• Regulation
  • Developing mHealth regulation

    The EU has released its green paper on mHealth. It has extensive proposals on regulation. eHealth Law & Policy will be hosting an hour-long webinar on the recent and future developments of the proposed mHealth regulations. Law & Policy is a monthly journal that providesanalysis of global legal and regulatory developments. The webinar is scheduled for Tuesday 16 September at 3pm UK summer time, and will provide insights from legal and regulatory experts.

    Anyone can join the call. As mHealth is set to expand in Africa, this is a great opportunity for African countries to join the discussion and learn from the experiences of EU member countries.

  • eHealth regulation continues its uphill march

    Sisyphus, a King of ancient Corinth, was, according to Greek mythology, condemned to rolling a huge boulder up a hill. When he reached the top, the boulder rolled back to the bottom, so he had to start again. eHealth regulators might feel some sympathy for him. In the USA, three federal agencies have to set out their plans for regulating eHealth. They have until January 2014 to finish it.

    The National Journal reports that the Food and Drug Administration Safety and Innovation Act (FDASIA) requires three agencies to complete the task. The Food and Drug Agency (FDA), the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) have to publish their report for “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT including mobile medical applications that promotes innovation, protects patient safety and avoids regulatory duplication.”

    The three agencies have set up the FDASIA Work Group. It operates under ONC’s Health IT Policy Committee to identify the risks to patient safety from eHealth.

    The FDA’s recent guidance released in September 2013, left “some questions unanswered.” Nor does it deal with all eHealth. EHRs are an example. In addition, the agency has not yet decided how to regulate software that helps physicians make health care treatment decisions. Another challenge is ensuring that new regulations encourage innovation.

    African countries can learn some very valuable lessons from the USA’s experiences. They include:

    Balance the eHealth regulation with limited resources available eHealth regulation is a continuous task, not a single solution at a point in time It is complex, and balancing control with encouraging innovation is always a challenge Be explicit and open about the eHealth regulation priorities being developed, so which ones are not Use one agency as the eHealth regulator, and make it responsible for engaging all stakeholders Empower the eHealth regulator the responsibility for compliance, so have immediate feedback on the appropriateness of eHealth regulations.

    eHealth News Africa will be monitoring developments in the USA and looking for more lessons for Africa.

  • eHealth regulation in Africa: what happens next?

    Like all good projects, they reach the end. The European Space Agency’s (ESA) eHealth regulation study for sub-Saharan countries has now formally ended. Greenfield Management Solutions (GMS), the lead company for the study, has continued to develop and focus the findings for African countries to adopt more easily. GMS is also expanding the model to cover all African countries and other good practice countries globally.

    Workshops with ten African countries revealed three main initiatives:

    maintain and expand the good practices regulation data   add the African countries not included in the ESA study   develop guidelines for countries to adopt as part of their roadmaps.

    African eHealth NGO tinTree is dealing with these, with most of the emphasis on maintaining the survey data, ensuring all African countries are included, expanding good practice country examples and producing eHealth regulation guidelines. Relationships in countries and regional bodies such as RECs are being engaged in the process.

    eHealth News Africa has reported on the study, and will follow tinTree’s next steps so African countries can keep up to date.

  • Some regulation breaches are daft but serious

    Local reports of bad practices by eHealth users show that data breaches are simple to avoid, and can have dire consequences. iHealthBeat, a USA eHealth news digest, reports that an emergency department employee posted on Facebook a photograph of a screen on her computer, and  accidentally showed a patient’s name, address and social security number. Even though the hospital removed the photograph within 30 minutes, criminals used the data to steal the patient’s identity. The patient has filed a police report after the State’s Department of Economic Security notified her that someone had used her personal information to apply for food stamps.

    There are three important lessons for African countries:

    Some breaches are elementary failures, and can lead to serious consequences Train staff to high levels of knowledge and performance about eHealth security and regulation If a breach occurs, notify effected patients immediately, or the consequences may escalate.
  • mHealth regulation from the USA soon?

    There is always more to do to regulate eHealth and mHealth. After the USA’s Food and Drug Agency (FDA) finalised it regulation guidance for mobile health applications in September, iHealthBeat, a USA online eHealth news digest, reports that Congressman Marsha Blackburn will introduce a bill on mobile health application regulations in the next two weeks.

    eHealth News Africa reported the FDA’s mobile regulations in September. They focused on applications:

    Used as accessories to regulated medical devices, such as those to make diagnoses by viewing medical images on smartphones or tablets Transforming mobile devices into regulated medical devices, such as when smartphones are electrocardiography machines.

    Blackburn’s bill has different goals. She said that it will, “protect consumers from the high-risk technologies” and allow lower-risk technologies to “continue to be innovated upon without being caught in that massive web of expense and time that is the FDA approval process.”She added that the bill would “encourage the development of new technologies to improve health.”

    Hillicon Valley, a technology blog in The Hill, says the FDA is damaging the telecommunications industry and crowding out private investment. It quotes Blackburn saying that the FDA “is fixated on growing its jurisdictional footprint and expanding its influence in other areas.” This sounds like the challenging issues of adopting regulation that stimulates investment, not stifle it.

    Any changes from this initiative could expand eHealth regulation good practices that African countries need to know about for their own emerging eHealth regulation initiatives. eHealth News Africa is monitoring progress in the USA.

  • USA's FDA releases its final mobile apps regulations

    At last, the guidance is out. On 25 September 2013, the USA’s Food and Drug Administration (FDA) published is guidance on mobile medical applications. It is similar to its draft guidance released on 21 July.

    It is a collaborative effort by the USA’s. Department of Health and Human Services Food and Drug Administration, the Center for Devices and Radiological Health, part of the FDA responsible for protecting and promoting the public health, and the Center for Biologics Evaluation and Research, part of the FDA that regulates biological products for human use.

    For African countries actively pursuing eHealth regulation, the document is an extremely valuable source of initiatives and ideas. Before adopting or modifying any of these, countries must have their regulatory processes, organizations and resources in place.

    Acfee is planning to add some of these new regulations to its Reference Regulation Model (RRM) as another global benchmark for African countries to use.

  • eHealth regulation workshops in sub-Saharan Africa

    Greenfield and partner Jembi  hosted two eHealth Regulation Workshops in Botswana and Ghana on behalf of the European Space Agency (ESA).

    The focus was eHealth Regulation in sub-Saharan Africa and ESA’s (eHSA) Programme.

    TinTree associates that supported the initiative include Dr Ousmane Ly (Mali), Dr Peter Nyasulu (Malawi), Tom Jones (UK) and Prof Chris Seebregts, Lesley Dobson and Dr Sean Broomhead (South Africa).

    Most SSA countries have several eHealth initiatives underway, and eHealth regulatory aspects are beginning to receive attention. Workshop participants set priorities to expand their action plans for eHealth regulation, including components such as the regulations and regulatory bodies needed to set out on a development path to support a fertile environment for eHealth services.

    Participants shared insights and drew knowledge from one another’s African experience – strengthening eHealth for Africa.

  • New study reveals limited eHealth regulation in sub-Saharan Africa

    Greenfield led consortium concludes eHealth regulation study

    A year-long study on eHealth Regulation in sub-Saharan countries shows that they have much to do to catch up with global good practices. Few have specific regulations for eHealth and rely mostly on telecommunications and data protection laws, but these only provide partial coverage. The average for a sub-Saharan country is less than half of all the eHealth regulations needed. Greenfield, a consultancy based in South Africa, and its partners Jembi Health Systems, Fraunhofer Institute and Thales Alenia España completed the study for the European Space Agency (ESA) during May.

    “Africans use eHealth every day to solve healthcare challenges. The time is ripe to strengthen the regulatory environment to move this forward” says epidemiologist, Malawian Peter Nyasulu.

    The study provides a comprehensive review of eHealth regulation in 48 African countries, suggests specific actions needed to implement a complete eHealth regulatory framework and identifies the most promising scenarios for implementing the fertilisation projects in the second phase of the eHSA Programme.

    Study outputs include:

    A Reference Regulatory Model, instantiated with all types of eHealth and 64 eHealth regulatory aspects Details of regulatory environment gaps between five best-practice countries, which have specific eHealth regulations, and the study countries in Africa, which rely primarily on telecommunications, data protection legislation and cyber-security legislation Ten African countries that are shown as ready to develop eHealth regulation using a Regulatory Readiness Index that comprises each countries RRM position, their information society and eHealth maturity, using the International Telecommunications (ITU) information development index and the World Health Organization’s (WHO) eHealth survey, and healthcare spending per head of population Roadmap for the ten ready countries with a five-year horizon, the first two years assigned to developing eHealth regulation processes, organisations and resources and compliance, then expanding specific eHealth regulation from year three. Roadmap for other countries with a five-year horizon with the first four years assigned to developing eHealth regulation processes, organisations, resources and compliance, then expanding specific eHealth regulation from year five as they expand their eHealth initiatives.

    The regulation study concluded with two international eHealth regulation workshops, held in Botswana and Ghana with 10 African countries represented. Key regional stakeholders such as the African Union Commission (AUC), WHO-AFRO, NEPAD-Agency, AfDB and SADC participated in the workshops. These validated study findings and provided the study team with valuable insights into eHealth dynamics, challenges and specific eHealth initiatives in the region, and enabled the countries to start setting their eHealth regulation frameworks in place.

    Project advisory board member Dr Ousmane Ly remarked: “eHealth regulation is critical for all countries. I am here to take key messages home to strengthen our plans in Mali”. This was echoed by participants from many countries, particularly Rwanda, Botswana, Senegal and Ghana.

    A number of countries have begun planning how to include study findings and recommendations in their on-going eHealth development work. Says Greenfield International Relations Advisor Lesley Dobson “Our team will continue supporting these countries’ efforts to embrace eHealth opportunities to strengthen healthcare”.

    Greenfield founder Dr Sean Broomhead echoes this sentiment: “Our work in Africa is far from over. During the next 12 months we will provide extensive support to non-profit TinTree International eHealth to help the NGO support countries and regional bodies such as WHO-AFRO to move eHealth, and its regulation forward.” The eHealth regulation road maps and action plans provide detailed material to support countries’ efforts.

    The study is one of four horizontal studies of the first phase of ESA’s Satellite Enhanced eHealth for sub-Saharan Africa (eHSA) Programme. The other studies deal with governance, interoperability and sustainability.

    For the full summary report click here.

    More information is available from Mrs Shinaaz Bhana, Greenfield General Manager.


    Phone: +27 53 832 2655