Post on 27-Jun-2020
Las Palmas November 18 – 20th 2016
Dr Richard Fitton, Dr Syed Ghulam SarwarShah D Amir Hannan
“Electronic Health records and the European Union –current legislation and future
directions. A perspective”
I am a working mum looking after a small child, a part-time job, a husband, a house… I also have Diabetes, an under-active Thyroid, fertility problems, depression, asthma and recently started medication to protect my kidneys!
I don’t have time to be ill!
I now order my prescriptions, book my appointments to see the doctor, check my test results and sometimes I even go over the conversation I had in my consultation with the Doctor when I feel I need to clarify issues.
I shop online, I communicate online, I educate myself online, I control my finances online. In 2007 it’s only right that I look after myself ONLINE.
The doctor and patient create the record together
• They record the symptoms, signs, examinations, results, tests, diagnoses, follow up plans and management plans
• The patient can reuse the record whenever they want and share it with whoever they want
Silos of Health Information: Year Future
FOR ILLUSTRATIVE PURPOSES ONLY
How do we regulate the global health
records?
Hadfield Medical Centre patients’ model
• In 20043 a group of patients were asked to examine their own complete medical reccord in an English General Practice setting and to mark those parts of the record that they would not want to share with a national care record. As expected the patients chose parts of their records that had a social context as well as a health service context.
Patient Care Record (Extracted from Torex)
PRINT RECORD_DATE,CODE,VALUE1,VALUE2,TEXTFROM JOURNALS (ALL FOR PATIENT)
WHERE NHS_NUMBER IN (“**********")*RSP_IDENT,HMC,Hadfield Medical Centre *RSP_AUTHR,USER1,Temporary HQL User *RSP_RDATE,********,**/**/****&1,"RECORD_DATE","CODE","VALUE1","VALUE2","TEXT"$1,"20000628","-12","","","*PROMPT* Check family history"$1,"20000628","-136","","","*PROMPT* Ask about alcohol"$1,"20000628","-137","","","*PROMPT* Smoking history"$1,"20000628","-229","","","*PROMPT* Check height"$1,"20000628","-22A","","","*PROMPT* Check weight"$1,"20000628","-22K","","","*PROMPT* Calculate BMI"$1,"20000628","-246","","","*PROMPT* Blood Pressure Check"$1,"20000118","06..","","","Managerial occupations - ********. -"$1,"19950208","23..","","","Examn. of respiratory system - nad."$1,"19950208","2D..","","","Ear, nose + throat examination - nad."$1,"19990222","2DC1","","","O/E - pharynx hyperaemic"$1,"19990224","41B3","","","Faeces test due"$1,"19960124","652.","","","Typhoid vaccination typhim vi lo411 4.98 given"$1,"19960124","6564","","","Booster tetanus vaccination e54452u 97.01"$1,"19960124","6584","","","Booster polio vaccination s124j10 8.96"$1,"19960124","65C.","","","Yellow fever vaccination given"$1,"19960124","65FA","","","1st hepatitis A vaccination vha419b6 7.96 right"$1,"19951205","67E1","","","Recommend travel vaccinations, enquiry re"$1,"20021017","934Z","","","Computer record NOS-request"$1,"20000202","982A","","","Night visit claimable - higher"
Hadfield Medical Centre patients’ model
• We used the following common coded ICD10 (International Classification of Diseases) roots from the GP record and produced a data engine that put them into the following unique folders. The patient then marked the folders that they did not want to share without consent at each attendance or health data interaction and those that they would share within a regulated health service environment.
Hadfield Medical Centre patients’ model
• Disease categories• Infectious/parasitic diseases• Neoplasms• Endocrine/metabolic• Blood diseases• Mental disorders• Nervous systems/senses
Hadfield Medical Centre patients’ model
• Disease categories
• Circulatory disorders• Respiratory• Digestive system• Genito-urinary system• Pregnancy/childbirth/puerperium• Skin/subcutaneous tissue
Hadfield Medical Centre patients’ model
• Disease categories• Musculoskeletal• Congenital abnormalities• Perinatal conditions• Symptoms, signs and ill defined
conditions/working diagnoses• Injury/poisoning• causes of injury/poisoning
Hadfield Medical Centre patients’ model
• These parts of the record that patients did want to be shared with a national record:
• Infectious diseases, • Drug and alcohol problems, • Mental and social health issues, • Sexuality – including pregnancy and
contraception • Genetics.
• A browser-based viewer for displaying personal health data from specified sources• Structured user friendly interface that can utilise all the patient data delivered from
floppy disc, CD or other secured location• Will link to the internet for further information for a given disease, condition, treatment
or drug. • Structured according to the World Health Organisation international classification of
disease.
The patients produced a pictorial template for their moral choices
Selection and display
• At the category selection page animated icons change from the category icon to the “invitation to view” icon and back again which indicates current conditions or issues.
• Clicking on the desired icon will show the record detail for that disease category.
Health Record standards
a) Clinical standards and clinical governance b) Technical standards c) Information Standards d) Security standardse) Ethical and moral standardsf) Legal standards g) Cultural standardsh) Resource standards
European legal requirements
European convention on human Rights
EC 95/46
European General DataProtection Regulation
European legal requirements• The European Commission at Brussels
COM(2012) 11/4 draft2 is a proposal for a regulation of the European parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation {[SEC(2012) 72} ] and {[SEC(2012) 73}].
European moral requirements
• Main article: Article 8 of the European Convention on Human Rights
• Article 8 provides a right to respect for one's "private and family life, his home and his correspondence", subject to certain restrictions that are "in accordance with law" and "necessary in a democratic society".
European moral requirements
• Article 9 provides a right to freedom of thought, conscience and religion. This includes the freedom to change a religion or belief, and to manifest a religion or belief in worship, teaching, practice and observance, subject to certain restrictions that are "in accordance with law" and "necessary in a democratic society"
European moral requirements
• Article 10 provides the right to freedom of expression, subject to certain restrictions that are "in accordance with law" and "necessary in a democratic society". This right includes the freedom to hold opinions, and to receive and impart information and ideas
Overarching moral requirements
• The corollary of these observations is that a nation cannot legislate uniformly for the morality of each of its citizens’ when supporting information technology. It can however support a model of consent and confidentiality if it creates legislation that models the biological models of ethics.
Overarching global legal requirements
• This paper suggests that national solutions for personal health data processing should include technology to allow citizens to specify which data they do not want sharing.
• There are other international requirements that we would wish to see which are outlined further in the paper.
Other international requirements that we would wish to see
• Data controllers (GPs in our particular case) should no longer be able to refuse online access to data subjects to all of their real time digital data if the technology can allow this access.
• Data subjects should have the option of being part of a dynamic and ongoing process of deciding which pats of their data are sensitive.
Other international requirements that we would wish to see
• Patient sensitive data (as defined by the patients as they view their data as it is being created with real time access to data that current technology allows– or later as they view it through their access rights) should be digitally coded and recorded at source as processing takes place.
Other international requirements that we would wish to see
• Patient sensitive data (as defined by the patients as they view their data or later as they view it through their access rights) should be digitally coded and recorded at source as processing takes place.
• Data subjects should have an opportunity to be involved in the decisions that are made about the retention and destruction of their data.
Other international requirements that we would wish to see
• Data subjects should have an opportunity to be involved in the decisions that are made about the retention and destruction of their data.
• The law should include a requirement for states to include privacy educational in their national educational curricula.
Other international requirements that we would wish to see
• Digital audit trails of access to personal data should be made available to the data subjects.
• Data controllers should be under statutory obligation to publish on their public facing websites the information sharing contracts that they have made with other data controllers for the processing of sensitive personal data.
Other international requirements that we would wish to see
• Data controllers should be statutorily required to publish the details of data and parties involved in the information flows of sensitive data.
• Data controllers should be obliged to publish the details of bulk transfers of personal data that they make from one data controller to another and to automatically log which data controllers have accessed a data subject’s data.
The International Festival of Public Health UK 2015
Dr Richard Fitton
“The legal, public and philosophical considerations for
global health data processingby citizens, state and public health
professionals.”
FOR ILLUSTRATIVE PURPOSES ONLY
Global Health data processing - The history of health data and health
records
Egyptian permanent messages - hieroglyphics
Dead Sea Scrolls
A conceptual diagram tool from Gray’s anatomy
Writing a medical record
Paper records
Central digital storage and manipulation of data - Valve computer
Central digital storage and manipulation of data Smaller
computer
Central digital storage and manipulation of data Laptop
Central digital storage and manipulation of data - Family doctor
office
Central digital storage and manipulation of data - Hospital
Cloud computing
Datafarm
Linking clinicians, patients and records
Silos of Health Information: Year Future
ICUH 2009
• Rural settingShared Health Records as transporters of memes
Global health data processing• the laws• The Citizen as a partner in global data processing• Consent, education, testing understanding and
dynamic consent• The clinical and public health paradigms for data• how can we record data for universal use?• How can citizens express how and which bits of
their data can be shared?• What we want the WHO to consider
Global health data processing –
the laws
Data protection enactment around the world
Current The European Data Protection Directive 95/46/
25
European Commission
• The European Commissionis the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union’s Treaty and the general day-to-day running of the Union.
26
European E-intelligence overcomes national boundaries
27
Member States of the European Union
“Nine out of ten Europeans (89%) say it is important for them to have
the same rights and protections over their personal information,
regardless of the country in which the authority or private company
offering the service is based.”
•“Seven out of ten people are concerned about their information being used for a different purpose from the one it was collected for.”
•“Two-thirds of people find it important to be able to transfer personal data to a new online service provider. This means, having the right to 'data portability'.”
“Six out of ten respondents say that they do not trust online businesses
(63%) or phone companies and internet service providers (62%). And our
reform can restore this trust, by giving back control over people's data.”
In January 2012, the European Commission proposed a comprehensive reform of data protection rules in the EU. The completion of this reform is a policy priority for 2015.
The objective of this new set of rules is to give citizens back control over of their personal data, and to simplify the regulatory environment for business.
Cameron Kerry, joined Governance Studies and theCenter for Technology Innovation at Brookings. Kerryserved as General Counsel and Acting Secretary of the UnitedStates Department of Commerce,
http://www.brookings.edu/~/media/research/files/papers/2014/05/20-europe-privacy-surveillance-kerry/kerry_europefreetradeprivacy.pdf
“The conversation between the United States and Europe about data privacy has been through many twists and turns over the past year.”
The EU and the USA
“This has never been an easy conversation. Despite a great deal in common, differences in attitudes and legal systems have accentuated the differences that exist around privacy. And the Snowden disclosures turned the conversation into more of a scolding.”
“But as the initial anger subsides and the administration takes steps to affirm America’s commitment to protecting privacy at home and abroad, it may be possible to resume a genuine give-and-take.”
“There is a great deal at stake, because the transatlantic economy accounts for 50percent of the world’s GDP.
Digitally-enabled trade flows in and out of the United States amount to more than $500 billion, a rough measure of the value of data flows, and the largest share of these by far is with Europe.”
“This is why discussions of theTransatlantic Trade and Investment Partnership (TTIP) and mechanisms for the flow of digital information and protection of private data are significant.
The profound reaction to the Snowden disclosures in Europe, Brazil, and elsewhere have brought home just how large these issues loom on the global stage.”
Global health data processing – The
Citizen as a partner in global data processing
Citizens and information are the most under-utilised resources in health service provision
Patient Access
to Record
Patient
Autonomy
Patient
Partnership
Patient
Contribution to Record
38
Local citizens as health resources
• Citizens will become central resources for their own healthcare and will simultaneously create their own health record
• Computers the internet and information technology provide the data, understanding, knowledge, skills and attitudes that citizens require
I am a working mum looking after a small child, a part-time job, a husband, a house… I also have Diabetes, an under-active Thyroid, fertility problems, depression, asthma and recently started medication to protect my kidneys!
I don’t have time to be ill!
I now order my prescriptions, book my appointments to see the doctor, check my test results and sometimes I even go over the conversation I had in my consultation with the Doctor when I feel I need to clarify issues.
I shop online, I communicate online, I educate myself online, I control my finances online. In 2007 it’s only right that I look after myself ONLINE.
Clinical pathways in practice
Pathways translated into computer language Algorithms
44
The electronic record is shared by mobile and internet technology
• Patients, families and carers can see the record at home and abroad
• Patients can share the record at other healthcare record provider sites
• Service commissioners and public health can use the data according to local legal and professional standards
Global health data processing –
Consent, understanding and dynamic consent
UNIVERSAL DECLARATION OF HUMAN RIGHTS the balance will vary from state to state and from citizen to
citizen• Article 3.
– Everyone has the right to life, liberty and security of person.
• Article 12.– No one shall be subjected to arbitrary interference
with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation.
47
Lessons learned:
48
Lessons learned: NPFITechnology
49
Consent for sharing and using data how can you consent to data being
seen if you have not seen it yourself?
• N… was a woman with diabetes who gave birth by vaginal delivery. Her baby, S.., was born with serious disabilities after shoulder dystocia during delivery. The doctor did not tell N… of the 9-10% risk of shoulder dystocia. The doctor said that she did not routinely discuss the risk of shoulder dystocia with women with diabetes for fear that, if told, such women would opt for a caesarean section. The court held that the doctor should have informed N…. of the risk and discussed with her the option of a caesarean section.
Data Sharing Review Report
51
http://amberhawk.typepad.com/files/thomas-walport-datasharingreview2008.pdf
Richard Thomas, UK Information Commissioner, 2002-2009Sir Mark Walport, Director and Chief Executive of the Wellcome Trust
Data Sharing Review Richard Thomas Mark Walport
• 4.11 In summary, the poor level of public trust and confidence in the sharing of personal information provides a critical backdrop to this review .... and highlights the need for substantial improvements in the ways that organisations handle personal information.
52
Conclusion
The UK Biobank(http://www.ukbiobank.ac.uk/)
provides a classic exemplar of how patient data should be collected and
managed.
UK DPA1 Principles for the data subject consent
1. Personal data shall be processed fairly and lawfully
2. Personal data shall be obtained only for one or more specified and lawful purposes
3. Personal data shall be adequate, relevant and not excessive
4. Personal data shall be accurate and, where necessary, kept up to date.
1The UK Data Protection Act 1998 54
UK DPA Principles for consent5. Personal data processed for any purpose or
purposes shall not be kept for longer than is necessary
6. Personal data shall be processed in accordance with the rights of data subjects
7. Appropriate technical and organisational measures shall be taken against unauthorised or unlawful processing and ... loss or destruction or damage
8. Personal data shall not be transferred to a country or territory outside the European Economic Area unless ...
55
UK DPA data subject rights
• Right of access to personal data • Right to prevent processing for purposes of
direct marketing • Rights in relation to automated decision-
taking • 14 Rectification, blocking, erasure and
destruction • Compensation for failure to comply with
certain requirements
Global health data processing – The clinical and public
health paradigms for data
58
Life, health, independence, disease
59
Clinical pathways in practice
The Future
Artificial data engines will seek out information from the patient’s information repositoryto populate empty fields within new or repeated clinical pathways. Data engines willmatch and link codes from the data repositories to codes attached to original research,local service provision information, local service outcome information and national orinternational standards, allowing patients to rapidly increase their own knowledge base.
Global health data processing – how can
we record data for universal use?
A written record cannot be interpreted and shared efficiently digitally
Chinese data cannot be read in Poland
Arabic data cannot be read in China
Polish data cannot be read in China or Arabia
Machine readable codes can be read any where
Telephone number Unique identifier are recognised worldwide
SNOMED CT
The delivery of a standard clinical terminology for use across the world's health information systems.
The codes are virtual representations of The systems of the body –
InfectionNew growths - neoplasiaGrowth, endocrine and metabolismBlood and clottingBehaviour, thought, emotionNervous systemCardiovascular systemRespiratory system
The codes are virtual representations of The systems of the body –
• Genitourinary system• pregnancy and reproduction• Skin• Vertebrae and musculoskeletal system • Neonates and infants• Accidents and poisoning• Ageing and dying• Functional ability and disability
Digital Patient Care Record (Extracted from Torex)
PRINT RECORD_DATE,CODE,VALUE1,VALUE2,TEXTFROM JOURNALS (ALL FOR PATIENT)
WHERE NHS_NUMBER IN (“**********")*RSP_IDENT,HMC,Hadfield Medical Centre *RSP_AUTHR,USER1,Temporary HQL User *RSP_RDATE,********,**/**/****&1,"RECORD_DATE","CODE","VALUE1","VALUE2","TEXT"$1,"20000628","-12","","","*PROMPT* Check family history"$1,"20000628","-136","","","*PROMPT* Ask about alcohol"$1,"20000628","-137","","","*PROMPT* Smoking history"$1,"20000628","-229","","","*PROMPT* Check height"$1,"20000628","-22A","","","*PROMPT* Check weight"$1,"20000628","-22K","","","*PROMPT* Calculate BMI"$1,"20000628","-246","","","*PROMPT* Blood Pressure Check"$1,"20000118","06..","","","Managerial occupations - ********. -"$1,"19950208","23..","","","Examn. of respiratory system - nad."$1,"19950208","2D..","","","Ear, nose + throat examination - nad."$1,"19990222","2DC1","","","O/E - pharynx hyperaemic"$1,"19990224","41B3","","","Faeces test due"$1,"19960124","652.","","","Typhoid vaccination typhim vi lo411 4.98 given"$1,"19960124","6564","","","Booster tetanus vaccination e54452u 97.01"$1,"19960124","6584","","","Booster polio vaccination s124j10 8.96"$1,"19960124","65C.","","","Yellow fever vaccination given"$1,"19960124","65FA","","","1st hepatitis A vaccination vha419b6 7.96 right"$1,"19951205","67E1","","","Recommend travel vaccinations, enquiry re"$1,"20021017","934Z","","","Computer record NOS-request"$1,"20000202","982A","","","Night visit claimable - higher"
G 30.9 + is the standard ICD code for a class of dementia – machine readable
Fractured humerus M84.429D machine readable
Global Health data processing – How can
we allow citizens across the world to
express which bits of their data can be
processed?
Patient Care Record (Extracted from Torex)
PRINT RECORD_DATE,CODE,VALUE1,VALUE2,TEXTFROM JOURNALS (ALL FOR PATIENT)
WHERE NHS_NUMBER IN (“**********")*RSP_IDENT,HMC,Hadfield Medical Centre *RSP_AUTHR,USER1,Temporary HQL User *RSP_RDATE,********,**/**/****&1,"RECORD_DATE","CODE","VALUE1","VALUE2","TEXT"$1,"20000628","-12","","","*PROMPT* Check family history"$1,"20000628","-136","","","*PROMPT* Ask about alcohol"$1,"20000628","-137","","","*PROMPT* Smoking history"$1,"20000628","-229","","","*PROMPT* Check height"$1,"20000628","-22A","","","*PROMPT* Check weight"$1,"20000628","-22K","","","*PROMPT* Calculate BMI"$1,"20000628","-246","","","*PROMPT* Blood Pressure Check"$1,"20000118","06..","","","Managerial occupations - ********. -"$1,"19950208","23..","","","Examn. of respiratory system - nad."$1,"19950208","2D..","","","Ear, nose + throat examination - nad."$1,"19990222","2DC1","","","O/E - pharynx hyperaemic"$1,"19990224","41B3","","","Faeces test due"$1,"19960124","652.","","","Typhoid vaccination typhim vi lo411 4.98 given"$1,"19960124","6564","","","Booster tetanus vaccination e54452u 97.01"$1,"19960124","6584","","","Booster polio vaccination s124j10 8.96"$1,"19960124","65C.","","","Yellow fever vaccination given"$1,"19960124","65FA","","","1st hepatitis A vaccination vha419b6 7.96 right"$1,"19951205","67E1","","","Recommend travel vaccinations, enquiry re"$1,"20021017","934Z","","","Computer record NOS-request"$1,"20000202","982A","","","Night visit claimable - higher"
• A browser-based viewer for displaying personal health data from specified sources• Structured user friendly interface that can utilise all the patient data delivered from
floppy disc, CD or other secured location• Will link to the internet for further information for a given disease, condition, treatment
or drug. • Structured according to the World Health Organisation international classification of
disease.
Foldercare Is ………
The Future
Artificial data engines will seek out information from the patient’s information repositoryto populate empty fields within new or repeated clinical pathways. Data engines willmatch and link codes from the data repositories to codes attached to original research,local service provision information, local service outcome information and national orinternational standards, allowing patients to rapidly increase their own knowledge base.
Global health data processing – What
we want the WHO to do
The WHO, the United nations and our submission from the ICMCC and IWEEE
•Dr Margaret Chan
• Director-General• World Health Organization•• Email: chanm@who.int•• Dear Margaret•• I would like to bring to your attention the e-health work regarding the International Council on
Medical & Care Compunetics (ICMMC) on patient electronic health records. A group of their members would like to meet with your officials and present a submission around incorporating access to the clinical health record and access to Electronic Health Records as part of the WHO current e-health strategy.
•• I think it would be a good opportunity for WHO to engage with their work. I have copied in
signatories of the group who wish to present their submission and meet. These are Dr Brian Fisher, Dr Richard Fitton and the president of the ICMCC Dr Lodewijk Bos.
•• Yours sincerely•• SIR LIAM DONALDSON• CHIEF MEDICAL OFFICER
WHO SUBMISSION (Draft) 1. AIM:
To ensure that patient record access (RA) is incorporated in WHO development plans.
WHO SUBMISSION (Draft) 1.
5. ACTIONS FOR THE WHO 5.1 The WHO will recognize the significance benefits accrued by full RA to the electronic health record. 5.2 The WHO will promote RA as a key aspect of care and information governance.
ICMCC and IWEEE
5.3 The WHO will ensure that health services around the world enable patients to see their full personal health record if they want to. The administrative, cultural and technical infrastructure to support RA should be encouraged. 5.4 The WHO will support research into RA and how it can be best harnessed for patient care.
ICMCC and IWEEE
United Nations submission
• The UN will ensure that health services around the world enable patients to see their full personal health record if they want to. The administrative, cultural, governance and technical standards to support personal health records should be supported by the UN.