Legal uncertainties linger as teleradiology expands

August 18, 2008

Telemedicine has developed considerably over the past four or five years, turning from a much-debated theory into a practical reality. E-prescribing, telemonitoring, and teleradiology are becoming increasingly commonplace, and further growth in these and other areas is likely.

Telemedicine has developed considerably over the past four or five years, turning from a much-debated theory into a practical reality. E-prescribing, telemonitoring, and teleradiology are becoming increasingly commonplace, and further growth in these and other areas is likely.

The expansion of telemedicine has been so rapid that medical regulation is struggling to catch up. While the absence of regulation has not necessarily caused any problems yet, as more players enter the field the potential for medicolegal difficulties will only increase. Intuition suggests that the pioneers in the field are likely to be above-average in terms of competence and will set high standards of practice. But as time goes on and the market becomes more competitive, then companies with lower standards may appear.

It is not difficult to see how problems could arise. If a doctor providing a service for a patient is physically present in the same country, any disputes can be dealt with under that country's regulations and legislation. When the service is provided remotely by practitioners in another country who are bound by different regulations, it may become much more difficult to hold individual doctors to task for their actions and seek redress for patients.

The trend toward telemedicine is being driven by economics. In this era of cost containment healthcare, providers will undoubtedly be drawn to deals with contractors who will take a lower wage and make their own provisions for health insurance, sick pay, and pensions. Fee-per-item reimbursement could lead some teleradiologists to report at a rate that is too fast for a considered response.

The uptake of telemedicine solutions has been greatest in English-speaking regions, but no country will be immune to the outsourcing trend. The widespread availability of translation packages is removing language barriers. Every European country will soon be a potential business opportunity for telemedicine entrepreneurs. The manner in which healthcare services are delivered three to five years from now is likely to be very different from the situation today.

The provision of telemedicine within the European Union is guided by two essential tenets. EU citizens, doctors and healthcare providers included, are free to move about for work within the member states. At the same time, there is a requirement that patient safety be upheld. So if a radiologist from the U.K. wants to start practicing in France, for example, he or she will typically register with the appropriate French medical authority.

This practice has been applied to teleradiology services supplied by a company based in one EU country to a healthcare provider in another member state. Such arrangements are not enshrined in European law, though, so who is to say they will continue? Also, in countries where the state does not have a monopoly over healthcare provision, who will police the private healthcare providers? When profit is a major factor in healthcare delivery, cut-price outsourcing deals from companies with less than rigorous quality assurance policies could be difficult to resist.

Consider the 2007 Portugal Agreement. Under this nonbinding agreement, health regulators across the EU undertake to share information about practitioners who have either been barred from medical practice or had their practice restricted in some way. This has obvious, positive implications for teleradiology QA.

But it is not a law, and there is no obligation on member states to comply. It is simply an informal voluntary agreement. Also, the Portugal Agreement applies only to the EU. Teleradiology companies operating from the U.S., Australia, India, or China, for example, will not be covered.

Another issue predicted to emerge is the practice of "ghost reporting," whereby the contracted radiologist merely approves a report written by either a different radiologist or a radiographer. The report could even have been written in one language and then translated by computer software into a second language. The contracted radiologist may simply be checking that the report makes sense linguistically, rather than comparing the diagnosis against the original images.

No instance of ghost reporting has been discovered to date. That is not to say that it isn't being practiced or that it won't be in the future. One way to protect the validity of reports could be to implement a system of "electronic fingerprinting." In practice, however, there is nothing to prevent contracted radiologists from passing their login details to a junior colleague.

REGULATORY CHALLENGES

The idea of EU-wide regulation of telemedicine will not necessarily be welcomed by all stakeholders. Researchers and entrepreneurs who are passionate about technological advances that could have a real, clinical benefit may regard regulation as little more than a barrier to progress. Companies that have invested in telemedicine projects are also unlikely to welcome anything that appears to hamper commercial opportunity. Private healthcare providers may be unwilling to sign on to stricter controls on their business.

Producing EU-wide legislation could also be a lengthy process. The EU now comprises 27 member states, each of which has a different form of healthcare regulation. Some countries have regional tiers of regulation as well as national ones. Some operate with a clear demarcation between the state and the healthcare regulators, while in others the boundaries are more blurred. All of these issues complicate the process of consensus on EU-wide regulation.

Then there is the question of implementation. The European Working Time Directive, passed 10 years ago, has yet to be fully enforced. Even if a directive on telemedicine were passed today, it would not change practice overnight. Member states would still have to incorporate it into national law, which could take years.

Getting global agreement on standards for teleradiology could be even trickier. The International Radiology Quality Network could have an important role here. The IRQN includes representatives from the American College of Radiology, European Society of Radiology, U.K. Royal College of Radiologists, Japan Radiological Society, and Royal Australian and New Zealand College of Radiologists. Liaison occurs with the World Health Organization.

Visit

www.irqn.net/content/standards.shtml

for online copy of the IRQN's Top 10 Principles of International Teleradiology.

Achieving worldwide consensus is going to be a considerable undertaking, given the vast divergence among healthcare systems, the differing roles of the state and private insurers, and links with corporate investors. Going for an EU-wide solution first may be more achievable.

In mid-July, the European Court of Human Rights ruled that the Government of Finland had breached Article 8 of the European Convention of Human Rights [the individual's right to privacy] by failing to take positive action to protect the plaintiff's patient confidentiality. It was inadequate for the hospital to only know the identities of the last five people to access her healthcare data. The Court instructed the Government of Finland to financially compensate the plaintiff, a nurse.

PRESSING AHEAD

The current market leaders, in all likelihood good-quality teleradiology providers, have much to gain from regulation. They recognize that in the not- too-distant future they may face real threats from "cowboys," companies that may cut corners to make a quick profit.

So what is to be done? This is not a situation where a nicely worded document from the ESR, the European Union of Medical Specialists, or a national radiological society to the relevant European Commissioner is going to be sufficient. Professional societies should certainly lobby Brussels. But this alone will not be enough, and they may be accused of having a vested interest in restricting practices.

The necessary major change in regulation, a philosophical change, is going to take real pressure to achieve. This is where patients' organizations have such an important role. It is these groups that have true moral authority.

Radiological societies in each member state should forge links with patients' organizations. They should encourage the patients' representatives to lobby at a national and EU level. There will be lots of different perspectives from patients, but we should help coordinate their advocacy to demand equivalent regulation for all doctors, all healthcare providers, wherever they may be based, who provide care for European patients.

The impetus for regulation will probably accelerate once problems start to emerge. Well-publicized scandals involving patients are very difficult to ignore. Instances of malpractice and fraudulent practice will most likely appear first in the world of e-prescribing, where it is relatively easy and cheap to set up business and to reach patients directly. However, problems in just one area of telemedicine may well be sufficient to convince politicians of the need to regulate across the board.

A telemedicine scandal involving healthcare delivery from one EU country to another would be a major embarrassment to politicians in Brussels. For this reason alone, it is in the interests of the European Commission to introduce telemedicine regulation and legislation as soon as possible.

I am confident that regulation will catch up with telemedicine, though it might take a while. The Portugal Agreement is scheduled to be in force by the end of 2009. That is not a particularly ambitious timescale, and it could well be accelerated.

It is also important to remember that telemedicine regulation is just like any other form of regulation. It needs to evolve with time. The first telemedicine directive from the EU isn't going to sort everything out once and for all.

DR. FITZGERALD is a consultant radiologist at the Royal Wolverhampton Hospitals NHS Trust in the U.K.

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