The Business Case for Social Determinants of Health

By JESSICA DaMASSA, WTF HEALTH

How can understanding the underlying social risks impacting patient populations improve health outcomes AND save health plans some serious per-member-per-month costs? You’re probably familiar with the concept of ‘Social Determinants of Health’ (SDOH) but Dr. Trenor Williams and his team at health startup Socially Determined are building a business around it.

By looking at data around what Trenor calls ‘the Significant 7’ social determinants (social isolation, food insecurity, housing, transportation, health literacy, and crime & violence) he and his team are working to help health plans intervene with their most vulnerable populations and bring down costs.

What kind of data is Socially Determined looking at? Everything from publicly available data on housing prices and air quality, to commercial datasets on buying preferences and more. Plus, with help from their health plan partners, they’re using clinical and claims data to create a complete picture of health care spend, utilization, and outcomes.

Trenor walks through some very specific examples in this interview to help illustrate his point. In one, Socially Determined was able to identify how Medicaid could better help asthmatics manage their asthma AND save a thousand dollars per affected member each month. Another project in Ohio identified that a mother with a history of housing eviction was 40% more likely to give birth to a baby requiring NICU care – opening up myriad opportunities for early intervention and the potential to positively impact the lifetime health of both mother and child.

As healthcare continues to realize it’s ‘data play’ – and look beyond the typical data sets available to healthcare companies – the opportunities for real and meaningful impact are tremendous. Listen in to hear more about what Trenor sees as the new opportunity for Social Determinants of Health.

Filmed at AHIP’s Consumer Experience & Digital Health Forum in December 2018.

Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health

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Interoperability and Data Blocking | Part 1: Fostering Innovation

By DAVE LEVIN MD 

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.

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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.

The simultaneous announcement reflects the coordinated effort between CMS and ONC to make the most of their respective regulatory powers. ONC is acting to set the basic requirements for certification and use of health IT while CMS is tying the proper use of certified health IT to conditions of participation. Put simply, ONC is defining how health IT companies, providers and others should behave, and CMS is tying compliance with those behaviors to payment for services. This powerful set of carrots and sticks have proven quite effective in the past.

Competition is a key theme of the ONC and CMS rules. They are designed to create a more level playing field and foster market-driven innovation.  The intent is to cure the current innovation constipation afflicting health IT by empowering more players to get on the field and compete to provide the best, most innovative solutions at the lowest prices.

In this series, we will explore this theme of market-driven innovation by examining specific aspects of the proposed rules. We will look at why rules are needed and their expected impact including:

  • Interoperability Technology: Application program interfaces (APIs) have transformed the rest of the digital economy. Why do the rules mandate the certification, adoption, and use of APIs as the next generation of interoperability infrastructure? What role will standards like FHIR play?
  • Business Models and Intellectual Property: What practices inhibit competition and innovation? How do we balance the need for competition with protection of legitimate intellectual property rights and reasonable profit motives?
  • Data: What specific data elements are part of the rules? Why is defining a core data set important?
  • Health Insurance Data: What are the new requirements for health insurance providers and why are they important?
  • Data Blocking: What is data blocking? How do the proposed rules address data blocking? What “exit ramps” are provided for patients and providers who want to switch from one application to another and/or take their data with them?
  • Safety: How do the new rules address patient safety and promote the development of safer health IT applications and practices?
  • Security and Privacy: How do the new rules impact patient privacy and the security of health data?

Health care has made substantial progress moving into the digital age and is positioned to build on this early success. Robust interoperability technology coupled with regulations designed to enhance competition are essential to accelerating and expanding this transformation. Digital technology has radically altered and largely improved the way we shop, bank, travel, and socialize. It’s now within our grasp to leverage this powerful technology to improve our health.

Dave Levin, MD is co-founder and Chief Medical Officer for Sansoro Health where he focuses on bringing true interoperability to health care. Dave is a nationally recognized speaker, author and the former CMIO for the Cleveland Clinic. He has served in a variety of leadership and advisory roles for health IT companies, health systems and investors. You can follow him @DaveLevinMD or email Dave.Levin@SansoroHealth.com

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Our Dead on Every Shore

By MAYURA DESHPANDE 

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.

The case of Dr Bawa-Garba has been widely reported and analysed. Hadiza Bawa-Garba was a trainee paediatrician who was convicted of gross negligence manslaughter in 2015 after the death of 6 year old Jack Adcock from sepsis in Leicester Royal Infirmary. On the day in question in 2011, Dr Bawa-Garba, who had recently returned to work following maternity leave, with previous experience of community paediatrics, was sent to work on the children’s assessment unit instead of the general paediatric ward she was expecting to work on. There were medical and nursing shortages and the consultant who should have been supervising her was elsewhere. Shortly afterwards, Jack, who had Down’s syndrome, became very unwell. The computer system which would have provided lab results of blood tests was down for some time. The consultant arrived later in the day, by which time Dr Bawa-Garba believed that Jack was responding to treatment for her working diagnosis of gastroenteritis. An agency nurse failed to record observations regularly. Later still, when Jack became more unwell, Dr Bawa-Garba, who had been on duty for twelve hours by then, confused Jack with another patient who had a “Do Not Resuscitate” order due to room changes she did not know about. In the event, despite resuscitation, Jack died of sepsis.

Subsequent events saw the consultant criticised for getting Dr Bawa-Garba to share her reflective portfolio, and for stating that she had failed to stress to him how unwell Jack was.

Dr Bawa-Garba was charged and convicted of gross negligence manslaughter. She was recommended for a 12 month suspension by a medical practitioners tribunal. But the GMC appealed to High Court, and she was struck off in Jan 2018. However, a further legal challenge saw the Court of Appeal overturn that ruling, deciding that the tribunal was correct to take into account the systems failure in the hospital. This was welcomed by the medical profession in the UK, who pointed to, among other things, the hospital’s own investigation which identified numerous systemic failings, including chronic under-staffing and poor governance.

However, the family of the little boy, who are vocal on social media and have steadfast supporters among the public, have stated repeatedly that they believe that Dr Bawa-Garba and a nurse caused the death of their son, and that her erasure from the medical register was an appropriate and proportionate sanction. Can anyone fail to be moved by their grief, their disbelief at the expert opinion shared at the inquest that the death was avoidable, their desire for justice for their son and for their family?

But there have been other cases. Different patients, different families, different illnesses, different circumstances. But with some themes that start to emerge. Criticisms of the individual clinicians, organisations, Boards, commissioners, the NHS, its complaints and serious incident investigation systems, the Department of Health. Families are increasingly united in their views of the above.

The families in various cases have also condemned the British coronial system as out of date, inherently prejudiced in favour of the state institution as the NHS has access to legal advice, whilst bereaved families have no such automatic right. The commissioners of services have come in for criticism too, with the charge that they have failed to assure themselves of the quality and safety of services which they pay for with public money.

The other thing which many cases have in common is that the doctors and nurses concerned – all heavily criticised by the families of those who have died – have stated in their defence that they worked in hospitals which had systemic problems, be they due to chronic understaffing, lack of adequate supervision and support, stressful daily conditions, poor governance, senior management who were aware of these problems but either not prepared to or unable to solve them, and a culture of fear created by the rather unforgiving consequences of errors. Commentators – including doctors and journalists – have proposed a variety of explanations, saying that this was due to an imbalance between power wielded by doctors as opposed to nurses, that it was one rogue doctor, that it was the senior doctors who failed to supervise the junior doctor properly and got away scot-free, that the GMC was behaving in a populist manner instead of being balanced and fair, that the British public did not appreciate or acknowledge that doctors and nurses are working in a failing system, that the doctor was being scapegoated because of her racial origin, that this was yet another symptom of rule by an uncaring right-wing government, and so on.

When we can identify a single error – different medications with similar labelling leading to understandable confusion, one wrong decision which does not seem to have been caused by other factors but is an end in itself, and even one individual who lied or cheated – the bad egg – these are easier in some ways to resolve for the public and the profession. However, the cases mentioned above are highly likely to be multifactorial in their causation, and those factors themselves are multi-faceted and prone to dissection along the lines of various ideologies.

Many of these cases, and others where bereaved families are seeking answers and justice with little media reporting, will continue to cause consternation both in the public and clinicians because they are polarising. It is all too easy for doctors and nurses and other healthcare professionals, familiar with the daily grinding challenges of working in an underfunded, assurance-driven system to experience a sense of “there but for the grace of God go I”, and be driven to support the clinicians involved. And for the families, it is perhaps inevitable that they experience a type of epistemic injustice, deprived as they are of the knowledge that those in the system have, both regarding the circumstances of the death of their loved one, and of what happens next – unfamiliarity with the coronial system, the unwieldy NHS serious investigation framework and complaints systems – coupled with a very real lack of individual support, access to financial assistance, and a sense of clinicians “closing ranks”. Whatever the final verdict – legal or that determined by public opinion – in these cases, it is likely that a sense of unfairness will continue to be experienced by one or both sides.

When a patient dies in care of the state, is there a version of justice that is fair to all? Can there be a process and an outcome that acknowledges the human cost to all parties – the family, the doctor and other healthcare professionals involved – and be fair to the people involved, but also to institutions like the employing organisation, the system that is the NHS? If there is, what would that look like? And how can we avoid the individualism vs. collectivism trap inherent in the argument that an NHS that serves all will occasionally fail and we must accept those instances?

The answer, unsurprisingly, is not straightforward.

Families who are bereaved due to omissions or commissions in healthcare might say that they want a system of transparency and clear accountability when things go wrong, and for people who have erred to be appropriate punished. I have lived though, as a clinician, the years of “no blame” (which concept I must say I found inherently unfair to patients and families) and the zeitgeist of “just culture”. We now have the Healthcare Safety Investigation Branch which sets out to conduct exemplar investigations, albeit only in highly selected cases. The public mood, at any given time, threatens to move away from having some vestiges of trust in the NHS to demanding public enquiries and the head of the clinician on a stick.

Some things would help create a more level playing field – such as the automatic provision of legal aid for families who lose a loved one in the care of the state, in recognition of the legal and financial wherewithal available to state institutions. This is easy to recommend, difficult for a cash-strapped public service system to implement. But this alone might go some way towards persuading the public that the NHS, and the state, take the issue seriously.

Good governance – not one driven by the ever-decreasing circles of auditor-designed assurance – might help, both clinicians and patients and their families. This again is appealingly intuitive but difficult to design and maintain, which requires the type of time and resource that the NHS’s hamster-wheel does not want to contemplate.

It was said, regarding the Mid Staffordshire enquiry, that no one comes to work to do a bad job. This statement is appealing, but I have seen bereaved families react very negatively to this – and it had made me reflect that when one is the victim of poor care by the state, and answers are slow to come or so complex that obfuscation seems to be the only explanation, individual culpability, such as it may be, becomes one in the mind of the public with systemic responsibility. This is understandable, and if we were able to think about this in public debates, discussions might be less polarised, less framed along the lines of family vs. state, or family vs. doctor/nurse/clinician, or family vs. doctors, or doctors vs. the GMC. The risk of course is of appearing patronising to a family that is grief-stricken and angry, entirely legitimately looking for justice.

Clinicians, even in the age of Dr Google, wield enormous power and influence – the nature of illness is such that one is rendered vulnerable. Doctors and nurses would do well to remember that even when patients and their families are very well informed and articulate, there is an inherent and inescapable power-differential, especially when adverse events occur, and patients and families see the institution as seeking to protect its reputation. Clinicians see this too – institutions are living beasts and in the NHS, itself a large sentient organism – clinicians too can feel abandoned by the institution that employs them. However, in most cases, I would suggest that clinicians still have access to resources and information that is not easily available to members of the public.

But above all this, I suggest, it is time to have debates with the public about the nature of errors, especially medical or clinical errors, in imperfect systems – and to explore the idea that all systems are imperfect the moment a human designs them or is part of them. This is not to say that individual responsibility, and culpability within the law, do not exist, or are not important.

There is a vast body of literature on the nature of medical errors, distinguishing errors from violations and from deliberate harm. The Williams review of the gross negligence manslaughter, commissioned in the wake of the outcry from the medical fraternity in the UK on the prosecution of Dr Bawa-Garba, was published in June 2018 and its recommendations cautiously welcomed by various Royal Colleges, and accepted by the government; these changes, seeking to limit the power of the GMC, and developing an agreed understanding of gross negligence manslaughter, among others, will help restore a measure of confidence in the system which is experienced by many clinicians as stacked against them. These changes should prompt a wider debate on the nature of errors and the contribution of systemic, as opposed to individual, factors when an adverse event occurs in healthcare. This debate will need to acknowledge that errors by an individual can occur in the absence of systemic problems, but also that endemic systemic problems like chronic lack of qualified staff, lack of time, lack of adequate training and supervision, lack of good governance, a culture of blaming the individual will all make errors by individuals more likely, but more importantly, will make these errors by individuals more likely to result in catastrophic outcomes.

Should the public be made aware of the extent of problems faced by the NHS? Yes, indubitably so. Would this reduce confidence in the NHS? Yes, it may, in the short term. But the NHS, with its chronic, very well-documented problems, arising from increasing demand, limited and shrinking capacity, and very high expectations of the public, as well its status as a political sacred cow, needs to have its reality laid bare to the public, because that is the only way that the public can understand what a doctor or nurse going to work in a mental health team or an emergency department or primary care faces, the odds against which a patient gets good care, and in understanding this, will start to see what is meant by systemic problems on the backdrop of which errors occur. This acknowledgement is necessary for the NHS to be truly owned by the public.

The other thing which appears to rarely find its way into public discourse is the acknowledgment that everyone, even those with access to private healthcare, uses the NHS, if only for major illnesses and emergency care. This means that at one time or another, we are all patients, or family members of those who use the NHS. The above issues affect us all.

The point of good investigations when adverse events occur in healthcare is not to find reasons to excuse the individual, or to silence the questioning family, but to genuinely identify those areas which can be improved, to find ways, if they exist, to reduce the likelihood of similar errors from recurring, and where it is the case that there is individual culpability, to ensure that appropriate sanctions are deployed, which may take the form of criminal charges in some cases. We cannot achieve this ideal, peddled to us in many forms by the Department of Health, as things stand. Would good investigations, enabling families to access support, advocacy and financial assistance, and public debate on the issues outlined above guarantee justice which is acceptable to victims and those held to be responsible for adverse events? No. But it may help to create an environment which is less polarised and seeking to blame.

I had decided to keep the letter from my patient’s mother. I read it only twice, because it was so heart-rending. But some years later I moved house, and the letter was lost. I am not sorry to not have it any more. I had two episodes of severe depression requiring treatment and therapy, and many hours of other interventions to rebuild my confidence in my ability. But my sense of failure, and my sense of unfairness at the circumstances in which my patient died, has stayed with me. The mother’s words, and her sense of betrayal and injustice, have also stayed with me. She did not get justice, her daughter did not get justice, but neither did I.

Dr Mayura Deshpande is a forensic psychiatrist and associate medical director working with adolescents in Southampton, England. Her interests include ethics, law and investigation of adverse events in healthcare. She is chair of the Ethics and Professional Practice Committee of the Royal College of Psychiatrists.

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Advance Practice vs Primary Care

By SAURABH JHA MD SAURABH JHA

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

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ONC’s Proposed Rule is a Breakthrough in Patient Empowerment

By ADRIAN GROPPER

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.

For more on the latter, I recommend Shoshana Zuboff’s work on surveillance capitalism, nicely summarized in this Data and Society talk:

The conventional approach to dealing with the issues raised by a desire to have data follow the patient is to invent or conceive various forms of health information exchange (HIE). To the hospitals and their electronic health record (EHR) vendors, shifting the problem to a new and separate entity makes total sense since it transfers responsibility (and cost) for privacy, security, and some workflow issues to others and leaves them to focus on the institutional silo that they can manage and control. The physicians and patients will just have to deal with it. There has been over a decade of HIE “invention,” starting with the Markle Foundation in 2006, the Nationwide Health Information Network in 2007, HITECH in 2009, state HIE subsidies, more recently CommonWell and its EHR vendor-operated cousins, and most recently the Trusted Exchange Framework and Common Agreement (TEFCA) that is also in the current NPRM.

It’s hard to predict how changes to HIPAA or novel HIE frameworks will evolve, but patient empowerment or the goal of a patient-controlled longitudinal health record, are hardly considered as the desired outcome. Regardless of how one defines a longitudinal health record, we might agree that it should follow the patient by being accessible to the physicians and other caregivers designated by the patient “without special effort,” a phrase that appears on 34 different pages in the NPRM.

Throughout this post, words in bold are terms used in the NPRM or ONC fact sheets.

The NPRM specifies standards and practices that enable automation for how a certified health record system exposes an application programming interface (API) that the patient or patient designee can access. The definition of designee is the core of the breakthrough and is best understood via this paragraph on page 452:

“A fee based on electronic access by an individual or their personal representative, agent, or designee to the individual’s EHI, in contrast, would arise if an actor sought to impose on individuals, or their personal representatives, agents, or designees, a fee that operated as a toll for the provision of electronic access. For example, a health care provider that charges individuals a fee in order that the individuals be given access to their EHI via the health care provider’s patient portal or another mode of web-based delivery, would not be able to benefit from this exception. Similarly, where an individual authorizes a consumer-facing app to retrieve EHI on the individual’s behalf, it would be impermissible for an actor to charge the app or its developer a fee to access or use APIs that enable access to the individual’s EHI. This would be true whether the actor is a supplier of the API technology or an individual or entity that has deployed the API technology, such as a health care provider.”

The clarity of that last sentence is breathtaking. It augurs a solution to consent, patient matching, and workflow issues at once. Let’s examine the practices under the NPRM that combine to create this solution. To do that, it’s easiest to start from the workflow issue and work backward to patient matching and consent.

The workflow issue is really about money.

Whether a practice manages incoming health record information manually or automatically, the risks are significant and so are the costs. Take, for example, an abnormal lab result or radiologist’s impression on an incoming message. The practice has to check whether this is a new finding, decide if they are responsible for follow-up, and capture the decision within their EHR and their workflow. If they are are subject to value-based payment, the follow-up can be a direct hit to the bottom line.

In any case, the follow-up will mean some risk and some out-of-pocket cost to the patient. By stating clearly that the designee can be a health care provider and their API technology, the NPRM is empowering the patient or their insurance to pay for the workflow costs they are creating. This effectively gives every patient the opportunity to pay for their longitudinal health record to be managed by anyone they choose, regardless of where they are actually receiving the majority of health care services. The standards and practices of the NPRM are designed to keep the cost of a patient-controlled longitudinal health record to a minimum the same way as mandated issue of standard W2 and 1099 tax forms empowers a person to choose an accountant to process their income at reasonable cost.

Once the patient is empowered to designate and pay for the processor of their longitudinal health record the potential providers have a financial incentive to install standard APIs with patient portals and even advanced features such as automation. Let’s refer to this as the designee patient portal – related to what the NPRM calls the API User – to distinguish it from the hospital patient portal – related to the NPRM’s API Data Provider.

Once the patient has access to both the designee patient portal and the hospital patient portal in a single standard transaction, the patient matching problem is solved. The patient is now responsible for the match. There is no cost or risk to neither the designee or the hospital because both ends of the API transaction identified the patient however they want when they issued the patient a username and password to their respective patient portals. The importance of this from a privacy perspective cannot be understated. Patient matching without patient involvement is the essence of involuntary surveillance. Recent efforts to improve the performance of probabilistic patient matching have introduced the concept of “referential matching” which employs surveillance by data brokers and credit bureaus beyond healthcare. It’s hard to imagine a more coercive and trust-eroding approach.

Finally, empowering the patient to link the API Data Provider to their designated API Data User provides an opportunity for consent. Although the specifics of what choices are offered to the patient and how they are labeled in an understandable, standardized manner still require work, the clarity and power of the patient designee in the NPRM is clearly a breakthrough in consent.

Under the information blocking mandate, ONC needs to interpret the meaning of “without special effort” in the 21st Century Cures act.

Most of the NPRM seems designed to provide private-sector incentives to make the physician and patient experience as effortless as modern standards and technology allow. To get the patient-matching, consent, and workflow benefits described above, it is essential that patient engagement be limited by default. Designated health care providers should not be delayed by multi-step patient actions spread over five days before API access is enabled.

Ideally, all of the steps required for designee access should be built into the patient’s registration with a new health care provider, similar to how registration captures insurance information. For example, a registration kiosk could be integrated with the patient portal credentialing functions and complete “Dynamic Registration” with insurance, hospital, and other certified health IT system APIs in seconds. “Refresh tokens” associated with the API reduce both burden and cost by not asking the patient to redundantly enter their username and password. Apple Health and CMS Blue Button 2.0 have already demonstrated the utility of this feature of the current standards.

To enable the breakthrough of a cost-effective longitudinal patient record without imposing a government-run health records bureaucracy common in other rich economies, our regulators will also need to deal with the exploding number of patient and consumer portals. Fortunately, we have OAuth standards to deal with that as well. UMA (User Managed Access) on page 91 of the 2019 ONC Interoperability Standards Advisory is indirectly in the NPRM.

Thanks to bipartisan efforts to fix the frustrations and escalating costs of HITECH via the 21st Century Cures Act, and now the breakthrough regulation by HHS in this NPRM, we have light a the end of the Health IT tunnel.

Patients and patient designees as API Clients will use their power of the purse to revitalize and transform EHRs for both clinical and research uses. Now that a path to having data follow the patient is in hand, it will be critical that Medicare, VA, NIH All of Us, and the Office for Civil Rights follow through by example and by enforcement to empower patients as the foundation for a globally competitive US health care system.

Adrian Gropper, MD, is the CTO of Patient Privacy Rights, a national organization representing 10.3 million patients and among the foremost open data advocates in the country. This post originally appeared on the Petrie Flom Center’s Bill of Health here

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Running an RCT – A Conversation With the Investigators of the REGAIN Trial

By SAURABH JHA MD SAURABH JHA

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.

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THCB Spotlights: EyeforPharma

By ZOYA KHAN

Jessica DaMassa interviews Paul Simms, the Chairman of Eyepharma. 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. 

Eyeofphrama’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.

Zoya Khan is the Editor-in-Chief of The Health Care Blog and an Associate at SMACK.health

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