Government & Policy

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Last week, the House Committee on Health in the Philippines House of Representatives chaired by Rep. Angelina Tan approved a substitute bill seeking to establish the National eHealth Systems and Services that shall deliver health services through cost-effective and secure information and communications technology (ICT). WHY IT MATTERS The landmark measure provides for an organised and structured application of electronic health or "eHealth" integrated in the regular workflow of healthcare facilities. Specifically, it seeks to utilise ICT to deliver health services which has the potential to be profitable, improve quality, change the conditions of practice, and improve access to healthcare, especially in rural and other medically underserved areas. The bill also aims to facilitate the exchange and access to secured personal health information, ensure harmonisation or integration, alignment, and interoperability among various eHealth initiatives, and facilitate inter-agency and inter-sectoral coordination at various levels of governance in both public and private sectors. The measure mandates the Department of Health (DOH) as the lead agency to implement the Act and provides for the creation of an inter-agency and multi-sectoral National eHealth Steering Committee to serve as an executive body of the Philippine eHealth System and Services (PNeHSS). Among the changes approved and introduced in the substitute bill is the provision for public-private partnership of eHealth Services. The bill mandates the DOH to promulgate the rules regarding the participation of the private sector in the provision of eHealth services and solutions, including public-private partnerships and other suitable arrangements. An additional provision on research and development was also introduced and will be accomplished through the formulation of expanded eHealth research priority areas under the National Unified Health Research Agenda (NUHRA) as well as the establishment of knowledge hub and research centers for eHealth that study, among others, capacity building, health technology assessment, knowledge management, standards development, and research utilisation. The approved bill also details violations of the Act and corresponding liabilities and penalties. For instance, the unauthorised processing of personal information shall be penalised by imprisonment ranging from one to three years and a fine of P500,000 to P2 million. The unauthorised processing of sensitive personal information shall be punished by imprisonment of three to six years and P500,000 to P4 million. Other violations include accessing personal information and personal sensitive information due to negligence; improper disposal of personal information and sensitive personal information; procession of personal information and personal sensitive information due to negligence for unauthorised purposes; unauthorised access or intentional breach; concealment of security breaches involving sensitive personal information; malicious disclosure; and unauthorised disclosure. Any person who commits a combination or series of these acts shall be subject to imprisonment ranging from three years to six years and a fine of P1 million to P5 million. THE LARGER TREND According to the official eHealth website by the DOH, two main challenges of the Philippines’ health system are access to health care services, and access to real time information for decision making. 70% of the population living in rural areas are still struggling with no or limited access to quality inpatient and outpatient care services. Delayed access to timely, reliable, accurate, and complete health information contributes to the challenges faced by decision makers. This condition is further exacerbated by various health data coming from disparate systems that use differing formats, lacking harmonisation, and putting additional strain on already compromised data quality. Based on the Philippines eHealth Strategic Framework and Plan 2014-20, the DOH envisions that “By 2020, eHealth will enable widespread access to health care services, health information, and securely share and exchange client’s information in support to a safer, quality health care, more equitable and responsive health system for all the Filipino people by transforming the way information is used to plan, manage, deliver and monitor health services.” With the proposed National eHealth Systems and Services Act approved, there is some progress made in the governance component of the eHealth vision but much of the real work will lie in the establishment of the necessary foundations – infrastructures, standards, rules and protocols for the effective implementation of eHealth services, processes and solutions. ON THE RECORD “The Department of Health welcomes the new version of this Act because the future of health is being designed with eHealth, the use of information communications technology in health,” DOH Assistant Secretary Enrique Tayag said. He also suggested that the measure should more clearly provide that private entities are free to use ICT in their delivery of health services.

Candidates for the role should be able to share electronic health record best practices with DoD, oversee change management and training efforts and monitor budgets, officials say.

Common usability challenges can also contribute to medical errors, the organization said.

In December 2018, Thailand’s Ministry of Commerce announced plans to put medical-related fees, including drugs, supplies and service charges, on the price control list of the government’s central committee on prices of goods and services. On January 9 2019, the plan was approved and the Thai government added medicine, medical supplies and medical services to its price control lists, which was announced by Minister of Commerce Sontirat Sontijirawong. A subcommittee has been formed to work out measures to control their prices, which consists of representatives from the ministries of commerce and public health, insurance associations, the Private Hospital Association, the Foundation for Consumers and the National Health Security Office, Minister Sontirat said. Impact on digital health adoption With the implementation of price controls on medical supplies and services, the impact would mostly likely be felt by the private hospitals and healthcare providers since their revenues and profits would be adversely affected. However, on a broader level, the price controls could result in a nationalised standardisation of healthcare terminologies and delivery in terms of how services are ordered. Currently, most hospitals in Thailand, especially those in the private sector, have unique software programs that are designed specifically for their internal use and operate quite comfortably within each institution’s legacy IT systems. What this also means is that it is virtually impossible for electronic information-sharing across hospitals but the price controls may pave the way for a more standardised way of recording health information to facilitate reimbursement both for healthcare providers and payers/insurance providers. A more standardised method of recording and sharing of health information at the national level using IT brings with it several benefits – patients can move across different healthcare organisations without having to bring along their physical paper medical records, reduction of diagnosis/prescription errors as clinicians have a more comprehensive medical record of their patients and potential opportunities for population health analytics with a unified national electronic health record. While the move towards a unified national electronic healthcare record in Thailand may take some time and effort to realise, the new price controls presents a shake-up and enormous opportunities for both public and private healthcare providers to provide more value and quality to their patients through leveraging health IT technologies.

The first employee of the Office of the National Coordinator for Health IT is taking a new role in a different federal unit.

The organization is broadening into a single assessment tool for varying regulations around the world.

A new report from the Duke-Margolis Center for Health Policy explores some of the policy changes that should be made to enable safer and more effective deployment of artificial intelligence in healthcare. As AI and machine learning become de facto ingredients in many key clinical technologies, a better understanding of how they can best be leveraged for optimal analytics and decision support is the goal of the study, "Current State and Near-Term Priorities for AI-Enabled Diagnostic Support Software in Health Care." WHY IT MATTERS The Duke report takes stock of the existing legal and regulatory landscape for algorithm-based CDS and diagnostic support software, and lays out some essential priorities to work toward in the years ahead to ensure safe deployment of AI in clinical settings. These aren't just theoretical concerns. AI and ML are making inroads all over healthcare, of course, and current legislation and regulatory policy – whether it's the massive 21st Century Cures Act or FDA's new updates to the Software Pre-Cert Pilot Program – are adequate but still not optimal for a future that promises to evolve at a dizzying pace. The Duke-Margolis paper, meant as a "resource for developers, regulators, clinicians, policy makers, and other stakeholders as they strive to effectively, ethically, and safely incorporate AI as a fundamental component in diagnostic error prevention and other types of CDS," looks at some of the major challenges and opportunities facing AI in the years ahead. Stakeholders like those listed about will need to grapple with big questions, more than a dozen researchers and authors write. Such as: Making a case for the value of more widespread adoption of these technologies. Such evidence would include how the software improves patient outcomes, boosts quality and lowers cost of care, gives clinicians relevant information in a manner they find "useful and trustworthy." Assessing the potential risk of using those products in clinical settings. "The degree to which a software product comes with information that explains how it works and the types of populations used to train the software will have significant impact on regulators’ and clinicians’ assessment of the risk to patients when clinicians use this software," said Duke researchers. "Product labeling may need to be reconsidered and the risks and benefits of continuous learning versus locked models must be discussed." Seeing to it that such systems are deployed in a way that's both flexible and ethical. More and more health systems will need to develop best practices that can mitigate any bias that could be introduced by the training data used to develop software, they explained. That's the only way to ensure that "data-driven AI methods do not perpetuate or exacerbate existing clinical biases." Also, these organizations will have to think hard about the data implications as the products scale up into settings that may be different from initial use cases. And, of course, "new paradigms are needed for how to best protect patient privacy," according to the report. THE LARGER TREND As the technological capabilities and clinical applications of AI-enabled decision support continue to expand, the Duke researchers said more regulatory clarity from agencies such as FDA, which has signaled an appetite for much wider approval of machine learning apps, is needed to protect patients from wanton use of the "black box" algorithms that many have warned about. In addition, there are other major areas that need ironing-out. Among them: proper allowances for patient privacy and data access, and the ability for these fast-emerging technologies demonstrate value and ROI for providers. In all of those, hospitals and health systems have an active role to play. Then there are all sorts of other technical questions that exist – but haven't necessarily been answered, certainly not on a consistent or widespread basis. Such as: how new approaches to labeling different software might improve understanding of its inner workings; how to weigh the relative risks and benefits of locked versus continuously learning models of AI; how to evaluate its performance over time most effectively; how to mitigate data bias; how to assess "algorithmic adaptability" and more. ON THE RECORD "AI is now poised to disrupt health care, with the potential to improve patient outcomes, reduce costs, and enhance work-life balance for health care providers, but a policy process is needed," said Greg Daniel, deputy director for policy at Duke-Margolis, in a statement. "Integrating AI into healthcare safely and effectively will need to be a careful process, requiring policymakers and stakeholders to strike a balance between the essential work of safeguarding patients while ensuring that innovators have access to the tools they need to succeed in making products that improve the public health," he said. "AI-enabled clinical decision support software has the potential help clinicians arrive at a correct diagnosis faster, while enhancing public health and improving clinical outcomes," added Christina Silcox, managing associate at Duke-Margolis and co-author of the report. "To realize AI’s potential in health care, the regulatory, legal, data, and adoption challenges that are slowing safe and effective innovation need to be addressed." Twitter: @MikeMiliardHITN Email the writer: mike.miliard@himssmedia.com Healthcare IT News is a publication of HIMSS Media.

More and more healthcare organizations are urging a broader swath of the industry to get involved driving interoperability. The latest is a Jan. 22 report from seven leading national hospital associations urging “all stakeholders” to take part. The report, titled, “Sharing Data, Saving Lives: The Hospital Agenda for Interoperability,” outlines some pathways to get the job done. Working with policymakers and other stakeholders, contributors of the report hold that this is what it will take to get interoperability finally where it needs to be in healthcare: data security, enhanced infrastructure, standards that work, connecting beyond EHRs and shared best practices. WHY IT MATTERS According to Chip Kahn, president and CEO of the Federation of American Hospitals, data is everything when it comes to quality care. Having the right information at the right time is critical for clinicians and patients alike.  THE BIGGER TREND Hospitals and health systems are making progress in sharing health information, with 93 percent of them offering the records to their patients online and 88 percent sharing records with ambulatory care providers outside their system. “They have worked to create the most interoperable systems possible given the tools available to them, but at great cost and effort,” the groups added. That said, the federal government is also making moves to bridge the gap in achieving interoperability. Last week, the Office of the National Coordinator for Health IT released its latest version of standards to promote successful interoperability with the Interoperability Standards Advisory Reference 2019. The reference manual is traditionally how ONC coordinates the identification, assessment, and public awareness of interoperability standards and implementation specifications, encouraging all stakeholders — clinical and research — to use them. ONC also encourages pilot testing of the standards. ON THE RECORD “We see interoperability in action all around us,” said AHA President and CEO Rick Pollack. “Mobile phones can call each other regardless of make, model, or operating system. The hospital field has made good headway, but it’s time to complete the job. We are united in calling for a truly interoperable system that allows all providers and patients to benefit from shared health records and data, leading to fully informed care decisions.” The report was written by America’s Essential Hospitals, the American Hospital Association, the Association of American Medical Colleges, the Catholic Health Association of the United States, the Children’s Hospital Association, the Federation of American Hospitals and the National Association for Behavioral Healthcare, and it also names the benefits of fully interoperable data for patients and providers; lists the challenges to getting there and how interoperable records can improve outcomes. Diana Manos is a Washington, D.C.-area freelance writer specializing in healthcare, wellness and technology.  Twitter: @Diana_Manos Email the writer: dnewsprovider@gmail.com  Healthcare IT News is a HIMSS Media publication.   

Organization says 5 will build on FHIR 4 with more normative content, support for apps that use multiple versions of the spec and other advancements.