26, at 616.

152 Disclosure of Errors, Patient Safety Network (Aug. 2018), https://psnet.ahrq.gov/primers/primer/2/disclosure-of-errors [https://perma.cc/A84T-3KZJ].

153 See Souter & Gallagher, supra note 26, at 616

154 White, Andrew A. et al., The Attitudes and Experiences of Trainees Regarding Disclosing Medical Errors to Patients, 83 Acad. Med. 250, 252 (2008).CrossRefGoogle ScholarPubMed

155 Id.

156 Kaldjian, Lauris C. et al., Disclosing Medical Errors to Patients: Attitudes and Practices of Physicians and Trainees, 22 J. Gen. Internal Med. 988, 988 (2007).CrossRefGoogle ScholarPubMed

157 Id.

158 See Wu, Albert W. et al., Disclosure of Adverse Events in the United States and Canada: An Update, and a Proposed Framework for Improvement, 2 J. of Pub. Health Research 186, 188 (discussing study by Varjavand et al. originally published in 46 Med. Educ. 1149 (2012)).Google Scholar

159 See id.

160 See id.

161 See McLennan, Stuart et al., Regulating Open Disclosure: A German Perspective, 24 Int'l J. for Quality in Health Care 23, 24 (2012)Google ScholarPubMed (“there is currently [in 2011] no empirical data relating to patients' or practitioners' attitudes and views regarding open disclosure, and very little is known about current practice [in Germany].”).

162 Kiesewetter, Isabel et al., Undergraduate Medical Students' Behavioural Intentions Towards Medical Errors and How to Handle Them: A Qualitative Vignette Study, 8 Boston Med. J. Open 1, 6 (2018).Google ScholarPubMed

163 Id.

164 Id.

165 Id.

166 Id.

167 See generally Shelly Reese, Medscape Ethics Report 2016: Money, Romance, and Patients, Medscape (2016) https://www.medscape.com/features/slideshow/ethics2016-part1#page=1 [https://perma.cc/U3C7-E7CW] (reporting results of U.S. survey); Claudia Gottschling & Jürgen F. Schell, The Medscape Ethics Report 2017: A Survey on the Delicate Issues of Medicine, Medscape, (2017), https://deutsch.medscape.com/features/diashow/49000598 [https://perma.cc/4AQJ-X68D] (reporting results of German survey and providing U.S. comparison).

168 See Reese, supra note 185 (While 20% more U.S. physicians than German physicians reported that nondisclosure is not acceptable, the U.S. report notes that the percentage of U.S. physicians that found non-disclosure of harm-causing errors unacceptable fell from 95% in 2010 to 78% in 2016, a result that was “surprising and disturbing” in light of the strong movement promoting apologies on the administrative side).

169 Id.

170 See id. at 617; Disclosure of Errors, supra note 146.

171 See, e.g., To Err is Human, supra note 1, at 157; Mor, Sagit & Einy, Orna Rabinovich, Quality of Health Care and the Role of Relationships: Bridging the Medico-Legal Divide, 22 Health Matrix 123, 131 (2012).Google ScholarPubMed

172 See Souter & Gallagher, supra note 26, at 618.

173 See id.

174 Lambert, Bruce L. et al., The “Seven Pillars” Response to Patient Safety Incidents: Effects on Medical Liability Processes and Outcomes, 51:6 Health Servs. Res. 2491, 2511 (2016).Google ScholarPubMed

175 See Liebermiester, Hermann, How to Avoid Liability Litigation in Courts – Suggestions from a German Example, 8 German Med. Sci. 3 (2010)Google Scholar; Souter & Gallagher, supra note 26, at 618.

176 See Mazor, Kathleen M. et al., Disclosure of Medical Errors: What Factors Influence How Patients Respond?, 21 J. Gen. Intern. Med. 704, 707 (2006)CrossRefGoogle ScholarPubMed; Schwappach, supra note 140, at 80.

177 See Mazor, supra note 154, at 707; Schwappach, supra note 140, at 80.

178 See Burkle, Christopher, Medical Malpractice: Can We Rescue a Decaying System? 86 Mayo Clinic Proc. 326 (2011).CrossRefGoogle ScholarPubMed

179 Disclosure of Errors, supra note 146.

180 Liang, supra note 28, at 358 (citing Schwartz, Joanna C., A Dose of Reality for Medical Malpractice Reform, 88 N.Y.U. L. Rev. 1224, 1239-43 (2013)).Google Scholar

181 See id. at 360.

182 Disclosure of Errors, supra note 146.

183 Code of Medical Ethics Opinion 2.1.3, Withholding Information from Patients (Am. Med. Ass'n 2016), https://perma.cc/6UG8-7GLK.

184 See Geri Amori, Prologue, in ASHRM, Re-Release of the Three ASHRM Disclosure Monographs: Disclosure of Unanticipated Events in 2013 (2013), http://www.ashrm.org/pubs/files/white_papers/Disclosure-of-Unanticipated-Events-in-2013_Prologue.pdf. (discussing the initial release of ASHRM's Monograph on Disclosure in 2001 and a series of three Monographs on Disclosure in 2003).

185 See Barnes et al., supra note 31 (discussing error disclosure policy at Harvard Hospitals); Helmchen, Lorens A. et al., Changes in Physician Practice Patterns after Implementation of a Communication-and-Resolution Program, 51:6 Health Servs. Res. 2516 (2016)CrossRefGoogle ScholarPubMed (discussing the CRP at University of Illinois); The Michigan Model: Medical Malpractice and Patient Safety at UMHS, Univ. of Mich. Health, https://www.uofmhealth.org/michigan-model-medical-malpractice-and-patient-safety-umhs#summary [https://perma.cc/W83V-YK6P] (discussing the disclosure policy at the University of Michigan);

186 Communication and Optimal Resolution (CANDOR) Toolkit, Agency for Healthcare Res. & Quality (May 2016), https://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/candor/introduction.html [https://perma.cc/43JY-ZYNW].

187 See Mello, Michelle M. et al., Communication-and-Resolution Programs: The Challenges and Lessons Learned From Six Early Adopters, 33:1 Health Aff. 20, 22 (2014).CrossRefGoogle ScholarPubMed

188 See id. at 20.

189 See Jontiz & Barth, supra note 21.

190 See id.

191 See Boothman, supra note 31, at 2489.

192 See Monograph: The Next Step in Better Communication, in ASHRM, Re-Release of the Three ASHRM Disclosure Monographs: Disclosure of Unanticipated Events in 2013, 4 (2013)

193 See id at 10.

194 Mello et al., supra note 165, at 20.

195 See Lambert et al., supra note 152, at 2494.

196 See Souter & Gallagher, supra note 18, at 618.

197 See Liang, supra note 28, at 368-69.

198 Barnes et al., supra note 31, at 9.

199 See Souter & Gallagher, supra note 26, at 618.

200 See id. at 616; Disclosure of Unanticipated Events, supra note 170, at 9.

201 See Amori, supra note 162 (discussing the why an expression of empathy may be misheard as an apology).

202 See Saitta, Nicole & Hodge, Samuel D., Jr, Efficacy of a Physician's Words of Empathy: An Overview of State Apology Laws, 112 J. Am. Osteopathic Ass'n 302 (2012).CrossRefGoogle ScholarPubMed

203 Aktionbündnis Patientensicherheit, Reden ist Gold [Talking is Gold] (2012), https://www.aps-ev.de/wp-content/uploads/2016/08/APS_Reden_ist_Gold_2017.pdf [hereinafter Talking is Gold].

204 Loewenbrück et al., supra note 4, at 323.

205 Talking is Gold, supra note 181, at 3.

206 Bundesärztekammer [BÄK], (Muster-)Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte [Model Code for Physicians in Germany] (2018), http://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/pdf-Ordner/MBO/MBO-AE.pdf; see Stuart McLennan et al., Regulating Open Disclosure: A German Perspective, 24 Int'l J. Quality in Health Care 23, 25-26 (2012).

207 See Schelling, Philip & Warntjen, Maximilian, Die Pflicht des Arztes zur Offenbarung von Behandlungsfehlern [The Physician's Duty to Disclose Treatment Errors], 30 MedR 506, 507 (2012)Google Scholar; see also McLennan et al., supra note 203, at 25 (mentioning the impact of the contractual nature of healthcare in Germany).

208 See Talking is Gold, supra note 181, at 6-7; see also Liebermiester, supra note 153, at 3.

209 See ÄrzteZeintung, , Ärzte, die Fehler zugeben, haben Patienten häufig auf ihrer Seite [Doctors Who Admit Mistakes Often Have Patients on their Side], 160 Ärzte Zeitung 13 (2003).Google Scholar

210 Email from Hermann Liebermeister, German physician and retired member of the Saarland medical arbitration body, (Aug. 21, 2018, 7:49 GMT) (on file with the author); See Interview with Hermann Liebermeister, German physician and retired member of the Saarland medical arbitration body, in Frankfurt, Germany (Mar. 7, 2017) (discussing the role of German arbitration bodies and medical errors in Germany).

211 McLennan, supra note 203, at 25.

212 Id.

213 Id. at 215, at 24.

214 Bürgerliches Gesetzbuch [BGB] [Civil Code] § 630c, https://www.gesetze-im-internet.de/bgb/__630c.html [https://perma.cc/4SQF-LY78].

215 Id.

216 See Heberer, Jörg, Das Patientenrechtegesetz [The Patients' Rights Act], 9 Gastroenterologist 278, 279 (2014).Google Scholar

217 Parzeller, Markus et al., Pflicht zur Offenbarung von Behandlungsfehlern nach dem Patientenrechtegesetz [Obligation to Disclose Treatment Errors According to the Patient Rights Act], 24 Rechtsmedizin 263, 264 (2014).CrossRefGoogle Scholar

218 Id. at 265.

219 See Stefan Loos et al., IGES Institut, Studie zu den Wirkungen des Patientenrechtegesetzes [Study on the Effects of the Patients' Rights Act] 51-54 (2016), http://www.patientenbeauftragter.de/images/veranstaltungen/2016/patientenrechtegesetz/20161109_IGES-Studie_Wirkungen_Patientenrechtegesetz.pdf.

220 See id.

221 See id.

222 See id.; Schelling & Warntjen, supra note 185.

223 See Loos et al., supra note 194; Parzeller et al., supra note 160, at 269 (“The Federal Constitutional Court states: ‘The individual should not in principle, be brought into a situation of conflict by the state in which he must accuse himself of criminal acts or similar misconduct or is tempted to commit a new offence by making false statements, or if his silence is in danger of being subjected to coercive means.’”).

224 See Loos et al., supra note 194.

225 See id.; Schelling & Warntjen, supra note 185, at 507-08.

226 See Loos et al., supra note 194, at 51-54; Parzeller et al., supra note 192, at 266; Schelling & Warntjen, supra note 185, at 507-09.

227 See Parzeller et al., supra note 192.

228 See Loos et al., supra note 162, at 51-54.

229 See Brechenkamp, Juergen et al., Progress on Quality Management in the German Health System – A Long and Winding Road, 5 Health Res. Pol'y & Sys. 1, 7 (2007),CrossRefGoogle Scholar

230 See id.

231 ÄrzteZeintung, supra note 187.