In January, I posted a list of 10 predictions for 2016 based on an aggregation of leading Health IT industry publications. Here is a mid-year update on three of the predictions that remain on track.
Prediction #1: Where market forces and self-policing by industry fail to keep costs and quality in line, government will step in to enact reforms. Drug costs, lab developed tests, mobile apps, and medical necessity are among the candidates for regulation.
The drama surrounding Theranos is the top story related to self-policing versus government regulation. The startup lab company’s promise to accurately perform hundreds of lab tests inexpensively and with just a tiny blood sample seemed revolutionary, but an investigation uncovered that the accuracy and applicability of the technology was below standards and jeopardized patient safety. The FDA and CMS stepped in to shut down the parts of Theranos that were noncompliant. Unfortunately, those were also the disruptive technologies that made the company an industry game changer.
In other regulatory news, the Senate’s MEDTECH Act aims to clarify which types of software and mobile apps will be classified as medical devices. If the bill becomes law, most types of software that are not related to processing medical images or signals will be exempt from the FDA regulation. This means that software developers will have clear guidance as to whether their designs, marketing and processes will need to meet the higher standards of quality and compliance required for a medical device. Removing the uncertainty will help take the risk out of building innovative, new applications.
Prediction #2: Security threats will continue to be a top priority for IT departments. New techniques and best practices will become more widespread to help reduce some threats.
The first half of 2016 was characterized by a high number of ransomware attacks on healthcare organizations.
As this graph from Google Trends shows, ransomware was a largely unrecognized threat before 2016. As a result, no source specifically predicted ransomware as a security threat; however, general security concerns appeared on the list of predictions.
Industry’s initial reaction to ransomware’s emergence has been the publication of reliable information in articles, whitepapers and webinars. Building awareness of a threat can help defend against it. Next, industry will need to develop tools and best practices for defending against threats such as ransomware. One promising initiative by Intermountain Healthcare is underway, but there is still a great deal of work to do before the threat is under control.
The use of Blockchain technology in healthcare is another concept that was barely on the radar before 2016. Of all the articles making predictions for the New Year, only Chilmark Research mentioned Blockchain. In the past six months, Blockchain has become a hot topic with industry leaders such as IBM and Philips announcing activity in this area.
Prediction #3: In 2016 vendors and IT departments must make significant advances [in interoperability] or face government intervention. Meaningful Use Stages 1 and 2 helped migrate a majority of medical records form paper to electronic format and established an interoperability baseline. To build on this momentum data needs to flow freely among systems.
MACRA emerged as CMS’ replacement – at least for providers – for the Sustainable Growth Rate (SGR) and Meaningful Use (MU) program, and interoperability remains a fundamental part of the package. Among other provisions, MACRA directs the ONC to measure the level of interoperability among healthcare stakeholders, prompting the agency an RFI to to solicit reponses on how this should be done. Dozens of organizations responded to the RFI, providing a broad set of suggestions for the ONC to work from.
The Meaningful Use program achieved a couple of objectives which may have seemed questionable at the time but are now starting to pay dividends. First, it established C-CDA as the standard format for exchanging patient data. Second, it required providers to allow patients to view, download and transmit their clinical records in C-CDA format. Now that the industry supports a common format and baseline functionality, we can begin innovating valuable solutions on this infrastructure.
As the practice of healthcare interoperability expands beyond clinical systems to include consumer devices and monitors, it’s important that the same standards apply across the board. Apple recently announced support for C-CDA in iOS 10’s Health Kit, which is an encouraging sign that the MU standards are taking hold in consumer devices.
Regulation, security and interoperability are just a few of the topics that made headlines in the first six months of the year. With the second half the year still ahead of us, there’s plenty of time to see how the rest of this year’s predictions unfold. In particular, Precision Medicine is becoming an active topic with several conferences scheduled in the coming months and funding for President Obama’s Precision Medicine Initiative in Congress’ hands.
Last week the ONC announced that 96% of hospitals had at least a basic EHR in place in 2015, which is up significantly from the 10% adoption rate in 2008. As an industry we’ve gone from practically no medical records stored electronically to virtually all of them in just 7 years. This growth rate is impressive, but it’s unfortunate that it took until 2008 and a $20 billion incentive from the federal government for widespread adoption to occur.
The impetus and source of funding for this rapid adoption is, of course, the HITECH Act, in which the federal government encouraged adoption by subsidizing EHR procurements.
Encouraging adoption is one of the four roles the Federal government has claimed with respect to Health IT, and doing so through direct stimulus is a straightforward approach. A financial incentive can motivate high-level behavior, but it’s much more difficult to ensure the newly adopted technology is used to its full potential. Government can only exert limited influence over the direction of technological change, which is one reason Bill Gates describes government as a “blunt instrument”.
The HITECH incentives provide a subsidy for hospitals to procure EHR technology, and the Meaningful Use standards set a minimum threshold for how the technology is to be used. But
the specific features and uses of the software are left up to the software developers and users to determine. This arrangement provides a constructive way to break the deadlock that had prevented adoption from occurring before 2008.
The blunt instrument of government funding began the process of EHR adoption so that a critical mass of electronic records became available to enable new and innovative ways to care for patients, but government incentives demonstrate their bluntness when it comes to anticipating and managing the implications – both good and bad – of a mostly electronic recordkeeping infrastructure.
Now that the preponderance of medical records is electronic, rather than paper, it’s possible to quickly exchange individual records, run reports and analytics across patient databases, and easily generate reportable statistics and metrics. These are the fundamental, operational building blocks required to optimize any system, and theONC’s Interoperability Roadmap describes how a technological infrastructure is key to what they call the Learning Health System.
Of course, there are also downsides to moving medical records from paper to databases in such a short time frame. One problem is a shortage of workers to accomplish the implementations. Another problem is that other aspects of Health IT are struggling to keep up with the rapid shift to electronic health records.
Cybersecurity is a particularly worrying part of the struggle. Electronic records are an attractive target for hackers, which was never a problem with paper-based records. IT departments experience difficulties providing sufficient privacy, security, and compliance for their new data asset. This is one reason that cybersecurity made the list of top HIT trends for 2016.
In spite of the risks and challenges, the Health IT industry is committed to a digital future. The path forward will be characterized by two major concerns: how to deal with the implications, such as security, of storing electronic health records; and how to best take advantage of the new, digital infrastructure to improve patients’ health and realize the Learning Health System.