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Tag: HIPAA

ACCESS Act Points the Way to a Post-HIPAA World

By ADRIAN GROPPER, MD

The Oct. 22 announcement starts with: “U.S. Sens. Mark R. Warner (D-VA), Josh Hawley (R-MO) and Richard Blumenthal (D-CT) will introduce the Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act, bipartisan legislation that will encourage market-based competition to dominant social media platforms by requiring the largest companies to make user data portable – and their services interoperable – with other platforms, and to allow users to designate a trusted third-party service to manage their privacy and account settings, if they so choose.”

Although the scope of this bill is limited to the largest of the data brokers (messaging, multimedia sharing, and social networking) that currently mediate between us as individuals, it contains groundbreaking provisions for delegation by users that is a road map to privacy regulations in general for the 21st Century.

The bill’s Section 5: Delegation describes a new right for us as data subjects at the mercy of the institutions we are effectively forced to use. This is the right to choose and delegate authority to a third-party agent that can manage interactions with the institutions on our behalf. The third-party agent can be anyone we choose subject to their registration with the Federal Trade Commission. This right to digital representation by an entity of our choice with access to the full range of our direct control capabilities is unprecedented, as far as I know.

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Patient Controlled Health Data: Balancing Regulated Protections with Patient Autonomy

By KENNETH D. MANDL, MD, MPH, DAN GOTTLIEB, MPA, and JOSHUA MANDEL, MD

This piece is part of the series “The Health Data Goldilocks Dilemma: Sharing? Privacy? Both?” which explores whether it’s possible to advance interoperability while maintaining privacy. Check out other pieces in the series here.

A patient can, under the Health Insurance Portability and Accountability Act (HIPAA), request a copy of her medical records in a “form and format” of her choice “if it is readily producible.” However, patient advocates have long complained about a process which is onerous, inefficient, at times expensive, and almost always on paper. The patient-driven healthcare movement advocates for turnkey electronic provisioning of medical record data to improve care and accelerate cures.

There is recent progress. The 21st Century Cures Act requires that certified health information technology provide access to all data elements of a patient’s record, via published digital connection points, known as application programming interfaces (APIs), that enable healthcare information “to be accessed, exchanged, and used without special effort.”  The Office of the National Coordinator of Health Information Technology (ONC) has proposed a rule that will facilitate a standard way for any patient to connect an app of her choice to her provider’s electronic health record (EHR).  With these easily added or deleted (“substitutable”) apps, she should be able to obtain a copy of her data, share it with health care providers and apps that help her make decisions and navigate her care journeys, or contribute data to research. Because the rule mandates the ”SMART on FHIR” API (an open standard for launching apps now part of the Fast Healthcare Interoperability Resources ANSI Standard), these apps will run anywhere in the health system.

Apple recently advanced an apps-based information economy, by connecting its native “Health app” via SMART on FHIR, to hundreds of health systems, so patients can download copies of their data to their iPhones. The impending rule will no doubt spark the development of a substantial number of additional apps.

Policymakers are grappling with concerns that data crossing the API and leaving a HIPAA covered entity are no longer governed by HIPAA. Instead, consumer apps and the data therein fall under oversight of the Federal Trade Commission (FTC). When a patient obtains her data via an app, she will likely have agreed to the terms and the privacy policy for that app, or at least clicked through an agreement no matter how lengthy or opaque the language.  For commercial apps in particular, these are often poorly protective. As with consumer behavior in the non-healthcare apps and services marketplace, we expect that many patients will broadly share their data with apps, unwittingly giving up control over the uses of those data by third parties.

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Protecting Health Data Outside of HIPAA: Will the Protecting Personal Health Data Act Tame the Wild West ?

Vince Kuraitis
Deven McGraw

By DEVEN McGRAW and VINCE KURAITIS

This post is part of the series “The Health Data Goldilocks Dilemma: Privacy? Sharing? Both?”

Introduction

In our previous post, we described the “Wild West of Unprotected Health Data.” Will the cavalry arrive to protect the vast quantities of your personal health data that are broadly unprotected from sharing and use by third parties?

Congress is seriously considering legislation to better protect the privacy of consumers’ personal data, given the patchwork of existing privacy protections. For the most part, the bills, while they may cover some health data, are not focused just on health data – with one exception: the “Protecting Personal Health Data Act” (S.1842), introduced by Senators Klobuchar and Murkowski. 

In this series, we committed to looking across all of the various privacy bills pending in Congress and identifying trends, commonalities, and differences in their approaches. But we think this bill, because of its exclusive health focus, deserves its own post. Concerns about health privacy outside of HIPAA are receiving increased attention in light of the push for interoperability, which makes this bill both timely and potentially worth of your attention.

HHS and ONC recently issued a Notice of Proposed Rulemaking (NPRM) to Improve the Interoperability of Health Information. This proposed rule has received over 2,000 comments, many of which raised significant issues about how the rule potentially conflicts with patient and provider needs for data privacy and security.

For example, greater interoperability with patients means that even more medical and claims data will flow outside of HIPAA to the “Wild West.” The American Medical Association noted:

“If patients access their health data—some of which could contain family history and could be sensitive—through a smartphone, they must have a clear understanding of the potential uses of that data by app developers. Most patients will not be aware of who has access to their medical information, how and why they received it, and how it is being used (for example, an app may collect or use information for its own purposes, such as an insurer using health information to limit/exclude coverage for certain services, or may sell information to clients such as to an employer or a landlord). The downstream consequences of data being used in this way may ultimately erode a patient’s privacy and willingness to disclose information to his or her physician.”

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Health Data Outside HIPAA: The Wild West of Unprotected Personal Data

Deven McGraw
Vince Kuraitis

By VINCE KURAITIS and DEVEN McGRAW

This post is part of the series “The Health Data Goldilocks Dilemma: Privacy? Sharing? Both?”

“…the average patient will, in his or her lifetime, generate about 2,750 times more data related to social and environmental influences than to clinical factors”

McKinsey analysis

The McKinsey “2,750 times” statistic is a pretty good proxy for the amount of your personal health data that is NOT protected by HIPAA and currently is broadly unprotected from sharing and use by third parties.

However, there is bipartisan legislation in front of Congress that offers expanded privacy protection for your personal health data. Senators Klobuchar & Murkowski have introduced the “Protecting Personal Health Data Act” (S.1842). The Act would extend protection to much personal health data that is currently not already protected by HIPAA (the Health Insurance Portability and Accountability Act of 1996). 

In this essay, we will look in the rear-view mirror to see how HIPAA has provided substantial protections for personal clinical data — but with boundaries. We’ll also take a look out the windshield — the Wild West of unprotected health data.

Then in a separate post, we’ll describe and comment on the pending “Protect Personal Health Data Act”.

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A National Patient Identifier: Should You Care?

By ADRIAN GROPPER, MD

The rather esoteric issue of a national patient identifier has come to light as a difference between two major heath care bills making their way through the House and the Senate.

The bills are linked to outrage over surprise medical bills but they have major implications over how the underlying health care costs will be controlled through competitive insurance and regulatory price-setting schemes. This Brookings comment to the Senate HELP Committee bill summarizes some of the issues.

Who Cares?

Those in favor of a national patient identifier are mostly hospitals and data brokers, along with their suppliers. More support is discussed here. The opposition is mostly on the basis of privacyand libertarian perspective. A more general opposition discussion of the Senate bill is here.

Although obscure, national patient identifier standards can help clarify the role of government in the debate over how to reduce the unusual health care costs and disparities in the U.S. system. What follows is a brief analysis of the complexities of patient identifiers and their role relative to health records and health policy.

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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.

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HIPAA RFI Comments: Patient Privacy Rights

By ADRIAN GROPPER and DEBORAH C. PEEL

Adrian Gropper

Deborah C. Peele

Among other rich nations, US healthcare stands out as both exceptionally privatized and exceptionally expensive. And taken overall, we have the worst health outcomes among the Western Democracies.

On one hand, regulators are reluctant to limit private corporate action lest we reduce innovation and patient choice and promote moral hazards. On the other hand, a privatized marketplace for services requires transparency of costs and quality and a minimum of economic externalities that privatize profit and socialize costs.

For over two decades, the HIPAA law and regulations have dominated the way personal health data is used and abused to manipulate physician practice and increase costs. During these decades, digital technology has brought marvels of innovation and competition to markets as diverse as travel and publishing while healthcare technology is burning out physicians and driving patients to bankruptcy.

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Hoarding Patient Data is a Lousy Business Strategy: 7 Reasons Why

By VINCE KURAITIS & LESLIE KELLY HALL

Vince Kuraitis

Leslie Kelly Hall

Among many healthcare providers, it’s been long-standing conventional wisdom (CW) that hoarding patient data is an effective business strategy to lock-in patients — “He who holds the data, wins”. However…we’ve never seen any evidence that this actually works…have you?

We’re here to challenge CW. In this article we’ll explore the rationale of “hoarding as business strategy”, review evidence suggesting it’s still prevalent, and suggest 7 reasons why we believe it’s a lousy business strategy:

  1. Data Hoarding Doesn’t Work — It Doesn’t Lock-In Patients or Build Affinity
  2. Convenience is King in Patient Selection of Providers
  3. Loyalty is Declining, Shopping is Increasing
  4. Providers Have a Decreasingly Small “Share” of Patient Data
  5. Providers Don’t Want to Become a Lightning Rod in the “Techlash” Backlash
  6. Hoarding Works Against Public Policy and the Law
  7. Providers, Don’t Fly Blind with Value-Based Care

Background

In the video below, Dr. Harlan Krumholz of Yale University School of Medicine capsulizes the rationale of hoarding as business strategy.

We encourage you to take a minute to listen to Dr. Krumholz, but if you’re in a hurry we’ve abstracted the most relevant portions of his comments:

“The leader of a very major healthcare system said this to me confidentially on the phone… ‘why would we want to make it easy for people to get their health data…we want to keep the patients with us so why wouldn’t we want to make it just a little more difficult for them to leave.’ …I couldn’t believe it a physician health care provider professional explaining to me the philosophy of that health system.”

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Ensuring that the 21st Century Cures Act Health IT Provisions Promotes Interoperability and Data Exchange

By KENNETH D. MANDL, MD; DAN GOTTLIEB;
JOSH C. MANDEL, MD

Josh Mandel

Kenneth Mandl

Dan Gottlieb

The opportunity has never been greater to, at long last, develop a flourishing health information economy based on apps which have full access to health system data–for both patients and populations–and liquid data that travels to where it is needed for care, management and population and public health. A provision in the 21st Century Cures Act could transform how patients and providers use health information technology. The 2016 law requires that certified health information technology products have an application programming interface (API) that allows health information to be accessed, exchanged, and used “without special effort” and that provides “access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws.”

After nearly two years of regulatory work, an important rule on this issue is now pending at the Office of Management and Budget (OMB), typically a late stop before a proposed rule is issued for public comment. It is our hope that this rule will contain provisions to create capabilities for patients to obtain complete copies of their EHR data and for providers and patients to easily integrate apps (web, iOS and Android) with EHRs and other clinical systems.

Modern software systems use APIs to interact with each other and exchange data. APIs are fundamental to software made familiar to all consumers by Google, Apple, Microsoft, Facebook, and Amazon. APIs could also offer turnkey access to population health data in a standard format, and interoperable approaches to exchange and aggregate data across sites of care.

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Michelle Longmire, CEO Medable

I never ceased to be amazed by how smart young clinicians solve problems that they see. Michelle Longmire was in residency at Stanford working with colleagues building point solutions when she realized that what they needed was an easy platform on which to develop medical grade apps. Her company Medable was the result. Then she realized that the other big market was clinical researchers, who now have access to Apple’s ResearchKit, but need an easy way to build a study without using developers. I interviewed her recently and she built a study for me using Medable’s new Axon product.

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