1. Individuals have a right to apply for access to health information held about them and, in some cases, information held about other people. NHS organisations should ensure they have adequate procedures in place to enable patients to exercise this right.
2. The following guidance assists NHS organisations in England, through the process of dealing with an access request in accordance with the relevant legislation and any subsequent considerations. This supersedes previous guidance issued by the Department of Health in July 2002 and June 2003 titled ‘Access to Health Records’.
3. The main legislative measures that give rights of access to health records include:
   • The Data Protection Act 1998 – rights for living individuals to access their own records. The right can also be exercised by an authorised representative on the individual’s behalf.
   • The Access to Health Records Act 1990 – rights of access to deceased patient health records by specified persons.
   • The Medical Reports Act 1988 – right for individuals to have access to reports, relating to themselves, provided by medical practitioners for employment or insurance purposes.

Indeed, the EMA logically thinks that before we can communicate well we need to reach an agreed definition on what we mean by benefits and risks and determine the best methodology for measuring and describing them.

Research among 42 assessors of drugs showed that there was no agreed definition of benefits and risks but rather multiple definitions. There was no agreed systematic approach, but there was agreement that it was difficult to define and measure benefits and risks.

Should definitions be qualitative, quantitative, or both? Should there be explicit criteria for both benefits and risks? How can patients’ values best be incorporated? How might definitions relate to the severity of the conditions being treated? Patients will accept much more risk in treatments for serious, life threatening illnesses. How can definitions deal with the gap between efficacy (as measured in clinical trials) and effectiveness (what happens in the real world)? And what about drugs being used off label, when there may be risks but no benefits? What is the best way to acknowledge uncertainties? How can doctors explain to patients that only 20% of them may benefit from a treatment and that we have no way of knowing whether any particular patient is in the 20% or the 80%? How can we best describe the huge uncertainties around the benefits and risks in the many patients who have multiple comorbidities?

The EMA is tackling these questions with a series of activities and hopes to have some answers within about 18 months. But what might be the role of drug companies in communicating benefits and risks? This question was discussed at a meeting I attended at the Royal Society last week.

Drug companies are understandably perplexed about their role in communication in Europe. They know more about their drugs than anybody else, but they are not allowed to communicate with patients—even if a patient contacts them with a specific question. Politicians in Europe are unyielding in their refusal to allow drug companies to communicate with patients—fearing bias or inflation of their drug budgets.

A particularly tricky issue arises over periodic safety update reports (PSURs), which drug companies are required to present to the EMA. These may be huge documents and give detailed, patient level information of new reports they have received on adverse drug reactions and any other new information that bears on the safety of their product. Most doctors and patients don’t know of the existence of these PSURs, but some groups have found out about them and want to know more.

The motivation to know more might be either a hunger from patients for all relevant information or a fear that something is being hidden. Various groups in Europe have asked to see these reports under freedom of information acts, and some redacted versions have appeared on websites in the Netherlands. (We in Britain learnt the word “redacted” through the scandal of MPs’ expenses: it means that some information, in this case patient details, is blacked out.)

As they stand these PSRUs are not good for communicating benefits and risks for patients, not least in that they concentrate on risks and say little about benefits. But could they be made useful? This remains an open question, but most people at the meeting thought that better ways could be found to communicate benefits and risks—particularly after the EMA has completed its work on definitions.

There were disagreements at the meeting, but everybody seemed to agree that many medicines are not used rationally and that it’s in the interests of everybody—patients, clinicians, regulatory authorities, health care funders, and drug companies—that they come to be used more rationally. Better ways of communicating the benefits and risks of medicine will be one way to help achieve that aim.

Competing interest: The meeting was funded by Roche, but I received no fee or expenses. I did, however, have two cups of coffee, two cups of tea, and a tasty lunch, for which I thank Roche. If I was an employee of the US government I wouldn’t have been able to accept the lunch, but I can’t say I feel corrupted.

MEND (Mind, Exercise, Nutrition, Do it!) is a social enterprise that is research driven and has developed a family and community based treatment for childhood obesity. The treatment has been shown in a randomised trail to be published in Obesity next year to reduce waist circumference and body mass index and to increase cardiovascular fitness, physical activity, and self esteem.

The treatment comprises advice on behaviour change, nutrition, and physical activity. There are 18 two hour sessions delivered over two weeks by two trained leaders and an assistant to groups of 8-15 children with their parents, carers, and siblings. The sessions happen in schools or sports centres, and there are eight on behavioural change, eight on nutritional advice, and 16 with physical activity. The treatment is highly standardised with training for the leaders, theory and exercise manuals, children’s handouts, programme resources, and teaching aids. There is detailed guidance on how to run each session.

Childhood obesity is concentrated in poorer children, and MEND is committed to promoting health equity. Of the children in the trial half were from ethnic minorities and two thirds came from families where the parent or parents were unemployed or doing manual jobs.

Having found an effective intervention MEND has had to find a way to scale it up—and has developed a technology platform called OMMS (Operations Management Monitoring System). This makes it easy for the programme manager to organise and monitor the programme and for the MEND team to quality assure the programmes and to gather data on all the participants in the programmes. Some 17 people, mostly in India, have been involved in writing the software and running the system.

It’s this scaling up that most public health programmes don’t manage and makes MEND so important. There are now some 350 programmes running across the country—some paid for by primary care trusts and some sponsored. Each extra programme means that the unit cost per programme (total costs divided by number of programmes) goes down, making scaling ever easier. MEND has data on some 12 000 children and have found results similar to those in the randomised trial—and importantly many of the children are still from deprived backgrounds.

Childhood obesity is a global problem, even co-existing in poor countries with undernutrition, and MEND has work underway in Denmark, Australia, and US. The latter two are the “fattest” countries in the world, and the US has 25 million obese children.

Another important challenge for scaling up is to find a scalable business model. That can’t be research grants as research funders are not in the business of implementing the results of the research they fund on a large scale, although perhaps they should be. Depending on sponsorship is fickle, and sponsorship rarely goes on for long. The best model is paying customers, organisations and people who value what you have to offer and will pay you for it. You can then invest your “profit” in improving and expanding what you have to offer—so delighting customers and increasing their number, bringing in more funds, and generating a virtuous circle.

MEND will need to find a sustainable, scalable model because despite its success it has a huge way to go. If 15,000 children in Britain have been treated that leaves 2,985,000 who haven’t—and there are hundreds of millions in the rest of the world.

People living in the big cities have access to the latest medical technology, whereas those living in the countryside are served by a “village doctor” (many of them once the famous barefoot doctors) with limited training. So far most health research has been conducted in large hospitals in the cities, but a new programme—the China Rural Health Initiative—plans to build a platform for research in rural areas  Last week in Beijing I heard the plans for the initiative.

The China Rural Health Initiative is the flagship programme of the China International Center for Chronic Disease Prevention, which is based at the George Institute China, with Peking University Health Science Center its lead domestic partner. There are also five partners from five of the provinces closest to Beijing, which together have about 190 million inhabitants, and six international partners, including the George Institute in Sydney, Duke University, and Imperial College.

One of the first studies to be conducted will be a cluster randomised trial of training the village doctors and providing community health education to prevent heart disease and stroke. People in Northern China use huge amounts of salt and consequently have high levels of hypertension and stroke. Many people have a daily consumption of 12 g or even more (when WHO recommends no more than 5 g and many think it should be 2.5 g), and poorer people use more salt.

The village doctors will receive training in a simple, low cost, evidence based package for high risk patients that includes regular blood pressure tests, free medication, and salt reduction and potentially substitution. The doctors will also be given a health education kit and incentivised to practice prevention. The primary outcome measure of the trial will be the proportion of high risk people treated with at least one drug, and secondary outcomes will be blood pressure and the control rate of hypertension.

There is also a provisional plan to at the same time conduct a trial of community based education on reducing salt consumption. Twenty five townships with between 18 000 and 26 000 inhabitants would receive both interventions (training of village doctors and community education), 25 neither, and 25 each one or the other. The hope is that this will lead to a package that could introduced across rural China.

A third possible study if funding can be found will be a randomised trial of salt substitution with high risk individuals. Families with high risk individuals would be randomised to receive free salt substitute (containing 65% salt, 25% potassium chloride, which lowers blood pressure, and 10% magnesium sulphate) or to the control group. A pilot study has already shown that salt substitution can lower blood pressure by 5 mg Hg (about the same as one drug), but the proposed trial would look for a reduction in stroke, heart attack, and death. Because of the known reduction in blood pressure there is every reason to expect a reduction in events and deaths, but the investigators judge that such a trial would lead to a change in policy in China and beyond.

It’s possible to do a trial like this in rural China because most salt is added by people when cooking, whereas people in Chinese cities and the developed world receive most of their salt through processed foods.

A fourth possible study, again dependent on funding, would try to validate a method of verbal autopsy. Physical autopsy is not possible in most developing countries, and the data for the global burden of disease are based on doubtful evidence. The study would compare the diagnosis reached in those who die in hospital (the best “gold standard” available) with a verbal autopsy, a series of questions, used with carers one to three months after death. This would be done for the top 20 to 40 causes of death, and if the verbal autopsy proves reliable then a later study would quantify the cause of death across communities.

The great attraction of establishing a reliable platform for research is that other studies can be conducted without the difficulties and cost of developing a platform, and already there is interest in studying biomarkers, interventions to prevent progression of chronic kidney disease (which is known to be common in rural China), and telemonitoring to speed treatment of patients with heart attacks. Remarkably, another possible study is a randomised trial of conservative versus surgical treatment of hip fracture; this might be possible in rural China because it seems that many patients are treated conservatively.

No doubt many other studies will be proposed, and the hope must be that the result is not simply lots of publications but real improvements for the vulnerable, poor people in rural China.

Let’s begin with Freddie Ayer, the Oxford logical positivist whom as a student I saw lecture in Edinburgh. The story of his encounter with Mike Tyson the New York party of an underwear designer is well known, but I’d not heard it. Tyson had begun to assault Naomi Campbell, and Ayer confronted him. “Do you know who the fuck I am?” asked Tyson. “I’m the heavyweight champion of the world.” “And I,” replied Ayer, “am the former Wykeham Professor of Logic. We are both eminent in our fields; I suggest we talk about this like rational men.”

In the mid-70s Ayer was asked what was the most important defect in his hugely important book Language, Truth, and Logic. “Well,” answered Ayer, “I suppose the most important defect was that nearly all of it was false.”

Later Ayer had a near death experience after choking on a piece of salmon, and his wife said of him “Freddie has got so much nicer since he died.”

Schopenhauer was arguably the most pessimistic philosopher ever, but he had a way with words that (perhaps because of my warped sense of humour) makes me laugh. “Life is an expiation of the crime of being born…We begin in the madness of carnal desire and the transport of voluptuousness, we end in the dissolution of all our parts and the musty smell of corpses.” A notorious misogynist he wrote: “Marriage means to grasp blindfold into a sack hoping to find an eel in an assembly of snakes.”

Wittgenstein is not thought to be a bundle of laughs, but he had his moments. The last months of his life were spent working intensely and living with Dr and Mrs Bevan. He would go to the pub every night with Mrs Bevan, and on his birthday she wished him “many happy returns.” Staring back at her, he said “There will be no returns.” He lived a life, writes Critchley, of “austerity, fighting inner torment, a deeply troubled relation to sexuality, and utter ethical earnestness.” No wonder his jokes were so deadpan.

Some of the same epithet might be applied to Oscar Wilde, a philosopher of a milder type, whose last words were “Either that wallpaper goes or I do.”

The long term vision of the social entrepreneurs at the day is that the internet can make all public services, including the NHS, police, and local government, more responsive, more bottom up than top down. Patients will not be seen simply as needy recipients of care but people who through sharing their stories and experiences can help others.

Denise Stevens, founder of Enabled by Design, described how she’s begun to make this vision a reality. She has multiple sclerosis and found that the living aids that she was given for her home were ugly and depressing and made her home feel like a hospital. Surely, she thought, it doesn’t have to be like this. She found mainstream products that looked a lot better and would serve her needs just as well as those supplied by the NHS, and then she wondered what she could do to make things better for others. The website she founded has her blog, loves and hates, product reviews, and an ideas factory. Other people can find their way to better products, but her longer term aim is to stimulate innovation and good design in an area that hasn’t had it for decades: aids now look very like those from the 1970s.

Tom Loosemore, the head of Channel Four’s Innovation for the Public Fund and formerly head of broadband at the BBC, is getting impatient with the speed of progress. After 10 year’s of thought he has reached the radical conclusion, unpopular with many, that governments should get out of websites. NHS Choices, for example, should be canned. The problems with government websites is that they are stuck firmly in the past, dampen innovation, are terrible value for money, and stop government truly “listening” because moderation of websites is in the end censorship.

Instead of building websites government should make data available for other organisations—whether for profit or not for profit—to build into websites with contractual requirements to keep the websites up to date and display the brand of whomever produces the data—perhaps the NHS. Similarly governments should pull out of transaction sites and let other organisations build them. This arrangement is common in the United States, and HM Revenue and Customs has begun to make it a reality here, allowing interaction of its system with other systems.

The result of such a development, Loosemore believes, would be an acceleration in innovation, more rapid achievement of the vision of the public becoming cocreators of public services, and dramatically improved value for money. A representative of NHS Choices was less keen but welcomed competition and the existence of Patient Opinion.

From his experience at the BBC, where he closed several community sites, Loosemore also believes that government—and the BBC–should listen not through its own websites but through tapping into the conversations about their services going on all over the web.

The values of Channel 4 written into the act that created it are that it must encourage innovation, inspire change, and “make trouble in the public interest.” These, he argued, are excellent values for those using the internet to improve public services. I agree.

We are getting some nice coverage about the Stelios Award. First to cover is the The Deaf Blog, a blog about the achievements of people with hearing difficulties.

Hard-of-hearing businessman shortlisted for Stelios Entrepreneur Award

Mohammad started Patients Know Best to help himself and ten million other patients with long-term illnesses in the UK. The company allows users to conduct consultations online instead of in-person, with Mohammad communicating with all of his clinicians securely through his work computer.

He says, “Our vision is for a publicly traded company serving ten million patients in the UK, Middle East and USA. By operating in these markets, starting with the UK, we aim to transform the provision of care for patients with long term diseases by giving patients more control. Winning this award would also show that it’s people’s ability – what you can do – and not the disability that matters.”

Sir Stelios said: “I am passionate about encouraging entrepreneurship and working with Leonard Cheshire Disability to set up this award plays a big part in this.

“I would like to congratulate Mohammad for reaching the shortlist of this year’s award, it is not an easy task to be nominated because there was stiff competition.

Sophie Down, Corporate Partnerships Officer, Leonard Cheshire Disability, said: “To be shortlisted Mohammad had to prove that he is dynamic, driven and that his business is destined to be a success.

“Our partnership with Sir Stelios is helping the charity highlight the barriers disabled people face in the workplace and recognise the outstanding achievement of disabled entrepreneurs.”

David Molyneaux from Liverpool said that an alien observing earth for the first time would think that it had only three diseases: AIDS, TB, and malaria. He is one of the “three dinosaurs of neglected tropical diseases (NTDs)” who spoke at the meeting, pointing out that sums that are very small by the standards of AIDS could make a huge difference in alleviating the suffering of the world’s poorest people from schistosomiasis, onchocerciasis, sleeping sickness, elephantiasis, and the other neglected tropical diseases. Some of these diseases can be treated very effectively and cheaply. Deworming people—as animals have long been dewormed—for 60 cents a year could make huge differences to child growth and development and levels of disability.

Neglected tropical diseases have received some funds and had successes with treatment and eradication, but why have they not received the attention and funding of AIDS when much more could be achieved with much less money?

Molyneaux thought that one problem was that most people in rich countries had never heard of these diseases and had no idea of the extent of harm they can cause. Broadcast media are reluctant to make programmes on the diseases because people don’t know what they are—and the pictures of people severely affected by the diseases they judge to be just too horrible. Then health ministers in the affected countries—mostly in SubSaharan Africa—are highly unlikely to get the diseases themselves because they are the diseases of the poorest people living away from the capitals and often away from any health services at all.

The preoccupation with AIDS, TB, and malaria may well be creating harm, argued the Lancet’s Rhona McDonald, a passionate advocate for global health and social justice. She described first hand experience of intense political battles over whether the “vertical programmes” for treating AIDS, TB, and malaria—the “global health initiatives”—had done harm by diverting attention and resources from basic health systems.

Then she emphasised the importance of clean water, sanitation, food security, and human rights. Health is impossible without these basics, and preoccupation with the medical model can be a distraction.

Allyson Pollock from Edinburgh built on this theme, reminding the audience that the huge advances in life expectancy and quality in the developed world in the past 150 years came mainly from public health not from drugs and vaccines. She also emphasized the importance of the collection of routine data on births, deaths, and the like and feared that data on the global burden of disease may be misleading because so many countries do not collect routine data.

If the alien that observed that the earth had only the three diseases of AIDS, TB, and malaria had found its way into the meeting it would have emerged thinking that the earth needed to rebalance its priorities.

Prince Harry was, as most people know, a dissolute youth, hanging out with drunks, pimps, whores, and undesirables with the great Falstaff chief among them. But when his father, Henry IV, dies he turns away from those scoundrels. “I know thee not, old man,” he tells Falstaff: “Presume not that I’m the thing that I was.”

Once he is king Henry needs a mission, a great cause—and that mission is to conquer France not for wealth or for aggrandisement (although we may be skeptical) but for “honour,” something very important in the 15^th century and not well understood in the 21^st (except perhaps by the Mafia).

Janni, a coach to chief executives around the world, is keen to promote what the Greeks called “mythos” as opposed to “logos.” We live in a world where logos—business plans, strategies, and accountants—are dominant, and we must rediscover mythos, the world of myth and imagination. “Imagination,” said Einstein, “is more important than knowledge”: it shows us what can not simply what is.” Studying Henry V allows us to enter the world of imagination and inspiration—“Oh for a Muse of fire, that would ascend the brightest heaven of invention.”

To be an effective leader you must look into your soul to understand your values and what is most important for you. You need “space to be with yourself,” perhaps through reading, walking, or listening to music. “Unto thine own self be true,” says Shakespeare in Hamlet, and very crucially leaders must examine the overlap between their values and their work. The more overlap the better, and it’s almost impossible for leaders to be effective if there is little overlap. You will be seen to be a fake. (I’ve experienced doing jobs where there was little overlap, and I couldn’t keep going.)

The test of Henry V’s leadership came at Agincourt—in Act IV. His invasion of France had been a failure. Having got bogged down at Harfleur, lost 2000 of 6000 men, and run into winter, Henry and his army are retreating to Calais when they meet the French army, which has 10 times as many men. The French offer Henry a choice: a substantial fine and a safe passage to England or a battle and certain death.

Henry choses a battle, and at 3 in the morning he walks among his troops as they can hear the French already celebrating the next day’s slaughter. He is fearful, but he cannot show it. He must show a brave, fearless face to his troops, whom he calls not colleagues but “brothers, friend, and countrymen.” This, says Janni, shows the importance of “visible leadership,” being there when times are tough and giving your troops what they need.

Next Henry meets privately with Gloucester. To him he can express his fears. Every leader needs a Gloucester, somebody to whom everything can be said—not to advise them but to be there, to listen, and to provide support.

Then Henry is called to a meeting, but first he must prepare himself. He must be alone. “I and my bosom must debate a while.” He must listen to his head and his heart in this “dark night of the soul.”

Another lesson in leadership is the importance of listening to the troops. Henry goes in disguise and joins four ordinary soldiers sat around a fire. They think that they are going to die, that it’s Henry’s fault, and that he will get away while they die. In other words, he can’t be trusted. These are hard things for a leader to hear, but leaders need to know the truth of what their troops are thinking. But they also need to be resilient, recognising that they cannot always be liked.

(At this stage I thought of Gordon Brown, somebody of whom many had such hopes but who has disappointed most. The coming election looks like his Agincourt in that he is facing near certain defeat and a massacre of his troops. Does he know what his troops are thinking? Is his “resilience” to be admired or deplored? Will he manage a St Crispin’s Day speech?)

Next Henry lets it all hang out. In one of the longest soliloquies Shakespeare wrote he expresses all the miseries of being a leader: “We must bear all. O hard condition.” This release is important for leadership.

Finally, Henry launches into his great St Crispian’s Day speech, connecting himself and his troops to his and their core values. He has overheard Westmoreland wishing they had more troops, and this gives him the theme of his speech. He connects troops with their core values not by listing them but by appealing to their imagination, asking them to imagine themselves years from now in a pub reveling in the glory of having been at Agincourt, showing their scars to those who are jealous that they were not there.

“If we are marked to die, we are enow To do our country loss; and if to live The fewer the men, the greater share of honour….He that outlives this day, and comes safe home, Will stand a tip-toe when the day is named, And rouse him at the name of Crispian…From this day to the ending of the world, But we in it shall be remembered; We few, we very happy few, we band of brothers.”

What leader would not love a Shakespeare to write his speech and an Olivier to deliver it for him.

There are two things that surprise most Brits when I tell them about electronic medical records. First is that very little information is shared. This is not out of privacy fears, but just because too little information is in computers, and too few are connected to each other. That is why when you go to your doctor they often have no idea what happened at your previous appointment with another doctor. And second is that the UK, or at least England, is one of the most advanced countries in information sharing. It is perhaps as good as it gets in data connectivity at a large scale.

But it is early days, technology is advancing quickly, and technology gives you choices. So the question to the audience was: what choices would they make in sharing information?

The Bradford crowd were lovely to talk to. Engaged and polite, but also with a wicked sense of humor. Like most other people, they wanted all their clinicians to have access to all their medical notes. However, they struggled with the issue of access by others, and each of them made different choices, for different reasons. And this is the problem with national data sharing. It does not allow personal decisions, something that personal health records platforms, including ours, are designed to handle so well. This why I get so excited about our work and how we can help patients.

The second session was about sharing medical information with researchers and Stephen Whitehead from the New Economics Foundation led the discussion. He is currently managing the Who Sees What? deliberation project on the ways that personal data is used by the NHS. Most people were in favor of sharing data for research, but many felt uncomfortable about payments from and access by pharmaceutical companies, even though they all understood the important contribution the companies make to curing diseases. PatientsLikeMe is interesting because its founders aimed to create a safe environment for patients to share their data with researchers and companies. They key is that the individual patient is in control of the data sharing. It is worth listening to the PKB interview with Dr Paul Wicks from PatientsLikeMe as he discusses these issues.