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Compliance

Compliance, medico-legal considerations and enforceable obligations

Credit: Weiss Paarz Medical Malpractice Attorneys

Unmanaged post-viral disease liability, risk exposure and rising pandemic exposure (draft)

Compliance obligations for professionals, operational and expertise risks in practice management, social care, occupational health intermediation, insurance underwriting, claims management and reinsurance

These compliance documents are live pre-released drafts that are specifically not structured for scientific audiences. Specific scientific referencing can be provided in consulting contexts, not limited to practice management, claims management, underwriting or litigation support for professionals or organisations.

Copyright and redistribution rights are governed by our terms of site usage. Communication of factual or typographical errata or other suggestions is welcome. This content was originally contained here (external link), has been split into separate compliance sections on our website and is in need of significant ongoing update.

NICE ME/CFS Guideline 2021

A journalistic summary of these documents for lay audiences will soon be published.

Summary

The role of habitualised unlawful clinical judgement and discrimination that leads to elevated probability of evidentiable malpractice is outlined. Obligations and principles are detailed below and offer opportunities for risk mitigation in response. Currently underestimated risks from appropriate use of discrimination law or freedom of information law are highlighted.

“The empirical improbability that a clinician’s judgement can be assumed safe, appropriate or lawful in this field is demonstrated, alongside multiple examples of habitual breaches, risk generation and tests of legality“

Doctors with M.E.

Post-viral disease is an undermined field of risk assessment, pricing, budgeting, compliance management, reputation management and liability generation. Elevated probability of unlawful clinical judgement and/or administrative decision-making in this field pervades clinical and therapeutic services and related contracting parties. Risks are routinely misjudged. These risks are exacerbated by normalised procurement of fallacious services or testimony, all failing to account for the following factors:

  • Clinical judgement, administrative decision-making, guidelines, policy formulation or policy implementation that fails to meet the requirements of the law are not lawful by definition and carry risk
  • Claims that do not meet the thresholds of scientific probity, rigour and/or process cannot be described as science and are thus legally unsustainable and carry risk (regardless even of partial or total contradiction by bodies of work that are sufficiently substantive)
  • Claims that are legally unsustainable do not change their risk-profile when obfuscated by office-holders or purported eminence, which instead introduce additional risks
  • Clinical judgement or administrative decision-making that depends on such claims of normalised failure cannot therefore sustain claims of lawfulness and carry risk
  • Claims of the habitual nature of consequent failings do not form a legally sustainable defence and counter-productively demonstrate institutionalised compliance breaches, discrimination and other unlawful contexts
  • Education or organisational policies regularly encourage zero-return risk, by directly cultivating unlawful behaviour, versus statutory provisions, duties of care, policy and regulation

Medico-legal issues, requirements and enforcement factors are discussed. Legal obligations on service providers versus current risk generation are then outlined, along with their impacts on liability, malpractice-risk and indemnification. Risk-mitigation measures are offered throughout and are followed by compliant education resources.

Pertinent to practice management, insurance claim management and reinsurance underwriting review, examples of frequent and unlawful clinical judgement are utilised (influenza and covid vaccination scheme eligibility and FND diagnosis). These are used to illustrate commonly unaddressed frontline risk generation in the area of post-viral disease and generalisable implications that are portable across contexts, ranging from occupational medicine to social care.

Context of unmanaged liabilities

Audience, scope and disclaimer

Our Compliance pages provide health and social care providers and practitioners, insurance underwriters and reinsurers, claims management firms, intermediary agencies, litigators and related organisations with information regarding unmanaged and growing risks from specific, widely evidenced and normalised medical error and malpractice. Wording is necessarily direct, being focused on organisational risk and liability exposure (notions of intra-medical professional decorum accelerate malpractice-risk, due the suspension of legal and compliance norms that is unlawfully institutionalised).

The reader thus assumes full responsibility for its use or for failure to account for matters raised and their implications for individual and group litigation/class action contexts. Dangers include reputational risk and disproportionately unnecessary risks to balance sheets, both in terms of 1) liabilities accumulated, 2) liabilities accumulated and unaccounted for and 3) liabilities now growing at an accelerated rate due to the pandemic (with the British Medical Association and US National Institutes of Health NAIAD specifically identifying ME/CFS as a likely post-covid neurological syndrome).

“Involuntarily assumption of risk by third party organisations, client industries and employers is also highlighted – liabilities are obfuscated and shifted to them by individuals, government, clinical commissioning groups, regulatory or self regulatory bodies or other organs”

Doctors with M.E.

Examples are given that demonstrate the roles of legal and policy requirements versus normalised unlawful clinical judgement. Tests for clinical judgement lawfulness are also outlined. Principles contained therein are generalisable by third parties to different post-viral and related scenarios that are driven by equivalent factors, for example in those Long Covid cases that meet pre-existing diagnostic criteria.

The empirical improbability that a clinician’s judgement can be assumed safe, appropriate or lawful versus ME/CFS is also shown. This leads to the generalisable obligation to procure compliant education and other legal obligations, derived from multiple statutory risks and regulatory imperatives reflected by the official and self-regulatory bodies (such as the UK General Medical Council (GMC), the Care Quality Commission (CQC) and their equivalents in other jurisdictions).

Involuntarily assumption of risk by third party organisations, client industries and employers is also highlighted – liabilities are obfuscated and shifted to them by individuals, government, clinical commissioning groups, regulatory or self regulatory bodies or other organs (link). Obfuscated redistribution of liabilities to frontline and third party balance sheets is closely related to underestimated limits on the role of governmental, agencies and other bodies, which are all subject to the law (link) and whose avoidance of liabilities can be most easily achieved by ensuring others’ responsibility.

This information provision is without warranty and no guidance should be interpreted herein. This document provides neither legal, medical nor any other form of advice. Formal medico-legal advice should be taken regarding post-viral disease where appropriate.

Risk mitigation

See the above legal obligations for context and the governing implications from 1) the elevented likelihood of unlawful clinical judgement in this field versus 2) medico-legal requirements, ongoing failure and enforcement-risks.

Resources that contribute to compliance with the above obligations can be found in our education resources section (which is currently in construction).

References

Selected references (disordered)
  1. Care Quality Commission – What can you expect from a good GP practice? https://www.cqc.org.uk/help-advice/what-expect-good-care-services/what-can-you-expect-good-gp-practice#Responsive
  2. General Medical Council – The duties of a doctor registered with the General Medical Council https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice/duties-of-a-doctor#:~:text=Listen%20to%2C%20and%20respond%20to,improve%20and%20maintain%20their%20health.
  3. Whitty, Doyle, Powis, “The national flu immunisation programme 2020/21” https://www.england.nhs.uk/wp-content/uploads/2020/05/national-flu-immunisation-programme-2020-2021.pdf, 14th May 2020
  4. NHS UK, “Who should have the flu vaccine?” https://www.nhs.uk/conditions/vaccinations/who-should-have-flu-vaccine/, July 2019
  5. NHS SNOMED CF / SCTID: 52702003 https://termbrowser.nhs.uk/?perspective=full&conceptId1=52702003&edition=uk-edition&release=v20200610
  6. WHO ICD 10 2019 https://icd.who.int/browse10/2019/en#/G93.3
  7. WHO ICD 11 https://icd.who.int/dev11/l-m/en#/http://id.who.int/icd/entity/767044268
  8. Advising appropriateness in the individual case does depend on patient vaccine response history, https://meassociation.org.uk/wp-content/uploads/Flu-Vaccinations-2019-20-September-2019.pdf https://www.actionforme.org.uk/news/should-i-get-a-flu-jab-if-i-have-me/
  9. Report on the impact of Covid-19 on ME – Preliminary findings from a survey on ME and Covid-19 https://www.meaction.net/2021/04/29/covid-19-has-worsened-our-me-report-survey-respondents/ and https://www.actionforme.org.uk/news/survey-results-so-far-impact-of-covid-on-me/
  10. Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Board on the Health of Select Populations, and Institute of Medicine (2015),
  11. Communication from the JCVI regarding ME/CFS & covid vaccination clinical judgement to Dr. Charles Shepherd https://meassociation.org.uk/2021/02/latest-covid-19-me-cfs-and-the-jcvi-priority-vaccination-list/
  12. The Secretary of State for Health and Social Care, Matt Hancock, has commented on this guidance and said that it should also be applied to people with ME/CFS: https://meassociation.org.uk/2021/02/matt-hancock-on-me-cfs-covid-vaccine-priority/
  13. Green Book Chapter 14a – COVID-19 – SARS-CoV-2, pp.9-12, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/961287/Greenbook_chapter_14a_v7_12Feb2021.pdf
  14. House of Lords parliamentary question on COVID-19 vaccine eligibility for people with underlying health conditions https://meassociation.org.uk/2021/04/house-of-lords-parliamentary-question-on-covid-19-vaccine-eligibility-for-people-with-underlying-health-conditions
  15. As per the BMA’s Long Covid Taskforce head’s (Dr. David Strain) references on BBC Horizon regarding ME-type long covid tying into / extended ongoing ME/CFS research into mitochondrial and small blood vessel abnormalities (glycolysis focused ME/CFS research directly relates to these). See 43-49mins on http://www.bbc.co.uk/iplayer/episode/m000slmx or the specific segment on https://youtu.be/rWLqLahjrWI
  16. “Patient evidence to the MEA also indicates that almost everyone with ME/CFS who has caught COVID-19 has had a significant and/or prolonged relapse of ME/CFS. This is not surprising given the considerable degree of clinical overlap between ME/CFS and Long Covid” https://meassociation.org.uk/wp-content/uploads/ME-Association-Covid-Vaccine-Priority-Template-GP-Letter-V3-19.02.21.docx
  17. BBC Points West programme, Thursday 4th March, 1830 https://www.bbc.co.uk/iplayer/episode/m000sw7v/points-west-late-news-04032021 and frequently after surgery reexamination of eligibility based this comprehensive letter from the ME Association https://meassociation.org.uk/wp-content/uploads/ME-Association-Covid-Vaccine-Priority-Template-GP-Letter-V3-19.02.21.docx
  18. ME Association Surveys https://meassociation.org.uk/mea-surveys
  19. Section 3.3.2 of the Chief Medical Officer’s Working Group Report on ME/CFS: https://meassociation.org.uk/wp-content/uploads/CMO-Report-2002.pdf
  20. Section 1.6.4 of the new (draft) NICE clinical guideline on ME/CFS which will become operational in April 2021: https://www.nice.org.uk/guidance/gid-ng10091/documents/draft-guideline5c
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  38. Friedman, Kenneth J., 2019, Advances in ME/CFS: Past, Present, and Future, Frontiers in Pediatrics 7
  39. Geraghty, K, 2020, The BMJ’s “War on Information,”
  40. Geraghty, Keith, Mark Hann, and Stoyan Kurtev, 2017a, Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys:, Journal of Health Psychology.
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  43. Geraghty, Keith J., and Charlotte Blease, 2019, Myalgic encephalomyelitis/chronic fatigue syndrome and the biopsychosocial model: a review of patient harm and distress in the medical encounter, Disability and Rehabilitation 41, 3092–3102.
  44. Hng, Dr KN, 2019, M.E. and Me: A Doctor’s Struggle with Chronic Fatigue Syndrome (Independently published).
  45. Hng, K.N., 2018, Doctors’ Knowledge and Understanding of ME.
  46. Jason, L. A., and J. A. Richman, 2007, How Science Can Stigmatize: The Case of Chronic Fatigue Syndrome, Journal of Chronic Fatigue Syndrome 14, 85–103
  47. Jason, L. A., D. Ohanian, A. Brown, M. Sunnquist, S. McManimen, L. Klebek, P. Fox, and M. Sorenson, 2017, Differentiating Multiple Sclerosis from Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, Insights in Biomedicine 2
  48. Jason, Leonard A., Judith A. Richman, Alfred W. Rademaker, Karen M. Jordan, Audrius V. Plioplys, Renee R. Taylor, William McCready, Cheng-Fang Huang, and Sigita Plioplys, 1999, A Community-Based Study of Chronic Fatigue Syndrome, Archives of Internal Medicine 159, 2129–2137
  49. Jason, Leonard A., Nicole Porter, Jessica Hunnell, Alfred Rademaker, and Judith A. Richman, 2011, CFS prevalence and risk factors over time, Journal of Health Psychology 16, 445–456
  50. Kindlon, T, 2009a, Many questions remain about treatments for CFS, BMJ. Rapid Response.
  51. Kindlon, Tom, 2017, Do graded activity therapies cause harm in chronic fatigue syndrome?, Journal of Health Psychology 22, 1146–1154.
  52. Kindlon, Tom P., 2009b, Small correction in reference to Cohen’s d values in my last message, BMJ. Rapid Response.
  53. Kingdon, Caroline C., Erinna W. Bowman, Hayley Curran, Luis Nacul, and Eliana M. Lacerda, 2018, Functional Status and Well-Being in People with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Compared with People with Multiple Sclerosis and Healthy Controls, PharmacoEconomics – Open 2, 381–392
  54. Komaroff, Anthony L., Laura R. Fagioli, Teresa H. Doolittle, Barbara Gandek, Marcy A. Gleit, Rosanne T. Guerriero, R. James Kornish, Norma C. Ware, John E. Ware, and David W. Bates, 1996, Health status in patients with chronic fatigue syndrome and in general population and disease comparison groups, The American Journal of Medicine 101, 281–290
  55. Lavery, G., and N. Muirhead, 2019, What Should be Taught to Medical Students about Myalgic Encephalomyelitis/Chronic Fatigue Syndrome?, Journal of Invest in ME Research 13. Medical Education, 22.
  56. Mandarano, Alexandra H., Jessica Maya, Ludovic Giloteaux, Daniel L. Peterson, Marco Maynard, C. Gunnar Gottschalk, and Maureen R. Hanson, 2019, Myalgic encephalomyelitis/chronic fatigue syndrome patients exhibit altered T cell metabolism and cytokine associations, The Journal of Clinical Investigation
  57. McKay, P. G., and C. R. Martin, 2010, Quality of Life Issues in Chronic Fatigue Syndrome, in Victor R. Preedy and in Ronald R. Watson ed.: Handbook of Disease Burdens and Quality of Life Measures (Springer, New York, NY)
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  59. Monaghan, C., MP, 2018, PACE Trial: People with ME – Hansard, (Hansard, House of Commons, Palace of Westminster).
  60. Morten Group, University of Oxford, 2020, Science of ME/CFS, Morten Group, University of Oxford
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  65. Nacul, Luis, Shennae O’Boyle, Luigi Palla, Flavio E. Nacul, Kathleen Mudie, Caroline C. Kingdon, Jacqueline M. Cliff, Taane G. Clark, Hazel M. Dockrell, and Eliana M. Lacerda, 2020, How Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Progresses: The Natural History of ME/CFS, Frontiers in Neurology 11
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Version history

Record of major revisions across our Compliance pages.

v0.06
  1. Transpose of richardramyar.com article into separate compliance posts/sections on the Doctors with M.E. website
  2. Minor updates
  3. Language updates pending
v0.05
  1. Executive summary addition
  2. Additional callout quotes added prior to FOIA section
v0.04
  1. Draft caveat and errata invite moved to below contents bullets
  2. Addition of history of vexatious complaints/leverage/contact against scientists by medics and Hansard quote regarding ‘one of the biggest medical scandals of the 21st century’ and restructure into bullets
  3. Addition of Monaghan, Davey, Timms, Newlands Hansard references
  4. Knowledge gap liability audit trail – addition of bracketed idiopathic/unexplained/FND fatigue to false equivalence
  5. Link reference from the legal obligation to detail and communicate to the need to maintain eduction records
  6. Obligation to educate and appropriate record keeping – addition of the firewalling risks to the organisation, documenting refusals of education and questions regarding a practitioner’s mental health and capacity
  7. Obligation to educate and appropriate record keeping – addition of the firewalling risks to the organisation, documenting refusals of education and questions regarding a practitioner’s mental health and capacity
  8. Addition of redefinition of scientific standards to validate verified low standards and claim a fallacious ‘split in the science’ that does not exist – to expertise-risk and education-risk generation sections
  9. Addition to Scope that document wording is necessarily direct due to focus on organisational risk and liability exposure
  10. Further addition of GMC and CQC breaches versus the obligation to maintain detailed records and communcications that are accurage – to education and record keeping obligations
  11. Readdition of educational resources in advertently dropped
v0.03
  1. Addition of version history section
  2. Addition of Kindlon references regarding harms, etc.
  3. Addition of Tack and Van Den Brink Dark History of Somatic Medicine series (Multiple Sclerosis, Asthma, Diabetes)
  4. Link to knowledge gap illustration vs liability audit trail and fallacious belief systems table in Expertise-Risk section
  5. Expertise-risk update, including link to knowledge gap illustration/table vs liability audit trail and fallacious belief systems table in Expertise-Risk section
  6. Reference to medical-encounter PTSD versus obligation to educate, diagnostic audit trail, knowledge gap illustration/table