Do summary care records have the potential to do more harm than good? Yes

Prof Kitzinger's response adds to the 'legal worries' expressed by Ross Anderson.Non-inclusion of Advance Decisions in SCR is surely a serious issue and cannot be compatible, among other things, with a patient's rights per Mental Capacity Act 2005. So what's next?

Competing interests:
None declared

The summary care record was, as Ross Anderson says, marketed to the
public as a way for A&E staff to check up on unconscious patients.
Envisaging such a scenario, the most important information I would want
staff to have is that contained in my Advance Decision, drawn up in
accordance with the Mental Capacity Act 2005, signed by witnesses and
lodged with my GP. It specifies the conditions under which I refuse CPR,
ventilation and other forms of life-preserving treatment.

Since the information leaflet about summary care records did not
mention Advance Decisions (which seemed an extraordinary omission), I
sought out more information about how they would facilitate A&E staff
access to them. The website referred to in the leaflet
(htpp://www.nhscarerecords.nhs.uk/faqs) has nothing on either Advance
Decisions (ADs) or Lasting Power of Attorney (LAPs). A phone call to the
NHS Care Records Service Information Line (0845 6038510) led to a
conversation in which the call-taker asked me "What is an Advance
Decision?" and - when I explained - advised me (wrongly) that as long as
my family knew what treatments I wished to refuse, all would be well.

Finally I wrote to the Chair of my PCT (East Riding of Yorkshire) and
received a response stating that Advance Decisions are not amongst the
"core information" initially included in summary care records. Apparently
only "medication, allergies and severe reactions" are to be included in
summary care records in the first stage. Advance Decisions are part of
subsequent possible "enrichment" programme. I was also horrified to read
that "The PCT does not provide training to its staff on ADs and LPAs"
(letter from Karen Knapton, 12 July 2010).

If the summary care record is of any practical use at all, it should
offer health care staff the opportunity to gain quick and efficient access
not only to information about patient medication and allergies but also
about our advance refusals of medical treatment in circumstances - such as
unconsciousness - in which we are unable to communicate these ourselves.
This opportunity has been missed and those of us who have Advance
Decisions are left feeling anxious and dismayed that summary care records
may make available just enough clinical information to keep us alive
against our wishes.

I have of course withheld permission for my own clinical data to be
transferred to a summary care record. The broader issue is the apparent
lack of awareness about patients' right to make advance refusals of
medical treatment, and the national implementation of a system of summary
care records designed in such a way as to ignore and override that right.

Competing interests:
None declared

The legal argument has been dealt with by Professor Korff, but it
cannot be considered apart from the technology. It is not possible for a
record available to 850,000 people to "exclude any possibility of
unauthorised access" as the law requires, and it is sophistry for SCR
advocates to argue that each of these 850,000 users is "authorised"
because they have an NHS smartcard. Even if you accept the current
"consent-to-view" model, access is only authorised if the patient has
given consent. Cardholders without patient consent are unauthorised, and
the system must prevent them from getting access, rather than merely
relying on their good behaviour. Furthermore, the Greenhalgh report tells
how as a practical matter consent is often not sought in a busy A&E
department; the patient is not seen by one clinician but by many, often in
very short encounters.

The fact that privacy does not scale is the fundamental problem here,
and one about which advocates of national-scale electronic patient records
appear to be in denial. You may be able to trust the two dozen people who
work for a general practice to behave appropriately but this consent model
cannot scale to almost a million people in the NHS. The "consent-to-view"
model is unserviceable, national-scale records will need a rather
different architecture.

It is also not true that most people accept the concept of national
electronic records to which large numbers of people have access. Repeated
studies of patient opinion since the debate over electronic medical
records began in the mid-1990s (e.g., [1], [2]) have confirmed that
patients are almost all willing to share records with clinicians involved
directly in their care; mostly willing to share records for research if
they're asked - and unwilling if they are not; but are generally unwilling
to share their records for wider purposes. That only 1% or so have opted
out is unsurprising; only a good mailshot achieves a better response than
this. The CfH mailshot did not set out the issues clearly and did not
include an opt-out form for patients to return. It was clearly designed to
minimise the response rather than maximise it.

Finally, freedom of information requests to the Department have
uncovered minutes of the National Clinical Reference Panel [3] which
disclose the intention to add PACS imaging history, A&E discharges and
even ambulance messages to the SCR. The view appears to be that the SCR
will become the long-awaited EPR, which in time will accumulate almost
everything. This will greatly exacerbate the safety and governance issues
I discussed in my article.

[1] Clinical Systems Security--Implementing the BMA Policy and
Guidelines", A Hassey, M Wells, in "Personal Medical Information--
Security, Engineering and Ethics",
Springer (1997)

[2] "Public Perspectives on the Governance of Biomedical Research: A
qualitative study in a deliberative context", V Armstrong et al., Wellcome
Trust (2006), at
http://www.wellcome.ac.uk/assets/wtx038443.pdf

[3]

http://www.connectingforhealth.nhs.uk/systemsandservices/scr/staff/advis...

Competing interests:
None declared

I disagree with Peter Singleton and agree with Ross Anderson about
the implications of the I. v. Finland judgment of the European Court of
Human Rights. Mr Singleton dismisses Ross Anderson's views because Ross
is not a lawyer. That may be true, but Ross, not Mr Singleton, is right
about the case. I am a lawyer, with considerable experience both at the
European Court of Human Rights and as a data protection expert.

Briefly, I. v. Finland (ECtHR Judgment of 17 July 2008, Application
No. 20511/03) was about alleged access by unauthorised hospital staff to
the medical records of the applicant, who was herself a nurse, and who had
been found to be HIV positive. In spite of rules supposed to protect the
confidentiality of her medical data, and of this diagnosis in particular,
her information does appear to have been improperly accessed by colleagues
at the hospital where she worked and who were not involved in her clinical
care (there was an issue in the Strasbourg proceedings about the onus of
proof in this respect, but that is irrelevant here - contrary to what Mr
Singleton says, it was not the central issue).

Specifically, the European Court of Human Rights upheld the
applicant’s argument that her medical data were not adequately secured
against unauthorised access at the material time. (para. 46)

The crucial passage in the ruling is the Court’s dictum that:

“the mere fact that the domestic legislation provided the applicant
with an opportunity to claim compensation for damages caused by an alleged
unlawful disclosure of personal data was not sufficient to protect her
private life. **What is required in this connection is practical and
effective protection to exclude any possibility of unauthorised access
occurring in the first place.** Such protection was not given here.”
(para. 47, emphasis by means of ** added)

The respondent State (Finland) had “failed in its positive obligation
under Article 8 § 1 of the Convention to ensure respect for the
applicant’s private life.” (para. 48) There had therefore been a
violation of Article 8 of the Convention. (para. 49).

As Professor Anderson has made clear, the SCR system as currently
being implemented is incapable of complying with the above ECHR standards
and thus, because the Convention is now part of UK domestic law, unlawful.
I fully endorse that conclusion.

Douwe Korff
Professor of International Law

London Metropolitan University

Competing interests:
I am a member of the FIPR Advisory Council and have advised the FIPR team that drafted the Database State report on the law.