Accessing the data

There are three layers of data that researchers want to, or could use to drive improvements in healthcare (both in medical research and commissioning models)
  • Clinical usage data- physical healthcare utilization
  • Platform data (PKB usage stats)- how patients use digital healthcare
  • Transaction data (eg actual blood test results, treatment regimes, etc) - outputs from an actual person to person transactions 

There are two approaches to use PKB for research purposes. 

First, clinical teams that have access to a patient's record can provide extracts to researchers if their information governance team approves that no explicit consent is needed from patients. Examples for this include audits of the clinical service to assess patient care. The patient does not need to do anything. 

The second approach is to explicitly consent the patient to link their record to the research team.

Explicit consent to access data for research

There are three ways to do this:

  1. The patient can explicitly click to link their record to the research team through the registration page of the research team.
  2. An existing non-research team with consent to use the patient's record consents the patient to share data with the research. The Non-research team then adds the research team to the patient's PKB record using PKB's web site without the patient having to do anything. The patient and carer are notified by e-mail that this happened.
  3. An existing non-research team with consent to use the patient's record consents the patient to share data with the research. The Non-research team's computer system then adds the research team to the patient's PKB record using the PKB API without the patient having to do anything. The patient and carer are notified by e-mail that this happened.
  4. For as long as the research team has access to a patient's record they can see the data using the PKB web site and they can copy the data using the PKB API.

Managing sharing with research teams

At any time the patient, carer and professionals can see which teams have access to the patient's record. At any time the patient – or the carer or professional on behalf of the patient – can stop sharing with any team.

Data quality in this very important field is of surprisingly bad quality (poor coding techniques, anonymization techniques that leave it useless for evaluating impact from innovation) and quantity (incentives have generated pockets of very well recorded data in some areas, leaving whole other metrics unevaluated e.g. QOF data). Typical of a silo'd approach there are a confusing number of different datasets and coding mechanisms (SNOMED- the phone book of impairments, READ- the phonebook of intervention) with a lot of overlap and gaps- here are but a few mandatory datasets currently in NHS England:
  • HES (hospital episode statistics) data record of admission length, what happened and roughly who you are (geography, age, ethnicity)
  • SUS (secondary uses service) data warehouse of (identifiable) patient-level data on secondary care utilization
  • QOF (quality and outcomes framework) Primary Care data on achievement of specified results by GPs 
  • CIDS (community information data set) Local data collection on patient-level outputs in community care
  • MCDS (Maternity and Children's Data set) data submitted by maternity and children's' services on outputs from their interventions
As a result emerges the typical NHS style matrix style of layering confusion upon layer of confusion of what needs to be recorded, how and sent to where... to already busy clinicians.

Data organized by PKB

PKB has value because as a whole platform it houses data on physical healthcare utilization ("encounters"), digital healthcare utilization (invaluable data on what patients do when they are not physically in the presence of a medical professional/ in the building... ie most of the time) and transaction data (blood, measurements, care plans, and assessments).
  • PKB can report identifiable datasets that can be linked over time
  • PKB can segregate and assimilate data from multiple sources (eg mental health, social care, and health) due to our consent model and privacy labels
  • PKB can send the data where it needs to go without process, duplication and a push of the button (eg ICPATH)

Data and patient control

  • Personal data is subject to the data protection act which prevents harm to identifiable people subject to that data. 
  • Almost any type of data could be described as "personal data" if it relates to an individual, the acid test is whether the person could be identified from that data. If they can't, it's not personal data. If it can be re-identified (even if you had to put in a massive effort to re-identify an individual) there are legal consequences to misusing this data (using it without consent).
  • Without consent, you cannot use any personal data (unless you are a healthcare professional performing system evaluation or clinical audit to evaluate planned activity already underway).
This poses three specific consequences when PKB is used: 
  • PKB disrupts the traditional research model
Due to our consent model and privacy labels, patient consent is informed (they can exercise their wishes), consistent (applied across all their data records) and responsive (patients can change their minds and be flexible about access). This means the patriarchal model of ethics boards for routine research, not involving vulnerable people, is obsolete.
  • PKB empowers patient participation (and reward) in research
Researchers can be linked directly to patients, making patient recruitment and retention more efficient and cost-effective. It also improves the relationship of patients to charities and third sector organizations, propelling patient-led (rather than clinician-led) research objectives and methodologies.  

Research trials can also be linked to patients. With some clever automation using the coding mechanisms present within healthcare datasets, PKB will be able to "advertise" to patients with certain impairments/ diagnoses, the relevant trials that may be of interest to them (CRUK work). 
  • PKB facilitates innovation within rules and regulation
PKB dataset will become the most comprehensive and best-organized data set available. The patient consent model and technological capabilities will drive medical innovation. PKB delivers to a big data strategy and rewards.