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DATA PROTECTION ISSUES Dr Julian Brown. Diabetes Manager – Caldicott 1  Justify the Purpose  Developed for three reasons:  My Diabetes Patients were.

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Presentation on theme: "DATA PROTECTION ISSUES Dr Julian Brown. Diabetes Manager – Caldicott 1  Justify the Purpose  Developed for three reasons:  My Diabetes Patients were."— Presentation transcript:

1 DATA PROTECTION ISSUES Dr Julian Brown

2 Diabetes Manager – Caldicott 1  Justify the Purpose  Developed for three reasons:  My Diabetes Patients were not getting the information they needed to optimise their care.  Integrated Care was not happening in my PCT  Patients at risk were not being picked up in both my surgery and in my PCT (I have been Prescribing Lead since 2006)  Diabetes Manager will improve Patient Care, Reduce waiting times, Improve Education, Empower the Patients and Save Lives.

3 Diabetes Manager – Caldicott 2  Don’t Use Patient Identifiable Data Unless Absolutely Necessary.  Every Other Patient Summary Records Uses PID  This is not acceptable for any cloud based technology.  It is not necessary.  No Patients Names, Addresses, Telephone Numbers, NHS numbers are stored on our Remote Server. NHSpatient.org was Carefully Created to allow maximal integration of care whilst protecting the privacy of the Patient.

4 Diabetes Manager – Caldicott 3  Use the minimum necessary patient-identifiable information.  No Name, DOB, Address, Telephone Number, , Hospital Number  After Discussion with GPs, Diabetes Consultants, Diabetes Nurses and Patients:  All conditions Read Codes  All medications  All Blood Results  Patient’s Treatment Plan  Risk Alerts  Users with Access to the Patients Record

5 Specific Concern  I don’t think you can justify extracting someones HIV status/sexual history etc (for a DM project) “because we might use it for other CDM in the future.”  Diabetes affects or is affected by most conditions.

6 SPC sheets Kaletra (lopinavir)  Special Warning – “Hyperglycaemia”  “New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors. In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many patients had confounding medical conditions some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.”  Blood Glucose Elevation reported as common

7 SPC Norvir (ritonavir)  Special Warning  Diabetes mellitus and hyperglycaemia: New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors. In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia

8 SPC Atripla (efavirenz,emtricitabine,tenofovir)  Boxed Special Warning  “Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues. Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness). Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure. Lactic acidosis generally occurred after a few or several months of treatment.”  Common SE “Hyperglycaemia”  Interacts with Statins

9 Diabetes Manager – Caldicott 4  Access to PID should be on a strict need to know basis.  Only those that need it.  Only have access to the information they need.  PID!  Access Controls  2 factor authentication  Data Splitting  Read Code Filtering  Complete log file of who accessed who at what time.

10 Diabetes Manager – Caldicott 5 Everyone with Access to PID should Be aware of their responsibilities:  Within Our Organisation.  Within the Hosting Company.  Within Your Organisation.  Only Steven and James have access to the database which contains no PID.  Your Data will be stored a maximum security UK server. (the bunker.net) with full ISO27001 governance.

11 Diabetes Manager – Caldicott 6  Understand & Comply With the Law  Diabetes Manager, Eclipse Solutions and NHSpatient.org all comply with the Date Protection Act, NHS regulations and the NHS confidentiality code of practice.  Many alternative programs do not

12 Extra Issues - 1  Patients that Have signed out of the NHS Spine will not have any data extractions.  There is an ability for these patients to sign back in using a specified read code.

13 Data Should be Hosted Securely  ISO27001  24 hour security  Nuclear Bunker  NHS Approved  Proven Track Record  Stand Alone Server  content/uploads/2013/02/casestudyCimarFINAL.pdf

14 Should Be Excellent Disaster Recovery  SAN Hard Drives  Industrial Level Servers  Onsite Back up  24 hour support  Continual Automated Tracking

15 Clear Data Protection Statements  We look after your Patient’s data securely and reliably.  Your GPs have complete governance over who has access to data relating to their patients.  Phase 2 will allow patients to control this.  No data is passed onto third parties without permission.  Currently most GP systems already do this.

16 Projects with Third Parties  NHS England – David Cousins, David Garrett and Professor Tony Avery (Patient Safety Project)  Cambridge Cancer Research Network.  Imperial College Global Research Unit (Sir Tom Hughes-Hallett)  Opt in only

17 Projects with Pharmaceuticals  Essential for the future of R&D  Anonymised Data Only.  Can create significant revenue for the Practices and the CCG.  Similar Principles to Dispensing.  Opt in only.  The aim is to have IT creating revenue for your organisation whilst improving patient care not utilising it.

18 Data Integration  It is essential that any IT databases utilised by the NHS can be used by standard equipment and integrate with secondary databases.  Diabetes Manager links with:  Prescribing Data  Referral / Admission Data  Blood Glucose Meters  BP machines.

19 Data Integration needs to be Accurate  Link through Patient Card  N3 Server integration  Links hospital number and nhspatient.org number  Allows secure mapping in restricted environment.  Allows removal of PID from admissions data whilst maintaining audit.  Needs Secondary Consent


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