Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

GOA to investigate FDA’s orphan drug program

The Government Accountability Office (GAO) has confirmed it will investigate the U.S. Food and Drug Administrations (FDA) Orphan Drug program following a letter from senators citing possible exploitation.

March 22, 2017
Medical device tax

Device, drug makers would pay $1 billion extra to FDA under Trump budget

Included in President Donald Trump’s budget proposal for fiscal year 2018 is a big increase in what the medical device and pharmaceutical industries would pay the Food and Drug Administration (FDA) to cover the costs of reviewing their products.

March 16, 2017

AHIMA releases guidelines for inclusion of LGBT patients

The American Health Information Management Association (AHIMA) has released a brief of guidelines for health information management professionals and clinicians on improving inclusion for patients in the LGBTQ community, covering multiple sexual orientations and gender identities.

March 14, 2017

AHIMA releases toolkit to assist in preparing for HIPAA audits

The American Health Information Management Association (AHIMA) has released its External HIPAA Audit Readiness Toolkit to assist organizations in preparing for the upcoming Health Insurance Portability and Accountability Act (HIPAA) Phase 2 audits. The toolkit includes Phase 2 aspects for covered entities, business associates and includes tips in meeting responsibilities.

March 2, 2017

HIMSS 2017: Four pillars of social media governance

In healthcare, social media is a much more serious affair than a few tweets and Instagram posts. The governance of such activity in healthcare is crucial in the protection of patient data and compliance with HIPAA. Nelly Jacobo, director of digital strategy at Cedars-Sinai, and Melody Smith Jones, manager of Connected Health at Perficient, discussed the four pillars of social media governance at HIMSS 2017.

February 20, 2017

Lawyers prompt for medical device failure reporting

Technology is prone to breaking from time to time but when the technology within a medical device fails, lives are at risk. Parker Waichman LLP, a law firm protecting patients injured by medical devices, have commented on the safety concerns involving morcellators and duodenoscopes. These comments ask regulators to enforce reporting of medical devices injuries.

February 17, 2017

SpectraMedix introduces National MACRA Advisory Council

SpectraMedix, a company specializing in transitioning hospitals to to value-based payment models, has developed a national advisory council dealing with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). This council, made up of healthcare policy and IT experts, will assist the industry implement Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) tracks.

February 15, 2017

Retired Navy commander appointed info security chief of HHS

HHS has appointed Christopher Wlaschin, a retired Navy commander, as its new chief information security officer.

January 31, 2017

Around the web

U.S. health systems are increasingly leveraging digital health to conduct their operations, but how health systems are using digital health in their strategies can vary widely.

When human counselors are unavailable to provide work-based wellness coaching, robots can substitute—as long as the workers are comfortable with emerging technologies and the machines aren’t overly humanlike.

A vendor that supplies EHR software to public health agencies is partnering with a health-tech startup in the cloud-communications space to equip state and local governments for managing their response to the COVID-19 crisis.

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