Developments and Trends in Digital Health, eHealth and Health IT
The UK’s National Institute for Health and Care Excellence (NICE) has recently published an evidence standards framework for DHTs (the Standards), available here. It did so through a working group led by NHS England, but supported by representatives from Public Health England, MedCity and DigitalHealth.London.
The Standards cover DHTs, such as apps, programs and…
On the April 25, 2018 the European Commission (the “Commission”) adopted a plan of action to enable the digital transformation of health and care in the Digital Single Market (the “Communication”), intended to put EU citizens at the centre of the healthcare system. This is to be achieved in three ways:
1. Citizens’ secure access to and sharing of health data
The Commission wishes to ensure that EU citizens should have secure access, anywhere in the EU, to a comprehensive electronic record of their health data. Citizens should remain in control of their health data (wherever it is located) and be able to share it securely with others for purposes chosen by those citizens, for example, medical treatment or research.
The Commission recommends the:
Continue Reading Summary of the European Commission’s eHealth Strategy
On March 6, 2018, CMS announced the MyHealthEData initiative, which aims to give patients easier access to and control over their medical records.
Announcing the initiative, CMS Administrator Seema Verma laid out a future where individuals will have access to their health data wherever they go and be able to share data with the push of a button, with easy access to their entire medical history from birth, including data from health visits, claims, and information gathered through wearable technology.
According to Administrator Verma’s speech and a CMS announcement, the MyHealthEData program is a government-wide initiative that includes the following components:Continue Reading CMS Announces MyHealthEData Initiative to Promote Patient Access to Health Data
As 2018 gets underway, EHR vendors and users continue to face challenges and uncertainty. There are three legal and regulatory issues in particular that we think are important to watch over the next 10 months:
Continue Reading Three EHR Issues to Watch in 2018
Technology companies widely use open source software (“OSS”), which carries with it many potential benefits. It can reduce the time and cost of development, and, to the extent that the code has been vetted by numerous other developers, may contain fewer bugs. OSS can also reduce dependency upon third party vendors and associated pricing risks.
In the healthcare space in particular, OSS has been cited as one potential way to reduce the cost of developing and delivering digital care solutions, which in turn may mean improved access to or quality of treatment for underserved populations.[1] And indeed, OSS is frequently used in healthcare IT. In fact, the EHR system for veterans, VistA, is available as open source code[2] and now deployed by a range of healthcare organizations.[3]
Of course, as with any third party technology, when incorporating OSS into a technology, it is important to carefully consider the soundness and security of the OSS code, as well as the legal terms on which the code is made available. Below we highlight some key considerations for digital health ventures that either currently do or wish to use OSS for their technology: (1) security, (2) how license terms may impact the ability to commercialize the technology, and (3) how the use of OSS may impact corporate transactions, such as mergers and acquisitions.Continue Reading Open Source Considerations for Digital Health Ventures
The full Senate could vote as early as this week on the nomination of Rep. Tom Price (R-GA) to be Secretary of the U.S. Department of Health and Human Services (HHS). In January, two Senate Committees held hearings on Rep. Price’s nomination. These hearings focused largely on Rep. Price’s stance on repeal of the Affordable Care Act (ACA) and on reform of the Medicare and Medicaid programs. Senators asked few questions related to health information technology, and the limited discussion on this topic centered primarily on the burdens placed on providers by HHS initiatives to promote the “meaningful use” of electronic health records (EHRs).
Continue Reading Vote on HHS Secretary Nomination Expected as Early as this Week; Nomination Hearings Included Little Discussion of Health IT
Tom Price, the Republican representative from Georgia, has been tapped by President-elect Trump as the new Secretary for the Department of Health and Human Services (HHS). Rep. Price is himself an orthopedic surgeon and comes from a family of doctors and, as a result, is focused closely on the ways in which government regulations burden the doctor-patient relationship. At an American Enterprise Institute event this past June, Rep. Price criticized the Affordable Care Act for allowing the government, rather than doctors and patients, to control the manner in which healthcare is offered.
Continue Reading Incoming HHS Secretary Tom Price Brings Physician-Focused Perspective to Health IT
Last month, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) released a new guide for prospective buyers of Electronic Health Record systems (EHRs). ONC provides detailed information and suggestions that merit the serious consideration of anyone that contracts or plans to contract with an EHR vendor.
ONC begins with a broad introduction that explains what kinds of options exist and offers advice on how to select an appropriate system. Then, ONC provides detailed advice on a number of important topics, including safety and security, system performance, data rights, interoperability, IP, risk management, dispute resolution, and transitions. For each of these topics, ONC identifies common pitfalls and provides buyer friendly form contract language. Sprinkled throughout the guide are descriptions of common pitfalls and advice about how to avoid them. Some of these points are worth further emphasis.
ONC notes that some buyers have complained about inconsistencies between vendor demonstrations and their actual products. It is important to remember that marketing materials and demonstrations are not necessarily reliable. ONC suggests requiring that any such materials presented to a buyer be attached and incorporated into the final EHR contract. Furthermore, core service and performance obligations should be memorialized with express warranties. This should provide some security against falling victim to a bait and switch.Continue Reading ONC Releases New Guide on Buying EHR
Earlier this week the Government Accountability Office released a report critiquing the U.S. Department of Health and Humana Services’ (HHS) oversight of and guidance related to health information security and privacy. (The report is available here.)
GAO cited the increasing incidence of hacking and other breaches, which affected over 113 million health records in 2015, as a key reason to ensure that HHS provides appropriate guidance to and oversight of covered entities and business associates. Hacking and other breaches may result in identify theft, fraud, disruption of health care services, and even national security threats.
GAO’s concerns fell into two primary categories: those related to HHS’s guidance to covered entities and business associates, and those related to oversight efforts.
Continue Reading GAO Recommends that HHS Strengthen Privacy and Security Guidance and Oversight
Last month, the Office of Management and Budget (“OMB”) began its review of the much-discussed new Health IT Certification regulations, which include enhanced oversight of Electronic Health Records (“EHRs”) technology by the Office of the National Coordinator for Health Information Technology (“ONC”).
Continue Reading OMB Reviewing Final Health IT Certification Regulations
