The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking as part of implementing the 21st Century Cures act. In this series we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.
Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.
This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications. Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.
Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.
I once made a serious error. The patient had taken an overdose of paracetamol, but because I was single-handedly covering three inpatient acute psychiatric wards due to sickness of two other trainees which medical HR had been unable to cover, with a lot of agency nurses who did not know any of the patients well at all, and also because this patient frequently said she had taken overdoses when she had not, and declined to let me take bloods to test for paracetamol levels, I believed she was crying wolf. She collapsed several hours later, and died. I was overwhelmed with feelings of guilt, inadequacy, but also fear – was this the end of my career? I was a trainee psychiatrist at the time – and was immensely fortunate in that my supervising consultant was robust in his defence of me, supported me, whilst fronting the complaint from the patient’s family and attending the inquest. He had been covering two outpatient clinics himself while I was on the ward.
The patient was only 26 years old. Her parents were very angry with me, and not unreasonably so; at the time, it seemed to me that they wanted me to suffer. Twenty years later, I believe they wanted to understand how I made the decision I did. Eventually, the consultant arranged for me to meet the parents. They were very kind to me, all of them, I realise that now. I wasn’t able to give them the answers they wanted. I just cried and said I was sorry.
The mother sent the consultant a letter afterwards which he gave me when I was about to complete that training placement. I did not read it for many months. When I did, I cried. The mother described her daughter’s childhood, the family’s loss, and her own incomprehension that the NHS – which she and generations of her family had venerated as a great institution – could have failed her child. It said very little about me, certainly didn’t seek to blame me, but said a few times that she wanted justice for her daughter. It was an exploration of grief by a bereft mother.
I often think about the mother – I cannot recall the face of the 26 year old patient – but remember perfectly well the mother, who said very little, didn’t even cry, leaving her husband to talk incoherently about justice and a referral to the GMC and the police (they did not do any of these things). And I often ponder the nature of justice they wanted. This was well before the advent of Duty of Candour and rigorously completed serious incident investigations.
Did they get justice? The coroner returned a verdict of suicide, but failed to acknowledge the systemic problems of lack of staff, merely noting that there had a “gap in clinical assessment”. It was not untrue, yet I experienced it as unfair. The consultant reminded me that I was fortunate that the family had not made more fuss. So I let it be. Until the case of Dr Bawa-Garba.
In this episode of Radiology Firing Line Podcast, Danny Huges and I discuss a JAMA paper: A comparison of diagnostic imaging ordering patterns between advanced practice clinicians and primary care physicians following office-based evaluation and management visits.
Listen to our conversation on Radiology Firing Line here.
Saurabh Jha is a contributing editor to THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partner
Imagine solving wicked problems of patient matching, consent, and a patient-centered longitudinal health record while also enabling a world of new healthcare services for patients and physicians to use. The long-awaited Notice of Proposed Rulemaking (NPRM) on information blocking from the Office of the National Coordinator for Health Information Technology (ONC) promises nothing less.
Having data automatically follow the patient is a laudable goal but difficult for reasons of privacy, security, and institutional workflow. The privacy issues are clear if you use surveillance as the mechanism to follow the patient. Do patients know they’re under surveillance? By whom? Is there one surveillance agency or are there dozens in real-world practice? Can a patient choose who does the surveillance and which health encounters, including behavioral health, social relationships, location, and finance are excluded from the surveillance?
The security issues are pretty obvious if one uses the National Institutes of Standards and Technology (NIST) definition of security versus privacy: Security breaches, as opposed to privacy breaches, are unintentional — typically the result of hacks or bugs in the system. Institutional workflow issues also pose a major difficulty due to the risk of taking responsibility for information coming into a practice from uncontrolled sources. Whose job is it to validate incoming information and potentially alter the workflow? Can this step be automated with acceptable risk?
It’s not hard to see how surveillance as the basis for health information sharing would be contentious and risk the trust that’s fundamental to both individual and public health. Nowhere is this more apparent than in the various legislative efforts currently underway to expand HIPAA to include behavioral health and social determinants of health, preempt state privacy laws, grant data brokers HIPAA Covered Entity status, and limit transparency of how personal data is privately used for “predictive analytics”, machine learning, and artificial intelligence.
It is easy for armchair activists to bash randomized controlled trials (RCTs) with clever methodological critiques. However, it takes a lot of effort and coordination to pull off an RCT successfully. In this episode of Radiology Firing Line, I speak with Dr. Mark Neuman and Lakisha Gaskins, principal investigator and research project manager of the REGAIN trial, respectively, about the logic, challenges and intricacies of conducting an RCT. The Regional versus General Anesthesia for Promoting Independence After Hip Surgery (REGAIN) trial is an ongoing pragmatic, multi-center RCT, funded by PCORI, which randomizes patients with hip fractures to regional or general anesthesia.
Guests: Mark Neuman MD MSc, is an Associate Professor of Anesthesiology and Critical Care at the University of Pennsylvania. He is a senior fellow at the Leonard Davis Institute of Health Economics. He’s a former RWJ Scholar. Lakisha Gaskins is a research coordinator with extensive experience recruiting patients for RCTs.
Listen to our conversation on Radiology Firing Line Podcast here.
Saurabh Jha is a contributing editor to THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partner.
Two years ago we wouldn’t have believed it — the U.S. Congress is considering broad privacy and data protection legislation in 2019. There is some bipartisan support and a strong possibility that legislation will be passed. Two recent articles in The Washington Post and AP News will help you get up to speed.
Federal privacy legislation would have a huge impact on all healthcare stakeholders, including patients. Here’s an overview of the ground we’ll cover in this post:
Six Key Issues for Healthcare
We are aware of at least 5 proposed Congressional bills and 16 Privacy Frameworks/Principles. These are listed in the Appendix below; please feel free to update these lists in your comments. In this post we’ll focus on providing background and describing issues. In a future post we will compare and contrast specific legislative proposals.
Jessica DaMassa interviews Paul Simms, the Chairman of eyeforpharma. Eyeforpharma are the “media moguls” when it comes to the Pharma industry. In order to innovate the industry, they are holding two different conferences this year to bring pharma leaders and health technology startups together to foster relationships and strategic partnerships with one another. Their first conference will be held in Barcelona in March, and the second one will be in Philadelphia in April.
Paul speaks to Jess about how health tech startups are maturing in their ways and realizing that health care is an institutionalized game, causing them to pivot their companies’ directions to fit that model. He also comments on how the pharmaceutical industry is trying to build strong relationships with particular startups to innovate their business practices, whether it be in R&D, drug discovery, or clinical research. Paul argues that the future of Pharma is more akin to a platform model, where pharma companies are not just limited to their internal capacity but are much more reliant on a larger ecosystem of moving parts that will help develop and grow the space. He also mentions that Pharma companies could really benefit from taking a page out of Google’s or Facebook’s business model which allows people to innovate and create their own content on these platforms. He further states that large B2C companies, like Amazon, will change the entire game of how people receive and curate their health insurance plans.
eyeforphrama’s conference theme is “medicine is just the beginning”. Paul and his team believe if they bring together specific groups of people, it will benefit the pharmaceutical industry in the short term as well as the long term. Paul believes that “Pharma companies need to have a wider portfolio of innovation that goes far beyond medicine, whether that is drug+plus a solution or without the pill at all.”Currently, Paul states, that the merging of pharma companies with other pharma companies is like having “s*x with your cousins” and believes that Pharma companies need to bridge out of their own space to keep up with the times. If you are a startup in this space, be sure to check out eyeforpharma’s upcoming conferences.
In the industrialized world and especially in United States, health care expenditures per capita has has significantly outgrown per capita income in the last few decades. The projected national expenditures growth at 6.2%/year from 2015 onwards with an estimated in 20% of entire national spending in 2022 on healthcare, has resulted in passionate deliberation on the enormous consequences in US political and policy circles. In US, the ongoing public healthcare reform discussions have gained traction especially with the recent efforts by the Senate to repeal national government intervention with Affordable Care Act (ACA).
In this never ending debate the role of government interventions has been vehemently opposed by conservative stakeholders who strongly favor the neoclassical economic tradition of allowing “invisible hands” of the free market without minimal (or any) government regulations to achieve the desired economic efficiency (Pareto optimality).
A central tenet of this argument is that perfect competition will weed out inefficiency by permitting only competent producers to survive in the market as well as benefit consumer to gain more “value for their money” through lower prices and wider choices.
Restrained by limited societal resources, in US to make our health market ‘efficient’ we need to aim for enhancing production of health services provision at optimal per unit cost that can match consumers maximum utility (satisfaction) given income/budget restraints.
Keeping asides the discussion on whether a competitive market solution for healthcare is even desirable as adversely impact the policy objective of ‘equity”, however from a pure ‘efficiency’ perspective it is worthwhile to focus on the core issue whether conditions in healthcare market align with the prototypical, traditional competitive model for efficient allocation of resources.
We almost forgot to do Health in 2 Point 00 at HIMSS—but don’t worry, here it is. On Episode 70, Jess and I give you a rundown of everything that happened at HIMSS. Jess asks me about the biggest gossip at HIMSS (anyone notice Atul Gawande wasn’t there?), all the talk about ONC rules, new and exciting things at the exhibit hall, and the best and worst parties of HIMSS.—Matthew Holt
What are the challenges of getting imaging to Africa? In this episode of Radiology Firing Line, I convene a panel of experts in Africa. We discuss the challenges of bringing new technology to Africa, the new need for imaging driven by public health gains and increased longevity of Africans, the insalubrious practice of “equipment dumping”, amongst others.
Kassa Darge, MD PhD, is Professor of Radiology and Radiologist-in-Chief at Children’s Hospital of Philadelphia. He is also Honorary Professor of Radiology in the Department of Radiology at Addis Ababa University in Ethiopia.
Omolola Mojisola (Monica) Atalabi MBBS MBA, is Professor of Radiology and Chief of Pediatric Radiology at University College Hospital, Ibadan, Nigeria. She is President of both the Association of Radiologist in Nigeria and the World Federation of Pediatric Imaging.
William Sykes is the CEO of Tecmed Arica – a medical equipment, device, service and training provider in the Southern African region.