Out-Law News 3 min. read

Regulatory barriers could restrict potential benefits of m-health in Brazil and Mexico, says GSMA


A telecoms industry body has warned that regulatory barriers could prevent mobile health (m-health) solutions from delivering more widespread healthcare and cost-savings in Brazil and Mexico.

The Global System for Mobiles Association (GSMA) said that regulatory, economic, structural and technological barriers all must be overcome if m-health is to deliver as significant a change to healthcare in the two countries as it has said it has the potential to do. It said the widespread adoption of m-health could enable healthcare to be delivered to millions of patients who otherwise could not afford treatment and that it could also enable healthcare providers to make cost-savings over the way they deliver services.

The GSMA is a trade body that represents mobile operators across the world.

The term 'm-health' broadly refers to the practice of using mobile IT to deliver services in the health sector. The applications vary widely, from engaging in patient records management through tablet devices, to recording patients' heart rate, glucose or blood oxygen levels remotely through applications available on smartphones, to providing medical interventions and diagnostics.

The GSMA has said that m-health solutions could deliver healthcare to an additional 28.4 million people in Brazil and 15.5m people in Mexico by 2017 and that healthcare providers in the countries could between them save $17.9 billion in the cost of delivering healthcare services.

The GSMA said that the widespread rollout of m-health in Brazil and Mexico could save almost 16,000 lives and add to the left expectancy in both countries. In addition, m-health could save doctors 14.6m working days by offering improved methods of preventing, diagnosing and treating illnesses, it said.

However, GSMA said that regulatory barriers exist that could prevent the full benefits of m-health being realised in Brazil and Mexico, as well as the adoption of m-health solutions in other countries in Latin America.

"Policy and regulatory approaches are not yet developed to support m-health solutions reaching patients and healthcare professionals quickly and effectively," GSMA said. "The absence of clear regulatory frameworks that guide the development and deployment of these services is slowing down adoption."

Technology law specialist Matthew Godfrey-Faussett of Pinsent Masons, the law firm behind Out-Law.com, recently said that inconsistent regulation across different EU countries may be hindering innovations in electronic health (e-health), and in particular, m-health. http://www.out-law.com/en/articles/2013/may/fragmented-legal-frameworks-hindering-m-health-innovations-in-eu-says-expert/ Uncertainty still persists within the EU over "compliance with medical device regulations; data security and data protection compliance; and liability for medical negligence", for example, he said.

Alison Ross Eckford of Pinsent Masons, also recently explained more specifically some of the data protection considerations that have to be made around m-health http://www.out-law.com/en/articles/2013/may/savings-possible-through-mhealth-projects-but-health-bodies-must-consider-privacy-implications-says-expert-/ in a UK context.

"The Data Protection Act demands that organisations treat individuals' sensitive personal data with utmost privacy as this data attracts specific protection under the Act, and in addition, patient confidentiality must be maintained at all times," Ross Eckford said. "In effect this means that mobile devices used to store, access or transmit patient data must be secure and not capable of being accessed by unauthorised individuals."

"Data transmissions should also be encrypted and secure to prevent data being intercepted, and, in accordance with the Act, the information should only be processed for specified purposes, such as to input data about a patient onto a server containing their medical records or to send a patient a text reminder about hospital appointments," she added.

GSMA said that there are additional barriers other than regulatory ones that have to be overcome in Brazil and Mexico if potential benefits of m-health are to be realised. These barriers include the fact that the healthcare systems in Brazil and Mexico currently "incentivise individual treatments and medical prescriptions rather than focus on preventative and continuous care". It said that "clinical evidence" is needed to convince healthcare providers, governments and insurers to get behind the m-health initiative.

In addition, GSMA said that barriers related to how the healthcare systems in Brazil and Mexico are structured must also be overcome. Current systems restrict information sharing and process alignment thus "preventing m-health from scaling effectively", it said. The lack of interoperable systems and standards used for delivering healthcare via m-health solutions are also barriers that limit m-health from being delivered other than on local levels, GSMA added.

"M-health can help countries like Brazil and Mexico tackle the significant challenge of providing universal healthcare to a large, dispersed population," Jeanine Vos, executive director of m-health at the GSMA said. "The pressures on healthcare resources and the increasing burden of chronic diseases make it key to deploy innovative and cost-effective solutions."

"M-health will enhance the reach, efficiency of spend and effectiveness of care to provide better quality health services to more people. Therefore it is critical that governments and regulators work with healthcare providers and mobile operators to drive m-health adoption," Vos added.

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