The women of healthcare standards

Photo: IEEE Standards Association

It's an unfortunate reality that men significantly outnumber women in leadership positions in health IT – which is part of why Healthcare IT News' sister publication Women in HIT profiles the work of women in the industry.

Today, Healthcare IT News is featuring an interview with Maria Palombini, director of healthcare and life sciences practice leader at the IEEE Standards Association. 

Palombini offers an in-depth look at four high-profile women in health IT who are doing major work in creating and promoting healthcare standards: Heather Flannery, CEO of ConsenSys Health and chair of the HIMSS Blockchain Task Force; Dr. Madhuri Gore, professor and tech director at the Dr. S.R. Chandrasekhar Institute of Speech and Hearing; Florence Hudson, CEO of FDHint and executive director of the Northeast Big Data Innovation Hub at Columbia University; and Dr. Ida Sim, professor of medicine at the University of California San Francisco and co-director of informatics and research innovation at UCSF's Clinical and Translational Sciences Institute.

Palombini talks about the importance and influence of these four healthcare leaders, the value of the female perspective in healthcare, and some of the challenges they and their teams are facing in addressing a critical piece of the digital health puzzle.

Q. Heather Flannery is CEO of ConsenSys Health and chair of the HIMSS Blockchain Task Force. What kind of standards work is she doing and how does her leadership help boost standards?

A. Heather Leigh Flannery serves as the chair of IEEE P2418.6: Standard for the Framework of Distributed Ledger Technology Use in Healthcare and the Life and Social Sciences. The working group chair may be appointed by the IEEE Standards Committee or elected by the working group members.

Heather was the author and submitter of the IEEE P2418.6 Project Authorization Request, which is a structured and highly detailed document that essentially states the reason why the standard project exists and what it intends to do.

Part of IEEE SA's blockchain initiative launched in 2018. As an early mover in this field, this standard will provide a common framework for distributed ledger technology usage, implementation and interaction in healthcare and the life and social sciences, addressing scalability, security and privacy challenges. DLT tokens, smart contracts, transactions, assets, networks, off-chain data storage and access architectural patterns, and both permissioned and permission-less DLT, are included in the framework.

One of the most valuable contributions is using the IEEE global platform to drive engagement with others working on standards in this field. We have about 150 active members in this working group, including comprehensive involvement from both the public and private sector, representatives from global governments, and multiple parties across academia.

While this technology aims to improve efficiency, healthcare brings unique challenges and special attention. The purpose of this standard is two-fold. First, it is to provide a common semantic model and framework for the usage of blockchain and DLT in healthcare and the life and social sciences, under which a body of detailed, complementary standards specific to myriad niche use-cases can be subsequently developed.

Second, it is to clarify and rationalize the use of DLT in healthcare and the life and social science in concert with converging innovations relevant to the sector, including, but not limited to, the family of artificial intelligence and the Internet of Medical Things, delivering healthcare-specific coordination of these adjacent-standards activities. This involves both opportunities for value creation as well as risk mitigation challenges.

Of great significance, IEEE SA Open Source has been incorporated into IEEE P2418.6.

In addition to Flannery's leadership as CEO of ConsenSys Health and chair of the HIMSS Blockchain Task Force, she also served as the FY19 co-chair of the global HIMSS Blockchain in Healthcare Task Force and chairs the Healthcare Special Interest Group at the Enterprise Ethereum Alliance. She is an associate editor of the peer-reviewed journal, Frontiers Blockchain for Science.

Flannery is also an Innovation Fellow at EP3 Foundation, has served as industry faculty for the U.S. Department of Health and Human Services Office of the National Coordinator for Health IT, and is an active consultant, advisor and keynote speaker.

Q. Dr. Madhuri Gore is a professor and tech director at the Dr. S.R. Chandrasekhar Institute of Speech and Hearing. What kind of standards work is she doing and how does her leadership help boost standards?

A. Dr. Madhuri Gore is the vice chair of IEEE P2650 – Standard for Enabling Mobile Device Platforms to Be Used as Pre-Screening Audiometric Systems. This standard will establish the performance, interoperability and validation requirements of a mobile device platform that typically consists of a mobile phone device in conjunction with a portable or wearable device and associated software, to be used as an audiometric pre-screening device. Gore was appointed as vice chair by the chair of standards working group and supported by the fellow group members.

This project is particularly important to emerging economies, including Gore's native India, where diagnostic screenings are out of reach to most of their populations due to accessibility, affordability and other roadblocks. According to the World Health Organization, globally, 1.5 billion people suffer from hearing loss and 430 million suffer from disabling levels of hearing loss that can be mitigated. With the emergence of mobile devices, the opportunity exists to meet these challenges.

The impact of standards for mobile devices used for hearing pre-screening is enormous in terms of scope and the byproduct issues some suffer with hearing loss. The standard will enable use in remote and rural areas, and also drive awareness and prevention of secondary issues, such as depression, unemployment, cognitive decline and dementia, and academic underachievement.

Gore has worked as an audiologist since 1982, including an extensive focus on children with hearing loss. She has conducted neonatal hearing screening, and participated in school screening and rural hearing screening programs for the early identification of hearing loss.

Additionally, Gore is experienced with cochlear implants and has been part of a team that provided guidelines to the government of Karnataka cochlear for its implant program. She currently holds a post as a professor in the Department of Hearing Studies at the Dr S.R. Chandrasekhar Institute of Speech and Hearing. Gore previously served as president of the Indian Speech and Hearing Association and vice president of CIGI.

Q. Florence Hudson is CEO of FDHint and executive director of the Northeast Big Data Innovation Hub at Columbia University. What kind of standards work is she doing and how does her leadership help boost standards?

A. Florence Henderson chairs the working group for IEEE P2933: Standard for Clinical Internet of Things Data and Device Interoperability with TIPPSS – Trust, Identity, Privacy, Protection, Safety, Security.

Florence originally initiated this work as a pre-standards incubation activity under the IEEE SA Global Wearables and Medical IoT Interoperability and Intelligence Program. After amassing a group of more than 100 volunteers in the incubation work, they achieved consensus to move forward and submit the PAR to become an official IEEE standards working group.

As the author, submitter and original leader of this incubation activity, the IEEE Standards Committee and working group members supported Florence as the chair of this working group. This standard, the first under development in partnership with Underwriters Laboratories, will establish the framework with Trust, Identity, Privacy, Protection, Safety Security principles for Clinical Internet of Things data and device validation and interoperability.

This includes wearable clinical IoT and interoperability with healthcare systems, including electronic health records, other clinical IoT devices, in-hospital devices, and future devices and connected healthcare systems.

The primary reason for this standards project is that everything is reachable and hackable, including things you might not imagine, such as the weight scale in your home that reports real-time findings to your doctor.

For example, in 2017, the FDA recalled more than 465,000 pacemakers due to hacking concerns. Adjacency is an issue: you can be within 50 feet or so and hack a person's wearable device. Thus, the mission is to protect healthcare devices and data against device, hardware, software and service hacks.

Of course, the risks of a hack can be enormous, including loss of information and privacy – and life-threatening for some. An expert in TIPPSS, Henderson says this is the new and best cybersecurity paradigm for healthcare IoT and other uses.

Focus on this issue began about five years ago, and Henderson was instrumental in launching the standards working group in 2019. The group comprises more than 250 members from 22 countries and six continents.

Members include representatives of device manufacturers, regulators, the National Institutes of Health, the National Cancer Institute, providers, payers, patient advocates, pharmaceutical companies, technologists, EHR/EMR vendors, researchers, academics, startups, the Hyperledger community and, of course, Underwriters Laboratories.

Henderson is CEO of the Northeast Big Data Innovation Hub at Columbia University, and is the founder and CEO of FDHint, a global advanced technology and diversity and inclusion consulting firm. She leads the COVID Information Commons funded by NSF, providing an open resource to explore research and enable global collaboration to address the COVID-19 pandemic.

Henderson's career includes her leadership as vice president and chief technology officer for IBM, senior vice president and chief innovation officer at Internet2, special advisor to the NSF Cybersecurity Center of Excellence, and aerospace engineer at NASA and Grumman. Henderson also is an author, publishing a book about TIPPSS.

She currently serves on boards for Princeton University, California Polytechnic State University (San Luis Obispo), Stony Brook University, Blockchain in Healthcare Today, and the IEEE Engineering in Medicine and Biology Society. She earned a BSE in Mechanical and Aerospace Engineering from Princeton University, and executive business education from Harvard and Columbia universities.

Q. And Dr. Ida Sim is a professor of medicine at the University of California San Francisco; co-director of informatics and research innovation at UCSF's Clinical and Translational Sciences Institute; and co-founder of Open mHealth. What kind of standards work is she doing and how does her leadership help boost standards?

A. Dr. Sim serves as chair of IEEE 1752.1™-2021: Standard for Mobile Health Data.

Mobile and wearable devices are being increasingly developed for healthcare purposes. Mobile health data encompasses personal health data collected from sensors and mobile applications: digital biomarkers, which are physiological and behavioral measures collected by means of digital devices such as portables, wearables, implantables or digestibles that characterize, influence or predict health-related outcomes.

Sim is the author and submitter of the PAR for the IEEE 1752.1 standard and now just approved IEEE P1752.2 standards working group. The standards working groups are a product of the work that was envisioned at Open mHealth, a nonprofit group making patient-generated data accessible through an open data standard and community.

Standardizing mHealth data and metadata will improve the ease and alignment accuracy of aggregating data across multiple mobile health sources (semantic interoperability) and will reduce the costs of using this data for biomedical discovery, improving health, and managing disease. As a starting point, this working group is focused on specifications for standardized representations of quantitative sleep and physical activity measures, minimum metadata, and subjective reports (surveys) defined by this IEEE 1752.1 standard.

The purpose of this standard is the provision of standard semantics to enable meaningful description, exchange, sharing, and use of such mHealth data. Data and associated metadata complying to this standard will be sufficiently clear and complete to support their use for a broad set of consumer health, biomedical research, and clinical care needs.

Standardizing mHealth data and metadata will yield several benefits, including making data exchange and reuse predictable and constant; making data aggregation across multiple sources easier and more accurate; facilitating development and validation of digital biomarkers; and reducing costs of using mHealth data for care and research. Consider that data comes from a million, if not millions, of people; it needs to come across in a standardized way.

Additionally, with an Open mHealth approach to data sharing, we can have common schemas to structure data and can provide open-source tools to validate data, pull in data from large and popular device manufacturers, and store data and share it securely with others.

This working group is composed of 243 global members representing industry, academia, government, regulatory agencies, clinical researchers and more.

Now, the focus is moving forward with a new work group: P1752.2, the Standard for Mobile Health Data: Representation of Cardiovascular, Respiratory, and Metabolic Measures. The first working group meeting was held this past July. This will include a pilot, using synthetic data, to test the standard.

Sim is a professor of medicine at the University of California, San Francisco, and co-directs informatics and research innovation at UCSF's Clinical and Translational Sciences Institute. She also is the director of digital health for the division of general internal medicine.

Sim's research focuses on open integrated architectures of mobile technologies for clinical research and primary care. She is a global leader in the policy and technology of large-scale sharing of clinical trials and mobile health data. In 2011, she co-founded Open mHealth.

In 2017, she co-founded Vivli, a global data sharing platform for finding, requesting, and analyzing participant-level clinical trials data. Sim has served on multiple advisory committees on health information infrastructure for clinical care and research, including committees of the National Research Council and National Academy of Medicine.

She is a recipient of the United States Presidential Early Career Award for Scientists and Engineers, a Fellow of the American College of Medical Informatics, a member of the American Society for Clinical Investigation, and is a practicing primary care physician.

Q. What special value does the female perspective bring to healthcare and standards?

A. Women are leading the way in every aspect of the digital health tech transformation: They are founders of start-ups, CEOs of major organizations, or solving everyday complex challenges with the adoption and use of health technologies. Above and beyond their experience and expertise, consider that 77% of frontline health and long-term care workers are women, according to Becker's Hospital Review.

Women hold 30% of C-suite positions with healthcare companies, 13% of them in the healthcare innovation space, according to consultancy firm OliverWyman. Of the hundreds of companies in the investment firm Start-Up Health's VC Fund portfolio, 32% were founded by women. Lastly, more than 80% of household decision makers for healthcare are women, according to the U.S. Department of Labor.

Women are playing a leading role in healthcare, and rightfully so, whether it be in healthcare technology or leading from the C-suite – and developing standards.

Here at IEEE SA, we have a large representation of women across the globe, including these four extremely talented people who are leading standards development within our healthcare practice, focused on security, validation and protecting the privacy of patient data while distributing and integrating it for diagnostics, monitoring or clinical research.

Each of them leads groups that include the participation of a very diverse volunteer group of hundreds of professionals from across the globe. They are unified in their commitment to development and adoption of standards, which ultimately lead to better healthcare outcomes.

Q. What are some of the challenges these women and their teams face in addressing a critical piece in the puzzle impeding trust, security and validation in digital health?

A. When these practice leaders presented on a recent webinar hosted by IEEE SA, 58% of viewers polled during the presentation said the foremost challenge involved distrust in the use of medical technologies due to threats and vulnerability risks. Other concerns include lack of data and/or device interoperability; lack of patient identity, data, and device validation; and lack of accessibility and feasibility.

These underlying issues are symptomatic of when innovation is outpacing trusted adoption in the market. The growing use of devices – in, on and around the body – for mobile/remote Patient Monitoring also increases the concerns with the use of these devices when many of these critical challenges are not resolved.

The development of consensus-driven standards in addressing continuous questions on validation, interoperability, feasibility, privacy, and ethics may be able to deliver the credibility and trust that all stakeholders – patients, clinicians, regulators, researchers and more – are seeking in order to drive wide adoption for healthcare delivery and clinical research use.

More critical focus should be placed on both technical and policy considerations. A global community of leaders in healthcare, technology, and policy is needed to develop mutual understanding and recommendations for standards to address the threats and vulnerabilities embedded in the connected healthcare arena. There remain many gaps in the connected healthcare as it relates to security, privacy, ethics, trust, and identity, including data and device validation and interoperability.

Resulting recommendations could include technical solutions such as systems of systems reference architecture and/or integrated systems design approach for more comprehensive visibility and detection into the many connected elements within these systems. The future of medical devices, mobile or stationary, will heavily be AI-powered, which will add another element of uncertainty when it comes to trust and adoption.

To truly realize the potential innovation of these devices and the impact they can have on enhanced patient outcomes and contribute towards precision medicine, the issues of security, privacy, interoperability and validation need to be addressed in the form of consensus-driven standards, where the application of the standard makes it seamless for the users to trust that the products and services will work in an ethical, secure, and verified manner.

We should move away from carrying this baggage of continued uncertainties, to open the doors to future innovation.

Twitter: @SiwickiHealthIT
Email the writer: [email protected]
Healthcare IT News is a HIMSS Media publication.

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