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Tag: 21st Century Cures Act

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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Remembering the Real Stakeholders: Patient Privacy Rights Comments on the Proposed CMS Regulation Pursuant to the Cures Act

Deborah C. Peele
Adrian Gropper

By ADRIAN GROPPER, MD and DEBORAH C. PEEL, MD

Electronic health records (EHRs) are a polarizing issue in health reform. In their current form, they are frustrating to many physicians and have failed to support cost improvements. The current round of federal intervention is proposed rulemaking pursuant to the 21st Century Cures Act calls for penalties for “information blocking” and for technology that physicians and patients could use “without special effort.”

The proposed rules are over one thousand pages of technical jargon that aims to govern how one machine communicates with another when the content of the communication is personal and very valuable information about an individual. Healthcare is a challenging and unique industry when it comes to interoperability. Hospitals spend lavishly on EHRs and pursue information blocking as a means to manipulate the physicians and patients who might otherwise bypass the hospital on the way to health reform. The result is a broken market where physicians and patients directly control trillions of dollars in spending but have virtually zero market power over the technology that hospitals and payers operate as information brokers.

What follows below are comments by Patient Privacy Rights on the proposed rule. The common thread of our comments is the need to treat patients and physicians, not the data brokers, as the real stakeholders.

Comments to the ONC Rule

Overview: 21st Century health care innovation, policy, and practice is increasingly dependent on personal information. This is obvious with respect to machine learning and risk adjustment, but personal information is now central to the competitive strategy for most of the health care economy, clinical as well as research. ONC’s drafting of this rule reflects the importance of competition to innovation and cost containment.

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Our Guide to Pre-Approval Access to Drugs For Both Doctors & Patients

By ALISON-BATEMAN HOUSE

In April 2016, I published guidance, in the form of a mock case study, on how to access a drug before it has been approved by the FDA—what’s known as pre-approval (or expanded or compassionate) access. This is an updated version of that guidance, reflecting multiple important changes in the pre-approval landscape over the past year. In particular, the FDA rolled out a new, streamlined form for single-patient requests, and Congress passed the 21st Century Cures Act, which, among many other things, mandated that certain pharmaceutical companies provide public information about their pre-approval access policies.

Patients (and physicians) trying to access an unapproved drug outside of a clinical trial can feel as though they’re navigating uncharted waters. Many physicians don’t know that the FDA permits the use of unapproved drugs outside of clinical trials; those who do know often have no idea how to access such drugs for their patients. Those physicians who know about pre-approval access are largely specialists in certain areas—often, oncology or rare diseases—and they are generally self-taught: they didn’t learn about pre-approval access in medical school or in their residencies. Thus, while some physicians have become very accustomed to requesting pre-approval access to drugs, the majority lacks this knowledge. In this essay, I use a fictional case to trace the process for requesting access to an unapproved drug. I hope to explode several myths about the process, especially the beliefs that the FDA is the primary decision-maker in granting access to unapproved drugs and that physicians must spend 100 hours or more completing pre-approval access paperwork.

Imagine you are a physician, and you have a pregnant patient who has tested positive for the Zika virus. She is only mildly ill, but she’s terrified that the virus, which has been linked with microcephaly and other abnormalities, will harm her unborn child. She’s so concerned that she is contemplating an abortion, even though she and her husband have been trying to have a child and were overjoyed to learn she was pregnant.

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Proposed Drug and Device Laws Should Be Pushed to 2017

flying cadeuciiSenate leaders now say they won’t consider companion legislation to the House-passed 21st Century Cures Act until September, after months of delay.  Lawmakers would then have to reconcile the differing House and Senate versions, presumably by year’s end during a lame-duck Congress.

We believe the summer delay is a good thing, and that Congress should actually extend consideration of the complex legislation into 2017 when must-pass FDA funding through industry user-fees will be on the congressional calendar.   That way, lawmakers can debate the implications of the proposed bills in the context of the resources FDA needs.

Why further delay?  Because the legislation—which makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices—is flawed.  As currently crafted, it lowers standards for drug and device approvals and safety, and risks adding to the rising cost of prescription drugs.
The ostensible rationale for the legislation—being pushed by drug and device companies—is that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared with other countries.

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