New legislation being proposed in a clause in this year’s Health and Social Bill is just one of several examples from the UK that shows how very difficult it is to implement the protection of an individual citizen’s rights of choice to privacy in a fast-moving, fast-changing world — despite the Human Rights Act 1998. A trend of anti-confidentiality legislation is resulting.

Clause 68 of the Health and Social Care Bill ¹

Entitled Control of Patient Information, this clause has two parts with different objectives. Both propose to give the Secretary of State for Health very wide-ranging powers. Subclause 3 and its qualifiers make up the second part, which would enable the Secretary of State to determine how patient information would be processed for use in improving patient care or in the public interest.

One application of subclause 3 is described in subsection 4c. If used, it would introduce not only a new type of lawful breach of medical confidentiality but also waive the Data Protection Act’s requirements (which give effect to the rights of privacy given in the Human Rights Act) for data subjects to be informed and given the chance to either consent or object to the use of their identifiable medical data for secondary purposes. The indirect purpose is understood as medical research.

The powers and their use would be subject to safeguards. Subsection 4c is intended as both a reserve power and as a temporary measure.

The presence of this subsection is one of the Government’s solutions to a conflict that has arisen between established medical research practices and more recently introduced legislation — namely the 1998 Data Protection Act (DPA), the 1998 Human Rights Act, and the 2001 Freedom of Information Act.

The introduction of 4c appears to have originated from the traditional data-gathering methods of the UK’s cancer registries. Some other non-communicable disease registers and research databases collect data in similar ways.

The UK Association of Cancer Registries, which has lobbied for this proposed legislation, says that the DPA’s requirement for informed consent from the data subject is unworkable and would result in an unquantifiable loss of information and, therefore, quality. They also argue that registry records need to be person identifiable.²

The DPA’s stipulations have been publicised for over 5 years. While registry systems in other European countries have been redesigned to comply with the same requirements,³ UK registries appear not even to have tried to bring their methods of information gathering more into harmony with society's expectations in the 21st century.

The need for crisis management has been one consequence; there are also significant longer-term results.

The crisis was triggered by General Medical Council (GMC) guidelines sent to doctors, last autumn, about obtaining patients’ consent for the release of confidential information for medical research purposes. The UK Association of Cancer Registries argued that they need to record and monitor all incidences of cancer and to be denied this — as a result of the GMC guidelines, which would lead to incomplete reporting — the national system for monitoring cancers would collapse by the end of this year. From their point of view, subsection 4c must become law and be used to protect their work from the effects of the DPA.

The Government is in a difficult position: it has recently committed to a far-reaching modernisation of cancer-care services, based on evidence-based practice in which the cancer registries play an important role as knowledge makers. Any significant disruption to the information provided by the cancer registries, therefore, could be detrimental to the programme of reform, which is on a tight schedule.

Longer-term consequences, which include threats to existing research and unfavourable changes in attitude to medical researchers in the UK, are clearly pointed to in a succinct analysis prepared last month by Ross Anderson, Rudolf Hanka and Alan Hassey.³

The patient–clinician relationship

By far the most worrying of all the detrimental long-term consequences of using the powers proposed in subsection 4c is that it will spark a fundamental shift in the relationship of trust between patients and their doctors, nurses and therapists. It is a relationship based on faith that confidences will be kept and respect shown for the wishes and beliefs of patients. The value of this ethic has been proved time and time again in preventing harm. Use of the powers of 4c, however, would enforce an, as yet, unjustified breach of confidentiality and "is without any requirement that the individual be told that information will be shared, never mind being given the opportunity to object".⁴

Introduction of a new justification for breaching medical confidentiality

Prior to the 1998 Human Rights and Data Protection Acts, research data could be extracted, or passed on, lawfully from NHS records without either the knowledge or the consent of the data subject. The 1998 Acts, however, moved ownership of data usage from data controllers and users to data subjects. At present, therefore, each patient holds the right to decide who may use his/her medical information for secondary purposes, except in special circumstances accepted by society as being in the interests of all — for example, in the case of certain infectious diseases (when patients are notified of the disclosure, but may not object).

The case for adding collection of medical research data to the list of sanctioned instances when information may be disclosed to third parties and confidentiality lawfully breached has not yet been re-argued in light of changes in society’s values in recent years. To introduce it, albeit as an emergency measure, sets precedents. Is such a unilateral declaration fair?

If the issue comes to be debated and is not swept aside in pursuit of some other goal, the precedents of the now outdated data-collection practices together with the legitimisation of 4c will be used to argue strongly for the continuation of just what the Data Protection and Human Rights Acts are there to prevent: the disempowering of the freedom of the individual. The motive behind such argument will be the saving of cost and disturbance, inevitable in any change where the benefits of change are indirect or solely for others.

The introduction of subsection 4c to our laws sets other dangerous precedents, whose natures and implications have barely been explored, the haste in which this proposed legislation has entered the law-making system being one of them.

Time to think, time to plan

The Bill is being rushed through Parliament in order to be enacted before the imminent General Election and there are indications that subsection 4c was a last-minute inclusion.

Its presence took practically all affected parties by surprise, as prior to its publication on 21 December there had been no public briefing or debate on its proposals; neither had there been consultation with either patient-interest groups or healthcare professionals. Uproar ensued along with misunderstandings and misconceptions, compounded by drafting that was difficult to understand and insufficiently comprehensive explanations from government ministers.

The past 15 weeks have seen frantic activity by both proposers and opposers of c68, as a result. Passage through the debate stages in the two houses of parliament represents the first open consultation on the issues the clause attempts to take forward. Amendments have brought some clarity to the intentions of the Government – definitions of meaning and extents of the powers have become more precisely described. In all, though, it seems to be a risky method of introducing sensible laws based on balanced argument.

Meanwhile, in what appears to be the bringing forward of plans at great speed, the Government has clearly signalled its intentions to change research practice and show its commitment to the practice of informed consent. The Research Governance Framework was announced last month. Among other things, it aims to ensure that informed consent is obtained from participants in research programmes.⁵ Earlier, Gisela Stuart, Under-secretary of State for Health, speaking at a conference at the end of February, said: "The attitude that the benefits of science, medicine or research are somehow self-evident regardless of the wishes of patients or their families is no longer tenable. The NHS cannot continue to work with information behind closed doors. We need to be clear on this", she added, "no change is not an option."⁶

The Government has undertaken, in subsection 9, to consult with representative bodies of those likely to be affected by the regulations. There are very recent signs that this is being put into effect immediately. ’Shooting first, then talking about it afterwards’, however, is another indicator of crisis management.

One area yet to be considered in the frenzy to get this clause enacted as best as time allows is how, if at all, use of the powers of c68(4c) could interact with strategies being implemented to permit freer sharing of patient-care information not only within the NHS but also between public service organisations. What other conflicts will come to light in future that could be solved by the precedents offered in subsection 4c? What information-security loopholes could be opened?

Unfortunately, history shows that reserve powers are frequently invoked in situations far outside those envisaged and described during parliamentary debates. Serious crime translates into inconvenient crime and reserve powers become routine powers. The First Data Protection Principle requires that the obtaining and processing of personal data should be fair and lawful: to allow subsection 4c to become law legitimises virtually anything!

Then there is the genetic-information aspect in research. Epidemiological research has helped to show genetic predisposition to certain cancers. Which safeguards to misuses of cancer-registry databases linked to genetic information databases might be undermined by use of the proposed powers? Diabetes research is another obvious area of relevance.

It seems extraordinary that there is no other means, besides by-passing one law with another, for giving the disease-registry community more time in which to get their data-gathering processes redesigned to accommodate informed consent from data subjects. Does it truly justify introducing a new power over the processing of confidential patient information whereby it " … shall be taken to be lawfully done despite any obligation of confidence owed [by the data processor] in respect of it."?¹

One’s faith in the national characteristic of muddling through to an honourable and democratic outcome is likely to be tested when it comes to fielding the consequences of such hastily introduced legislation.

Another concern is that in the rush to change legislation in order to progress modernisation, which is happening in several sectors simultaneously, government actions lose co-ordination. The storage and use of DNA information 'voluntarily' given by suspects in criminal investigations or by donors wishing to be eliminated from investigations provides a recent example.

i) In 1999, the Government decided that while it was desirable to store the DNA samples of those cleared of charges (ie the innocent) in the police's DNA database, it would only do so if the donor consented. Its decision was published in Proposals for Revising Legislative Measures on Fingerprints, Footprints and DNA samples, in which it stated that the minimum safeguard would be the donor's right to withdraw consent at any time.

ii) Last year the Government set up the Human Genetics Commission (HGC) with a brief to consult the public and research how genetic information might best be handled and used and, then, to advise government ministers. (HGC voiced its concerns about the expansion of the police DNA database, last year, and in its most recent consultation exercise, Whose Hands on Your Genes?, it says "... the fact that failure to consent [to giving a sample] could invoke police suspicion challenges the notion that consent is truly voluntary".)

iii) As one of its consultation exercises, the HGC commissioned MORI to do a poll, the results of which were published last month. To the question: should the DNA samples of acquitted/innocent donors/suspects be kept on the police database?, 48% said no, 46% said yes and 6% didn't know. In other words, no clear opinion emerged.⁷

Yet the Government has proposed, in clause 84 of the Criminal Justice and Police Bill — in advance of the HGC’s recommendations to ministers on the use of genetic information for policing purposes, ignoring the findings of the MORI poll, and seemingly oblivious of it own 1999 decision on the matter — to abolish the donors’ last safeguard.⁸

This illustrates the unreliability of government assurances and, in this instance, provides strong reasons for people to fear entrusting their DNA information to government organisations.

A trend by accident or design?

Add this example of proposed anti-privacy legislation to others of recent times.⁹ The question begs to be asked: is this trend accidental or deliberate? If it is accidental, should 4c be added to the body of evidence? If it is deliberate, isn't it time the public had a say in such a fundamental issue? Taxation by stealth can be lived with, privacy erosion by stealth is another matter.

Climatic factors

A further worry concerns the initiation of any new medical or genetic databases in a seemingly schizoid climate, where on the one hand government passes pro-privacy legislation and on the other proposes/enacts countermeasures, at a time when neither confidentiality nor data security can be guaranteed with the use of ICTs (information and communications technology). Although a Department of Health spokesperson has said that no new databases would be expected to call on the powers of c68(4c), scepticism sees those raring to set up new research databases arguing that they can't wait for new processes and usable PETs (privacy-enhancing technologies) to appear, and if established registries, etc can have 'transitional' exemptions why can't they. There are strong economic and scientific reasons for setting up, and/or linking to, medical-genetic databases sooner rather than later.

If it is relatively easy for a very small sector of society to persuade government to consider riding roughshod over the sacrosanct — ie medical confidentiality — what else can a strong lobbying body ask for, without either openly justifying its need or consulting with others?

We live in a world where history repeats itself, discrimination is widely practised, money speaks louder than morals, information in databases is insecure, and zealots and the power-hungry cut through opposition. Will our descendants come to curse the time our leaders gave in to the pleas of fewer than 100 scientists to grant their work transitional respite from principles and procedures articulated in laws enacted to protect the autonomy and privacy of some 58 million individuals?

Irreparable damage to the relationship of trust between clinicians and their patients is very likely if c68(4c) is allowed to proceed, particularly in the wake of the protest it has ignited. Even to contemplate trading such a permanent loss for a temporary gain seems quite unbalanced.

References

1. UK government. Health and Social Care Bill. Clause 68: Control of patient information. http://www.publications.parliament.uk/pa

2. Anonymous. Cancer registries say informed consent is unworkable. Br J Healthcare Comput Info Manage 2001; 18(2): 11 [News]

3. Anderson R, Hanka R, and Hassey A. Clause 67, medical research and privacy: the options for the NHS. March 2001. http://www.cl.cam.ac.uk/ftp/users/rja14/hcbillc67.pdf

4. Dyer C. Bill gives government power to breach patient confidentiality. BMJ 2001; 322: 256 [News]. Also at http://www.bmj.com

5. Health Minister Lord Philip Hunt welcomes new framework to ensure high quality health and social care research. Department of Health press release 2001/0110 (1 March)

6. Anonymous. Information governance to protect patient-NHS relationship. Br J Healthcare Comput Info Manage 2001; 18(3); 2 [News]

7. Human Genetics Commission. Public attitudes to human genetic information. London. March 2001. Also at http://www.hgc.gov.uk

8. Anonymous. No withdrawal of consent for police DNA database. Br J Healthcare Comput Info Manage 2001; 18(3): 6 (News)

9. Cerberus. Transparency: the missing safeguard in clause 67 of the Health and Social Care Bill 2001. Br J Healthcare Comput Info Manage 2001; 18(2): 16. Also at http://www.gorjuss.com/medicalprivacy/

Note: Clause 68 of the Health and Social Care Bill appeared first as clause 59. New clauses were added the Bill, in its passage of through the Parliamentary stages that caused renumbering — via c62 and 65 to its number at the time of writing, which is 68.

Protest against the clause’s powers and proposals came from several sectors of the healthcare and healthcare informatics communities. Many of the anti-clause 68 arguments have been collected and published at http://www.gorjuss.com/medicalprivacy/