An  Ontology  for  Medical  Treatment  Consent

Bo  Yu,  Duminda  Wijesekera  and  Paulo  Costa    Department  of  Computer  Science  

George  Mason  University,  Fairfax  VA,  USA  

{byu3,  dwijesek,  pcosta}@gmu.edu

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SEMANTIC  TECHNOLOGY  FOR  INTELLIGENCE,  DEFENSE,  AND  SECURITY  ─  STIDS 2014

Introduction●Medical  treatments  require  informed  treatment  consents  ● Informed  medical  treatment  consents  have  great  benefits,    

• “a  properly  completed  consent  form  would  have  prevented  45%  of  errors”  on  surgery  wrong  sites  [25-­‐26]  

However  

   

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Introduction  (Cont.)● Failure  to  obtain  informed  treatment  consent  may  cause  errors,  mal-­‐practice  

   

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After  Cohen,  the  clin

ic's  medical  

director,  finished  his

 work,  a  biopsy  

was  done  on  Rivers  w

ithout  her  prior  

consent,  according  t

o  the  source.

➢  Joan  Rivers  (Sept.  4th,  2014)  http://www.cnn.com/2014/10/16/showbiz/joan-­‐rivers-­‐cause-­‐of-­‐death/index.html

Investigators  have  found  no  prior  consent  form  signed  by  Rivers  authorizing  a  procedure  by  her  doctor.  It  was  unclear  if  Rivers  had  given  verbal  consent  to  the  doctor  or  not.

The  General  Problem●Most  medical  facilities  use  Electronic  Medical  Record  systems  (EMRs)  for  treatment  and  care  

● It  is  desirable  to  obtain,  verify  and  act  according  to  the  legally  enforced  medical  treatment  consent  using  EMRs

●EMRs  do  not:  Obtain  and  enforce  informed  treatment  consents  

● Informed  medical  treatment  consents  are:  complex

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Complexity  of  Informed  Consent

● Informed  Patient  Consent  is  required  for  medical  procedures  

● Informed  medical  treatment  consents  are  governed  by    ● individual  state  laws,    ● institutional  policies,    ● is  unique  to  the  procedure  to  be  performed  

and  the  patient’s  circumstances

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Benefits  of  Improving  Electronic  Patient  Informed  Consent  Management  

● Beneficial  to  general  patients  and  care  givers  

● Beneficial  to  patients  who  relocate  frequently,  such  as  active  duty  military  and  their  families  

● Beneficial  to  centralized  Military  Health  Services  which  have  applicable  local  consent  regulations  built  in  as  a  service

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Related  Works● Consents  for  sharing  medical  data  [10]  [16-­‐18]  ● Consents  for  research  permission  ● Veterans  Administration  Medical  Centers  use  

iMedConsent™  [2]  that  supports  electronic  access,  completion,  signing,  and  storage  of  informed  consent  forms  and  advance  directives  ● But  the  consent  forms  are  pre-­‐canned

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Our  Solution● Automate  the  evaluation  and  enforcement  

of  informed  treatment  consents  within  treatment  plans  (refers  to  as  medical  workflows)  at  run-­‐time  by  using  existing  EMRs  

● We  auto-­‐generate  consent  forms  from  rules

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Architecture  of  Proposed  EMRs:-­‐  High  level  view  -­‐  

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middleware

Invisible to the EMR systems’ users

New  EMR  System?  

Enforcement  Consent  System

Challenges  of  our  Approach✓ Need  flexibility  in  enforcing  state  laws  and  

institutional  policies  that  govern  medical  treatment  consent  

✓ Need  to  dynamically  alter  a  workflow-­‐based  EMR  orchestration  based  on  specific  patient’s  info/state  consent  laws/treatment  type  

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Components  of  Consents● Rule  (1)  Information  or  Disclosure:  disclose  the  treatment  information    

● Rule  (2)  Decisional  Capability:  Evaluation  of  patients  competency  in  understanding  of  the  information  …have  ability  to  provide  a  rational  and  voluntary  decisions  about  the  treatment  

● Rule  (3)  Competency:  Validation  of  patient’s  maturity  to  grant  informed  consent

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StateState

Abbreviation Pregnancy

1. Any minor (Ala. Code § 22-8-6);

1. An unemancipated minor (Cal. Fam. Code § 6925);

1. No explicit lawWYOMING WY

18 years of age or older (Wyo. Stat. Ann. § 14

!1

!101(a))

1. Minor is or was legally married – minor is married, widow (Wyo. Stat. Ann. § 14-1-101(b)); 2. Minor is or was legally married – minor is divorced (Wyo. Stat. Ann. § 14-1-101(b));3. Minor who is in active military service of the United States may consent for healthcare treatment (Wyo. Stat. Ann. § 14-1-101(b)); 4. Minor who is living apart from his parents or guardian and managing his/her own affairs may consent for healthcare treatment(Wyo. Stat. Ann. § 14-1-101(b)); 5. Minor is an emancipated minor (Wyo. Stat. Ann. § 14-1-101(b));

CALIFORNIA CA

18 years of age or older (Cal. Fam. Code § 6500)

1. Minor is an emancipation minor (Cal. Fam. Code § 7050);2. Minor is 15 years of age or older, who is living separate and apart from the minor's parents or guardian and managing the minor's own financial affairs (Cal. Fam. Code § 6922); 3. Married Minor is an emancipation minor (Cal. Fam. Code § 7002);4. Minor is 16 years of age or older, who serves in the armed forces of the United States or has court order is an emanicpated minor (CAL. FAM. CODE § 6950 (2012));

● ● ● ● ● ●

● ● ● ● ● ●

General Medical Treatment

ALABAMA AL

19 years of age or older (Ala. Code § 26

!1

!1)

1. Minor age equal or greater than 18, less than 19, and minor has an emancipation order (Ala. Code §§ 26-13-1 and 26-13-5);2. Minor age 14 or old, has graduated from high school (Ala. Code § 22-8-4); 3. Minor is married (Ala. Code § 22-8-4; Ala. Code § 22-8-5); 4. Minor having been married and divorced (Ala. Code § 22-8-4; Ala. Code § 22-8-5);5. Minor is pregnant (Ala. Code § 22-8-4); 6. Minor has child(ren) (Ala. Code § 22-8-5);

Specification  of  Treatment  Consents

Specification  of  Treatment  Consents● Example  of  rules:  

  Cal.  Fam.  Code  §  7050  states  that  an  emancipated  minor  may  consent  for  medical,  dental,  or  psychiatric  care,  without  parental  consent,  knowledge,  or  liability.  

●Need  standardizable  semantics  ➢Different  disciplines  using  different  terms  to  represent  the  same  thing  

➢the  knowledge  keeps  growing,  the  relationships  become  more  complex

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● Systematized  Nomenclature  of  Medicine-­‐-­‐Clinical  Terms  (SNOMED  CT)  ➢   The  most  comprehensive,  multilingual  clinical    healthcare  terminology    

➢      SNOMED  CT  and  medical  Ontologies  

 But  treatment  consent  is  missing

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Specification  of  Treatment  Consents

Consent  Components

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StateState

Abbreviation Pregnancy

1. Any minor (Ala. Code § 22-8-6);

1. An unemancipated minor (Cal. Fam. Code § 6925);

1. No explicit lawWYOMING WY

18 years of age or older (Wyo. Stat. Ann. § 14

!1

!101(a))

1. Minor is or was legally married – minor is married, widow (Wyo. Stat. Ann. § 14-1-101(b)); 2. Minor is or was legally married – minor is divorced (Wyo. Stat. Ann. § 14-1-101(b));3. Minor who is in active military service of the United States may consent for healthcare treatment (Wyo. Stat. Ann. § 14-1-101(b)); 4. Minor who is living apart from his parents or guardian and managing his/her own affairs may consent for healthcare treatment(Wyo. Stat. Ann. § 14-1-101(b)); 5. Minor is an emancipated minor (Wyo. Stat. Ann. § 14-1-101(b));

CALIFORNIA CA

18 years of age or older (Cal. Fam. Code § 6500)

1. Minor is an emancipation minor (Cal. Fam. Code § 7050);2. Minor is 15 years of age or older, who is living separate and apart from the minor's parents or guardian and managing the minor's own financial affairs (Cal. Fam. Code § 6922); 3. Married Minor is an emancipation minor (Cal. Fam. Code § 7002);4. Minor is 16 years of age or older, who serves in the armed forces of the United States or has court order is an emanicpated minor (CAL. FAM. CODE § 6950 (2012));

● ● ● ● ● ●

● ● ● ● ● ●

General Medical Treatment

ALABAMA AL

19 years of age or older (Ala. Code § 26

!1

!1)

1. Minor age equal or greater than 18, less than 19, and minor has an emancipation order (Ala. Code §§ 26-13-1 and 26-13-5);2. Minor age 14 or old, has graduated from high school (Ala. Code § 22-8-4); 3. Minor is married (Ala. Code § 22-8-4; Ala. Code § 22-8-5); 4. Minor having been married and divorced (Ala. Code § 22-8-4; Ala. Code § 22-8-5);5. Minor is pregnant (Ala. Code § 22-8-4); 6. Minor has child(ren) (Ala. Code § 22-8-5);

Methodology●Enforcement  Mechanism    ▪ Consent  act  as  an  attribute  X  to  control  the  progression  of  the  flow  ▪ Design  an  evaluation  mechanism  as    X=  f(x1,  x2,..,xn)  ▪ f  is  computed  from  a  rule  base

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Minor  Consent,  Confidentiality,  and  Child  Abuse  Reporting  in  CaliforniaA  minor  may  consent  for  his  or  her  medical  or  dental  care  if  he  or  she  meets  the  following  three  requirements:

                   

                           Rules:

   1.  The  minor  is  15  years  of  age  or  older;      2.  The  minor  is  living  separate  and  apart  

from  her  parents  or  guardian,  whether  with  or  without  the  consent  of  a  parent  or  guardian,  and  regardless  of  the  duration  of  this  separation;  and  

     3.The  minor  is  managing  the  minor’s  own  financial  affairs,  regardless  of  the  source  of  the  minor’s  income.

Cal.Family  Code  §  6922(a).  

Rule  Create  from  Minor  Consent  State  Law

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State predication Meaning Related State LawALABAMA - AL  

patientRequiresTreatment(p, tn) ∧ (tn = “generalTreatment”) ∧ hasTreatmentName(t, tn) ∧ patientTreatmentPerformedIn(p, sn) ∧ (sn = “AL”) ∧ hasStateName(s, sn) ∧ performedIn(t, s) ∧ patientHasEmancipationOrder(p, heo) ∧  (heo  =  True)  ∧  hasAge(p, age) ) ∧ (19 > age ≥ 18) → AdultPatient(p)

If 18 years of age or older and less than 19 years old, patient p has treatment t with treatment name tn is “generalTreatment” performed in state s with state name sn is “AL”, treatment t is allowed performing in state s, and patient has an emancipation order, this patient p is adult patient. Where t is treatment with name tn of patient required; s is state with state name sn where patient performs treatment t; heo is status of holding an emancipation order of patient p; age is age of patient p

1. Minor age equal or greater than 18, less than 19, and minor has an emancipation order (Ala. Code §§ 26-13-1 and 26-13-5);

……patientRequiresTreatment(p, tn) ∧ (tn = “generalTreatment”) ∧ hasTreatmentName(t, tn) ∧ patientTreatmentPerformedIn(p, sn) ∧ (sn = “AL”) ∧ hasStateName(s, sn) ∧ performedIn(t, s) ∧ patientHasEmancipationOrder(p, heo) ∧  (heo  =  False)  ∧  patientGraduatedFromHighschool(p, gfhs)  ∧ (gfhs  =  False)  ∧  patientMarried(p, m)  ∧ (m  =  False)  ∧    patientDivorced(p, d)  ∧ (d  =  False)  ∧  patientIsPregnant(p, ip)  ∧ (p  =  False)  ∧  patientHasChild(p, hc)  ∧ (hc  =  False)  ∧  hasAge(p, age) ∧ (18≤ age <19)  ∧ performedIn(t, s) → MinorPatient(p)

If 18 years of age or older and less than 19 years old, patient p has treatment t with treatment name tn is “generalTreatment” performed in state s with state name sn is “AL”, treatment t is allowed performing in state AL, and patient does not have an emancipation order, child, does not graduate from high school, and is not married, divorced, pregnant, this patient p is minor patient. Where t is treatment with name tn of patient required; s is state with state name sn where patient performs treatment t; gfhs is status of graduation from high school of patient p; m, d is marital status of patient p; ip is pregnancy status of patient p; hc is parental status of patient p; age is age of patient p

Concepts  in  Medical  Consent  Domain

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Classes Meaning

Patient

A person who is seeking medical assistance. Each patient also associates with a set of attributes which we created based on the patient basic information, like age, name, etc. and patient active statuses which should be used to evaluate the patient maturity.

TreatmentThe methods which the patients seek to combat, ameliorate, or prevent a disease, disorder, or injury. Each treatment has treatment name, such as eye surgery, dialysis, and so on.

Procedures Generally, every treatment consisted of a set of predefined procedures. Each procedure has a procedure’s name.

Consent Consents in medical are legal documents. The output of consents is the patients’ decisions of their healthcare.

TreatmentConsent

Is Consent. It is asked by treatment procedures based on state, federal laws or sub-disciplines regulations. Each consent for the treatment procedures associate with a name. For example, anesthesiaconsent

MandatoryConsentis a sub-class of TreatmentConsent. It must be active consent which allows doing treatment procedures. Even the same consent may be a mandatory consent in some cases, such as anesthesia consent for a surgery

OptionalConsentIs a sub-class of TreatmentConsent. But its omission does not affect performing procedures. Such as anesthesia consent for giving birth, the patient does not have to give such consent.

AdultPatientIs a patient with maturity status. Competent adult patient allow giving their treatment consents. If an individual belongs to this class mean that individual is an adult patient.

MinorPatientIs a patient. It is opponent of adult patient, without exception, such as emergency, etc. Minor patients do not allow giving treatment consent by themselves.

PerformInState Is a State. They associate with Treatment.

Properties  in  Medical  Consent  Domain

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Properties Domain Rang RelationsasksMandatoryConsentByPatient

Patient MandatoryConsent It would link individuals belonging to the class Patient to individuals belonging to the class MandatoryConsent.

asksOptionalConsentByPatient

Patient OptionalConsent It would link individuals belonging to the class Patient to individuals belonging to the class OptionalConsent.

has Treatment ProceduresIt would link individuals belonging to the class Treatment to individuals belonging to the class Procedures.

isPatient AdultPatient and MinorPatient Patient

It would link individuals belonging to the classes AdultPatient and MinorPatient to individuals belonging to the class Patient.

isState PerformInState StateIt would link individuals belonging to the class PerformInState to individuals belonging to the class State.

needsMandatoryConsent Procedures MandatoryConsent

It would link individuals belonging to the classes Procedures to individuals belonging to the class MandatoryConsent.

needsOptionalConsent Procedures OptionalConsentIt would link individuals belonging to the classes Procedures to individuals belonging to the class OptionalConsent.

performedIn Treatment StateIt would link individuals belonging to the classes Treatment to individuals belonging to the class State.

requiresMandatoryConsent Procedures ConsentIt would link individuals belonging to the class Procedures to individuals belonging to the class Consent.

requiresOptionalConsent Procedures ConsentIt would link individuals belonging to the class Procedures to individuals belonging to the class Consent.

Screenshot  of  Protégé

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Reasoning  Example

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This  is  an  example  to  show  the  use  of  the  inference  engine:  A  15  year  old  patient  named  Kate  seeks  an  eye  surgery  (treatment)  in  California  (CA)  with  the  following  characteristics  -­‐  she  does  not  live  with  her  parents  and  manages  her  own  financial  affairs.  

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Real  World  Consent  form

Detailed  Architecture  of  Consent  Management  System

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Controlling  Consent  Management  System  using  WfMS

*  Case:  refers  to  a  specific  instantiation  of  a  work  flow  model/workflow  specification      Work  item:  refers  to  an  instance  of  a  task  

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