Tuesday, 30 June 2020

generic.com

Today, the Supreme Court ruled (8-1) that merely adding ".com" to a generic term may allow the combination to be protected as a non-generic trademark. In other words, adding ".com" can confer meaning to the consuming public, and thus is not the same as adding "company" or "inc," which does not confer meaning. That was really the linguistic question in the case. Case law has long held that "Booking, Inc." is really "Booking." So, is "Booking.com" also "Booking"? Or is it "Booking.com"?

As a reminder, a mark is generic when it describes what the product is, and not who makes the product. So, Booking.com would refer to a single company (who) that makes bookings, and not to just any booking company (what). A generic term might be lawyer - it refers to what (legal services) and not to who (there are many lawyers). As the Court puts it, Travelocity is a booking company, but is it a booking.com company?

I signed on to an amicus brief supporting Booking.com, and I'll tell a story why (and why I so keenly followed this case). Way back in the beginning of the commercial internet, my firm registered the domain computerlaw.com. This was a big deal - making it work for email required complicated email gateways, etc. I hadn't even gone to law school yet, and I was in charge of setting it up. Connectivity looked a lot different for a small firm in 1994 than it does now.

We were proud of this, and we used the domain as a mark - put it right on the letterhead "computerlaw.com." In 1995, we filed for a California trademark registration, and received pushback much like the PTO. Our response was that adding .com meant something - that we were wired, connected no less. We pointed out that a big commercial of the time advertised "Nasdaq......dot com" in an effort to show how the Nasdaq was wired. We were successful - California registered the mark and it is valid to this day.

So, in 2000, after five years of use (which we believed would give us a presumption of secondary meaning), we filed with the U.S. PTO. The Trademark Office sat on the application for nearly three years, before finally rejecting the mark as generic, sending us a Google search of many people referring to "computer law." We argued that first, computerlaw is different from computer law, and second, that the ".com" means something. We argued to no avail - the examiner stated that the domain name rendered the elimination of the space meaningless, and also ignored the .com as if it weren't there. The killer was the generic finding (as opposed to merely descriptive), because we couldn't even gather evidence of secondary meaning of the mark, with or without the .com.

I wanted to fight this ruling, but I was sadly outvoted. But now the firm is ready to file again - Booking.com fought the battle instead, only some fifteen years later.

And so, the Court ruled that consumer perception controls whether a mark such as BOOKING.COM or COMPUTERLAW.COM is a what or a who, and we don't ask whether BOOKING or COMPUTER LAW is the what or who.

Justice Breyer wrote a dissent for his single vote to the contrary. In his view, there are times when consumer perception might associate a name with a product, but the name is generic anyway. He cites Kellogg Co. v. National Biscuit Co., 305 U.S. 111 (1938) for this proposition. In that case, Nabisco had used "shredded wheat" exclusively for a number of years while a patent on the cereal was in force. After patent expiration, Kellogg wanted to use the mark, and the Court agreed that Kellogg's could - shredded wheat was what had been patented, and as a result Nabisco could not claim exclusive ownership even if people before that time had only associated shredded wheat with Nabisco.

I don't see Justice Breyer's concern as fundamentally at odds with the majority's preference for consumer perception. The Court did not rule that the mark was automatically nongeneric - that's a question of fact. Just as any apparently non-generic term might be deemed generic, so too might the same term with a .com attached to it. There's no reason why booking.com should get more or less consideration than shredded wheat got. Indeed, this one sentence says it all: "True, few would call Travelocity a 'Booking.com.'" QED. That's the definition of what it means to be generic. People did call the cereal "shredded wheat," because that's what it was.

It is in the examples used to avoid this conclusion that Justice Breyer loses me. 
-"Just as 'Wine Company' expresses the generic concept of a company that deals in wine, 'wine.com' connotes only a website that does the same."  Well, yes, but it connotes one particular website - and no other website with that name - that does the same. I've always called this the Highlander rule of domain name trademarks - there can be only one.

-"The meaning conveyed by 'Booking.com' is no more and no less than a website associated with its generic second-level domain, 'booking.'" Well, yes, but there is only one website, and it advertises itself so consumers know to go there instead of other booking sites that have different names.

-Justice Breyer points to the fact that 33% of survey takers thought "washingmachine.com" (a fake domain) was distinctive while the rest thought it was generic. Justice Breyer thought this was evidence of a problem, but I take it as evidence that ".com" means something - when you have the domain, you're the only one using it to sell stuff. There is no way that survey takers suddenly thought "washing machine" was distinctive.

-"Still, the term 'Wine, Inc.' is generic because it signifies only a company incorporated for that purpose." This is the big issue - is .com the same as "Inc." or "Co."? I think not for the same reason the majority states - domain names are unique. But more broadly, it may be that the Inc. becomes part of a distinctive name such that consumers can distinguish the Wine Company from any Wine Company.  And then the Supreme Court precedent on this would have to be overruled (maybe - a search of "Company" in TESS yields more than 50,000 results). In any event, the Court dodged the question today. In my mind, the primary problem with corporate designations is that multiple companies can use the generic word plus "incorporated" in 50 different states. Even if only one of them becomes well enough known to be distinctive, it limits the amount of words available to other companies, and might allow for the first to reach distinctiveness to lock-out the other 49 companies with the same generic name.

Thus, the bigger concern, I think, is that owners of now distinctive domain name marks might now enforce against those not using the domain name to limit generic word usage. Can booking.com sue a company using the slogan "Booking Bonanza"? I think probably not. Can "WashingMachine.com" sue Home Depot for sale of washing machines? No. The domain name mark will necessarily be narrow, especially if it is a generic.com. It may seem unfair that the first to a generic.com domain name is able to get trademark rights, but such was life on the internet in the 1990s. But that should not be compounded by enforcing generic words against others - only that others cannot use the domain name mark in an infringing way.

Which leads to the last question - what about Booking.info, Booking.biz, etc.? I think these are fair game for competitors. Live by the uniqueness, die by the uniqueness. (Booking.com bought those two domains, by the way.) This might also apply to foreign domains. At my firm, we routinely got email intended for computerlaw.com.au - an Australian law firm that took computer cases. 

The whole opinion is an interesting read. We'll see whether the dot-com trademark registration boom occurs, or whether the marks are too narrow to generate significant value.

Read more »

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Wednesday, 24 June 2020

How can health regulators maintain public trust when facing scientific uncertainty?


Health regulators such as the FDA and CDC always operate under uncertainty—evidence about health interventions inevitably comes with error bars. Under normal circumstances, regulators demand evidence that meets certain thresholds of validity and reliability before taking action, such as making a public health recommendation or approving a new drug. During a public health emergency like the COVID-19 pandemic, regulators are forced to act under higher-than-usual uncertainty: the social costs of waiting for better evidence often outweigh the costs of taking action before all the evidence is in. Regulators will thus make more mistakes than usual. And in addition to the direct costs of these mistakes, apparent flip-flopping on regulatory decisions risks undermining public trust in health agencies. In this post, we provide some examples of regulators reversing COVID-19-related decisions, describe the considerations these agencies are attempting to balance, and suggest ways for health regulators to maintain public trust while acting under high scientific uncertainty.

Where have regulators changed their decisions related to COVID-19?

In the last few months, regulators have made striking reversals in three areas: the wearing of masks by the public, the emergency use authorization (EUA) of hydroxychloroquine and chloroquine, and the EUA for the diagnostic company Chembio’s COVID-19 antibody testing.

One high-profile reversal addresses whether the general public should wear masks. As we have described, N95 masks do a good job protecting the wearer from the virus; other masks don’t protect the wearer as well, but reduce the chance that an infected wearer will spread the virus to others. In the early days of the pandemic, public health officials, including at the CDC, were understandably concerned about shortages of PPE, including N95 masks, for health-care workers. To curtail panic-buying and hoarding, and relying on equivocal evidence about mask protectiveness, the CDC recommended in February that members of the public not buy or wear masks. The Surgeon General tweeted, “Seriously people- STOP BUYING MASKS! They are NOT effective in preventing general public from catching #Coronavirus, but if healthcare providers can’t get them to care for sick patients, it puts them and our communities at risk!” On April 3, the CDC changed course and recommended that the general public wear cloth masks to reduce transmission. As of today, eighteen states (including DC) have statewide mask mandates for the general public, and most others have partial mandates; Iowa, Montana, Wisconsin, and South Dakota are currently the only states with no mask requirement.

Almost as striking is the FDA’s revocation of the EUA for hydroxychloroquine and chloroquine (jointly, HCQ) to treat COVID-19. An EUA may be granted in emergency situations to authorize the use of a product that, while not supported by enough evidence to be cleared or approved, “may be effective” in treating, preventing, or diagnosing a disease. President Trump repeatedly touted the benefits of HCQ before the EUA was granted, leading to speculation that political reasons were involved in the FDA’s March 28 issuance of the EUA. As HCQ use increased, and along with it studies of the drug’s effects, safety and efficacy questions arose. On April 24, the FDA cautioned against use of the drug outside hospitals or clinical trials due to the risk of serious heart problems. And on June 15, the FDA revoked the EUA.

As a third example, on June 16, the FDA revoked the EUA for Chembio’s SARS-CoV-2 antibody test. We explained in a previous post that antibody tests—which determine whether someone has been infected in the past—were initially subject to little regulatory oversight, but that in early May the agency began to increase its scrutiny, including by requiring companies to apply for EUAs. Chembio was one of 10 manufacturers and laboratories that received an EUA before May, but the FDA states that it has now revoked this EUA based on two new pieces of information. First, the FDA learned more about the test itself; in addition to the performance data supplied by Chembio, the FDA received data from the National Cancer Institute’s independent evaluation of the test (among many others). Second, the FDA’s increased experience with the many COVID-19 antibody tests on the market has led it to develop general performance expectations, based both on how well existing tests can perform and on “what performance is necessary for users to make well-informed decisions.” Apparently, the new data on Chembio’s test fell short of FDA’s new standard. As of June 17, the test is still authorized in Europe and Brazil.

What kinds of considerations are regulators balancing under these circumstances?

In these situations, regulators are dealing with at least three types of challenges. The first is scientific uncertainty. Although there is always some degree of scientific uncertainty in the regulation and approval of new healthcare technologies, in emergency situations like this one, regulators need to make decisions earlier in the scientific process of understanding a new technology. In the midst of skyrocketing COVID-19 cases and widespread PPE shortages, the CDC could not wait for the best evidence on masks before making some public recommendation. And the FDA is being asked to authorize the use of prescription drugs or diagnostic tests on evidence that would not be sufficient for full approval of the products, and which is often of lower quality (such as when a clinical trial is not randomized). Like all of us, the government is also constantly learning more about the novel coronavirus, such that the FDA may update its performance expectations for diagnostic tests over time.

Second, regulators must consider the right balance of Type I and Type II errors in their regulatory decisions. That is, one possibility is for the FDA to minimize the number of unsafe or ineffective drugs it approves (Type I errors), for fear of harming patients and jeopardizing the public trust in the agency. But another possibility is for the agency to minimize the number of safe, effective drugs it fails to approve (Type II errors), because doing so would deny patients access to a drug which is actually safe and effective. When focusing on this patient access perspective, economists have argued that the FDA is often too conservative in approving new drugs for particularly deadly conditions. These same considerations might weigh in favor of the agency taking rapid action to authorize the use of new products—like HCQ or antibody testing—for a condition wreaking havoc around the globe. However, the negative coverage of the agency for its decisions on both fronts means that the agency already has two strikes against it, from the public’s perspective. The FDA thus may be especially cautious when it comes to the authorization of a vaccine candidate.

Third, the negative coverage of reversed decisions highlights the need for regulators to maintain the public trust. As Professor Dan Carpenter has written in his seminal book on the FDA, the agency’s reputation and public image as an organization committed to consumer safety has cemented public trust in the agency. The agency would be jeopardizing existing high levels of trust if it made too many decisions about which it later changed its mind. In the context of the pandemic, it is especially critical that the public trusts that any vaccine the FDA authorizes or approves is both safe and effective for its intended use. This task is made more difficult in light of reporting that the administration may pressure the FDA to authorize or approve a vaccine before the election. Similarly, the CDC’s mixed messaging on the use of masks created a contradiction that may have increased mistrust in the agency. Health regulators cannot simply assume widespread compliance with their recommendations and focus on maximizing health impact; they also need to consider how to maintain public trust.

How can health regulators maintain public trust under these circumstances?

Even with a host of empirical unknowns, agencies and policymakers have several strategies to better incorporate public trust concerns into these decisions, including being clearer about the evidentiary support for decisions and how those decisions will be updated in light of new evidence; recognizing the particular perils that Type I errors raise for public trust; and learning from their international counterparts.

First, regulators should be more explicit about both the level of uncertainty at the time a decision is made and how regulatory decisions will be updated as more data come in. Agencies should make clear that reversing decisions in light of new data is part and parcel of, not an exception to, administrative business. Communicating about uncertainty on the front end includes, for example, publicly explaining the differences between words like “authorized,” “approved,” or “cleared,”—shibboleths of FDA practitioners that turn, in large part, on differences in evidence of safety and effectiveness.

To help clarify policies for reversing decisions on the back end, regulators should consider using precommitment mechanisms to specify why authorization decisions might be reversed. The initial EUA for HCQ, for example, could have stated that it was based on limited evidence from observational studies and would be withdrawn if the randomized trials that were underway failed to achieve certain results (as they did). If randomized trials were not currently underway, the agency could have precommitted to withdrawing the EUA under clearly defined circumstances, such as a failure to show a benefit from a clinical trial meeting certain conditions. Separately, establishing procedures for how the agency is to assess previously unanticipated data should shield agencies from criticisms that they lack “clear policy” on “unanswered scientific questions of utility and accuracy.” Fortunately, for the FDA, this is already baked into the EUA statute; the agency has broad leeway to revoke EUAs that may no longer be effective or safe “based on the totality of scientific evidence.” But this has yet to lead the agency to release guidelines calibrating “what constitutes the totality of scientific evidence” on both the front end—authorization—and back—withdrawal—as the pandemic continues.

Second—and instructive in the antibody testing case—regulators should recognize that some errors have a greater potential to undermine public trust than others. If the FDA approves or authorizes a drug which turns out to be unsafe or ineffective (a Type I error), this is more likely to be discovered—and to serve as an arrow of mistrust of the agency. Drugs and devices erroneously denied emergency authorizations (Type II errors), by contrast, are less likely to later be found safe and effective. To be clear, public trust is not the only consideration in balancing Type I versus Type II errors, so this does not mean that Type I errors are more problematic overall. But the asymmetric effect on public trust is one factor that regulators should consider when balancing the fundamental tradeoff between risk and access.

Third, U.S. agencies could combat some of the uncertainty and public trust issues faced at home by learning from and relying on their international counterparts—not only in terms of shifting domestic recommendations based on internationally derived evidence, but also the administrative processes for withdrawals. France’s Ministry for Solidarity and Health, for example, barred the use of HCQ in May after particularly negative evidence about the drug began to roll in—weeks before FDA revoked its EUA of the same. Understanding not just the evidentiary basis for these decisions but how, mechanically, they were made may help U.S. agencies make swifter, better-informed decisions.

Of course, each of these suggestions is based on our assumptions of how the public will respond to certain agency actions, and public reaction to scientific information can be counterintuitive. In some contexts, efforts to improve public education about technical information can increase polarization about scientific facts. The idea that public trust will be enhanced by more explicit communication about uncertainty in FDA decisions should thus be treated as a plausible but testable hypothesis—and moving forward (including for the next pandemic), health regulators should fund and pay attention to research on the science of science communication in this context.

In the end, agencies’ “reputation and power” comes down to not just resolving uncertainty but also garnering public trust in the process. Correct scientific decisions from agencies that no one trusts are unlikely to change social behavior to stop a pandemic. This is ever more true for COVID-19. Getting things “right” the first time, 100% of the time, just isn’t feasible. What agencies and policymakers should strive for, especially in the face of significant scientific uncertainty, is to do what they hope to do best: to be transparent that their decisions must evolve with the underlying scientific landscape.

This post is part of a weekly series on COVID-19 innovation law and policy. Author order is rotated each week.

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Saturday, 20 June 2020

Togaf - Konsep Inti - Arsitektur Repository

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Togaf - Konsep Inti - Arsitektur Capabilities



OK, sekarang kita turun ke konsep terakhir, yaitu konsep inti, yang merupakan kemampuan arsitektur organisasi Anda. Jadi, apa itu kemampuan arsitektur? Sekarang, jelas bahwa fungsi arsitektur mendukung bisnis. Dibutuhkan tujuan bisnis dan desain aplikasi, data, dan teknologi untuk memenuhi tujuan tersebut. Seberapa baik perusahaan Anda dalam hal ini? Apakah Anda memiliki orang yang menjadi arsitek penuh waktu atau hanya peran paruh waktu? Apakah ada kelompok arsitek? Bagaimana dengan manajer grup ini? Apakah mereka berkomitmen pada arsitektur? Apakah ada dewan tata kelola? Apakah Anda mengikuti semua proses dan prosedur yang tercantum dalam TOGAF?

Jadi, jelas Anda dapat menilai diri sendiri pada skala 1 hingga 10 seberapa baik Anda dalam arsitektur. Mungkin 1 jika Anda baru memulai, baru saja menyewa arsitek pertama Anda, dan tidak ada yang benar-benar tahu apa yang mereka lakukan. Ini seperti eksperimen. Anda baru memulai, tingkat dasar satu. Tetapi kemudian Anda bisa bekerja hingga sembilan atau sepuluh di mana tata kelola arsitektur kuat dan Anda memiliki grup yang mendukungnya. Semua orang tahu apa yang mereka lakukan, dan Anda menembaki semua silinder. Itu semacam skala penilaian.

Pertanyaan lainnya adalah apakah perusahaan Anda mendukung arsitektur ini? Apakah CEO dan tim eksekutif menghormati keputusan arsitektur? Dan bagaimana jika Anda mencoba mengembangkan arsitektur, tetapi kepala Departemen IT mengatakan "tidak, kita tidak akan melakukannya"? Atau implementasi grup mengatakan "kami tidak berpikir perlu melakukan A, B, dan C. Kami hanya akan melakukan D, E, dan F." Begitu Anda menghadapi masalah, bagaimana itu bisa diselesaikan? Apa saja peran dan tanggung jawab yang berbeda? Kami memiliki arsitek bisnis, arsitek data, arsitek teknis, dan dewan tata kelola memiliki peran masing-masing. Jadi, semua orang memiliki peran untuk dimainkan, dan keahlian Anda sebagai arsitek sangat penting. Seberapa terlatih Anda, seberapa baik Anda dalam pekerjaan ini, termasuk templat dan proses yang Anda miliki di tempat.

Jadi begitu, itulah konsep inti dari TOGAF. Semoga itu masuk akal bagi Anda. Seperti yang saya katakan, banyak dari ini tercakup di tempat lain dalam kursus, jadi jangan merasa seperti Anda tidak mengerti sesuatu yang "itu saja." Anda mandek. Jangan ragu untuk melanjutkan. Pergi ke sana dan lihat video. Dan masuk lebih dalam ke dalamnya. Silakan baca spesifikasi TOGAF. Bagian 1 mencakup banyak hal ini. Dan semoga setelah menonton video ini, semuanya menjadi lebih mudah untuk Anda lakukan. Selanjutnya, setelah kita menjelaskan konsep dasar TOGAF, sekarang waktunya untuk kuis. Jadi, tetap tunggu untuk itu.

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Togaf - Konsep Inti - Enterprise Continium

Dalam pelajaran ini, kita sedang membahas Enterprise Continuum, yang merupakan salah satu konsep inti dari TOGAF 9.1 spec. Jadi, apa itu Continuum Perusahaan? Kata "Continuum" sebenarnya tidak memberi tahu Anda secara langsung apa artinya. Secara umum, kontinum dalam hal ini mengacu pada garis atau spektrum, dan Anda dapat memetakan arsitektur Anda di sepanjang garis ini. Untuk arsitektur perusahaan yang lebih spesifik, itu akan berada di sebelah kanan garis, tetapi semakin generik, akan dipetakan ke kiri.

Ide dasarnya adalah bahwa Anda dapat mencari solusi umum yang ada untuk industri Anda atau untuk bisnis secara umum. Anda dapat mengambil solusi generik dari organisasi lain, membawanya ke perusahaan Anda, dan menggunakannya untuk membuat arsitektur Anda. Ini sebenarnya hanya cara untuk melihat Repositori Arsitektur, bukan sesuatu yang terpisah. Ini adalah cara mengklasifikasikan item dalam repositori arsitektur Anda menjadi sangat generik, sistem, atau pondasi khusus industri atau umum di sebelah kiri, dengan yang paling generik di sebelah kiri dan yang paling spesifik di sebelah kanan.

Ada empat klasifikasi dalam Enterprise Continuum dalam TOGAF:

Arsitektur Pondasi: Ini adalah klasifikasi yang paling umum. Contohnya adalah TRM (Technical Reference Model), yang sangat umum dan dapat diterapkan pada berbagai situasi perusahaan.

Arsitektur Sistem Umum: Ini adalah layer yang sedikit lebih spesifik daripada arsitektur pondasi. Contohnya adalah III-RM (Integrated Information Infrastructure Reference Model), yang merupakan model layanan perangkat lunak dalam TOGAF. Meskipun lebih spesifik, masih berlaku untuk banyak situasi.

Arsitektur Industri: Klasifikasi ini lebih spesifik untuk industri tertentu. Contohnya, jika Anda berada di industri perbankan, Anda dapat mengambil arsitektur industri dari industri perbankan atau dari industri lain yang sesuai.

Arsitektur Spesifik Organisasi: Ini adalah klasifikasi yang paling spesifik, berada di sisi kanan kontinum. Ini mencakup arsitektur yang dikembangkan khusus untuk organisasi tertentu.

Ada video lain dalam kursus ini yang lebih mendalam tentang Enterprise Continuum, dengan diagram lebih lanjut. Saya sarankan untuk melihatnya jika Anda ingin memahami konsep ini lebih rinci. Ini adalah salah satu konsep inti dari TOGAF yang membutuhkan sedikit waktu untuk benar-benar dipahami.

Selanjutnya, kita akan membahas hal-hal yang sedang diklasifikasikan, yaitu isi dari repositori arsitektur. Jadi, tetaplah di sini untuk itu.

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Togaf - Konsep Inti - Pengiriman


Dalam pelajaran ini, kita akan membahas kiriman, artefak, dan blok bangunan, yang merupakan konsep inti lainnya dari spesifikasi TOGAF. Saat Anda menjalani siklus ADM (Architecture Development Method) dan mulai membuat dokumen, ini menjadi kiriman. Hasil kerja ini "ditentukan secara kontrak, ditinjau, disepakati ke dan ditandatangani oleh para pemangku kepentingan." Ketika Anda membuat peta jalan, persyaratan, definisi, atau rencana implementasi, Anda secara kontraktual berkewajiban untuk membuat dokumen-dokumen ini, dan mereka menjadi keluaran dan hasil dari proses tersebut.

Artefak, di sisi lain, adalah produk karya arsitektur. Ini berarti saat Anda membuat output ini, Anda bisa membuat diagram, daftar, matriks, atau bahkan hanya mencatat informasi pemangku kepentingan seperti judul, alamat email, dan informasi kontak mereka. Artefak ini mungkin tidak selalu dimasukkan ke dalam dokumen aktual, tetapi Anda membuatnya karena membutuhkan daftar pemangku kepentingan atau informasi yang masuk ke dalam repositori arsitektur, yang akan kita bahas lebih lanjut.

Blok Bangunan adalah elemen penting yang mungkin tidak dibahas secara rinci dalam TOGAF, tetapi Anda harus memahami bahwa arsitektur terdiri dari blok bangunan. Ketika Anda menyatakan bahwa Anda membutuhkan sistem entri pesanan, Anda sebenarnya tidak merancang sistem tersebut secara spesifik. Anda hanya memberikan pandangan tingkat tinggi, menggambarkan bahwa kita membutuhkan sistem entri pesanan yang dapat menerima, mengubah, menghapus, dan mengarsipkan pesanan. Sistem entri pesanan menjadi blok bangunan dalam konteks ini.

Blok Bangunan Arsitektur adalah seperti persyaratan, seperti contoh sistem entri pesanan. Hal ini disebut ABB (Architectural Building Block). Blok Bangunan Solusi, di sisi lain, adalah implementasi aktual dari ABB tersebut. Jika Anda memiliki sistem entri pesanan yang dapat digunakan dalam berbagai skenario, itu menjadi Blok Bangunan Solusi. Ada hubungan antara Blok Bangunan Arsitektur dan Blok Bangunan Solusi, dan keduanya berada di bawah kategori Blok Bangunan.

Kita akan membahas bagaimana Blok Bangunan ini dapat diabstraksikan. Mereka bisa sangat spesifik, seperti sistem entri pesanan, atau sangat umum. Blok-blok bangunan ditempatkan di dalam kontinum perusahaan, yang akan kita bahas lebih lanjut dalam pembahasan selanjutnya.

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Togaf - Konsep inti ADM

Baik, mari kita bahas konsep inti selanjutnya, yaitu Metode Pengembangan Arsitektur (ADM) yang merupakan inti dari TOGAF. ADM adalah proses utama di TOGAF, di mana arsitektur dirancang. Ini adalah pendekatan langkah demi langkah untuk mendefinisikan arsitektur, mengimplementasikannya, dan memantau perubahan. ADM terdiri dari sembilan fase, seperti yang dapat Anda lihat dalam lingkaran kuning di layar, dengan manajemen persyaratan duduk di tengah lingkaran oranye. Ini adalah proses berulang, di mana setelah selesai satu siklus, Anda dapat mulai lagi.

Ada dua tipe dasar arsitektur yang difokuskan dalam ADM: arsitektur dasar dan arsitektur target. Arsitektur dasar adalah keadaan sistem saat ini, sedangkan arsitektur target adalah arsitektur yang diinginkan. Pendekatan dasar seringkali untuk keluar dan mendokumentasikan apa yang Anda miliki saat ini. Arsitektur target muncul setelah Anda menemukan apa yang Anda butuhkan dan membuat keputusan perubahan.

Arsitektur transisi adalah langkah di antara arsitektur dasar dan arsitektur target. Ini adalah rencana untuk mencapai arsitektur target dengan melakukan perubahan bertahap. Sebagai contoh, Anda mungkin memiliki banyak sistem yang perlu diubah, dan arsitektur transisi membantu Anda merencanakan perubahan dalam jangka waktu tertentu.

ADM memiliki fokus langkah demi langkah, tetapi kita hanya menyentuhnya secara singkat di sini. Selanjutnya, kita akan membahas output dari setiap fase ADM, yang dikenal sebagai kiriman, artefak, dan blok bangunan. Tetaplah di sini untuk informasi lebih lanjut.


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Togaf : Arsitektur Domain

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Togaf : Dasar dan Konsep Inti Togaf

Pemahaman tentang Konsep Dasar dan Inti dari TOGAF merupakan langkah awal yang penting dalam menerapkan kerangka kerja arsitektur ini. TOGAF memiliki tiga elemen kunci yang membentuk landasan dasar:

Definisi Definisi: Ini mencakup definisi yang jelas tentang mengapa perusahaan perlu memiliki arsitektur dan apa manfaatnya. Menjelaskan tujuan dan ruang lingkup arsitektur organisasi adalah langkah awal untuk memahami pentingnya pengembangan arsitektur.

Proses Pembuatan dan Pengelolaan Arsitektur: TOGAF menyediakan proses yang terstruktur untuk menciptakan dan mengelola arsitektur perusahaan. Proses ini dikenal sebagai ADM (Metode Pengembangan Arsitektur) dan membimbing para arsitek melalui langkah-langkah yang terorganisir untuk menghasilkan arsitektur yang efektif.

Metamodel Konten: Ini adalah kerangka kerja yang memungkinkan penyimpanan konten arsitektur. Dengan metamodel konten, TOGAF memberikan cara untuk mengorganisir dan menyimpan informasi arsitektur sehingga dapat diakses dan digunakan dengan efisien.

Dalam bagian ini dari kursus, akan dibahas Konsep Dasar dan Inti dari TOGAF. Ini melibatkan pemahaman mengapa perusahaan perlu mendefinisikan arsitektur, apa itu arsitektur, apa kerangka arsitektur, konsep domain arsitektur (BDAT), dan bagaimana ADM menjadi elemen kunci dalam TOGAF.

Dalam dua pelajaran berikutnya, kita akan menjelajahi lebih dalam tentang konsep dasar dan inti TOGAF, yang akan memberikan landasan yang kuat untuk memahami dan mengimplementasikan kerangka kerja arsitektur ini.

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Togaf - Pengantar Enterprise arsitektur

TOGAF, atau The Open Group Architecture Framework, adalah kerangka kerja arsitektur dan standar terkemuka yang digunakan untuk mengembangkan dan mengelola arsitektur enterprise. Dengan fokus pada perencanaan strategis dan implementasi arsitektur IT, TOGAF membantu organisasi merancang dan mengelola perubahan arsitektur mereka.

Pengantar Informal TOGAF:
1. Definisi:

TOGAF adalah kerangka kerja arsitektur yang menetapkan kondisi masa depan yang diinginkan untuk suatu perusahaan.
Menggunakan proses Arsitektur Metode Pengembangan (ADM) sebagai inti dari implementasinya.
2. ADM (Metode Pengembangan Arsitektur):

ADM adalah proses terpusat dalam TOGAF yang membimbing para arsitek melalui langkah-langkah untuk mendefinisikan dan mengimplementasikan arsitektur perusahaan.
Terdiri dari sembilan fase, ADM memberikan pendekatan sistematis untuk mencapai arsitektur target.
3. Tujuan Utama:

TOGAF membantu merinci keadaan masa depan yang diinginkan dan langkah-langkah yang diperlukan untuk mencapainya dari situasi saat ini.
Mendefinisikan arsitektur target melalui proses ADM.
4. Manfaat Perusahaan:

TOGAF membantu menghubungkan strategi jangka panjang perusahaan dengan rencana operasional yang dapat diimplementasikan secara merata di seluruh organisasi.
Memberikan struktur dan rencana yang diperlukan untuk mengarahkan perubahan arsitektur secara efisien.
5. Contoh Kasus:

Misalnya, TOGAF dapat digunakan ketika dewan direksi memutuskan untuk memindahkan layanan perusahaan ke platform online.
ADM membantu merancang rencana bertahap untuk mengimplementasikan perubahan tersebut.
6. Arsitektur Domain (BDAT):

Empat domain arsitektur utama: Bisnis, Data, Aplikasi, dan Teknologi.
ADM memperlakukan masing-masing sebagai fase terpisah, dengan urutan yang ditentukan.
7. Mengapa Perusahaan Membutuhkan Arsitektur:

Fungsi arsitektur menghubungkan strategi perusahaan dengan rencana yang dapat diimplementasikan.
Arsitektur membantu organisasi beradaptasi dengan perubahan melalui pemahaman dan perencanaan yang sistematis.
8. Kesimpulan:

TOGAF berfungsi sebagai panduan dan standar untuk pengembangan arsitektur enterprise.
ADM adalah inti dari TOGAF, membantu organisasi mengarahkan perubahan dan mencapai arsitektur target.
TOGAF memberikan struktur dan proses yang diperlukan untuk mengelola dan mengembangkan arsitektur enterprise dengan cara yang terorganisir dan efektif. Implementasi TOGAF membantu organisasi bergerak seiring perubahan dinamis dalam lingkungan bisnis.

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Thursday, 18 June 2020

How can the government improve access to COVID-19 preventatives and treatments for low-income Americans?


In the United States, one of the most important factors in receiving COVID-19 testing or treatment is access to insurance. But insurance—like other health innovations—is grossly and unevenly distributed. In particular, because of the way income and employment are distributed in the U.S.—and the country’s long-standing connection between income, employment, and insurance—Black Americans and other people of color remain vastly uninsured or underinsured, problems likely to be exacerbated by the COVID-19 pandemic. In this post, we look at how insurance policy—itself, a form of health innovation policy—has a racially disparate effect in the pandemic, with a particular focus on Medicaid.

Who is covered by Medicaid during the pandemic?

Medicaid is a classic cooperative federalism program, with the states and the federal government jointly in charge of its administration. When first created in 1965, Medicaid was conceived of as providing health insurance and health care to specific low-income populations, including children, pregnant women, the elderly, and disabled individuals. In 2010, the Affordable Care Act sought to expand Medicaid to all Americans earning below 138% of the federal poverty level (in 2020, $17,608 for an individual, and $36,156 for a family of four). The Supreme Court, however, held in 2012 that this expansion was optional for states. At present, 37 states (including DC) have chosen to adopt the expansion. Medicaid enrollment in expansion states has grown by 12.4 million since the expansion began, but millions of otherwise eligible Americans remain uninsured, particularly as populous states like Florida and Texas have declined to opt in to the expansion.

States’ decisions not to expand Medicaid disproportionately disadvantage minorities, and particularly Black Americans. The Kaiser Family Foundation (KFF) has calculated that uninsured Black adults “are more than twice as likely as White and Hispanic uninsured adults” to lack insurance due to a failure to expand Medicaid. These disparities are likely to grow as a result of the COVID-19 pandemic, in which the unemployment rate for Black Americans continues to rise even as the unemployment rate for whites falls. Because health insurance in America is typically tied to employment status, the disparity in unemployment rates will likely exacerbate disparities in health insurance status and access to care.

What COVID-19 costs does Medicaid cover?

Given the financial situation of most Medicaid enrollees, cost-sharing obligations for beneficiaries (in terms of premiums, deductibles, copayments, etc.) are tightly constrained by law and are prohibited in many cases. The March 18 Families First Coronavirus Response Act (FFCRA) went further, requiring Medicaid (among other insurers, including Medicare) to cover the costs of COVID-19 testing and associated services with no cost-sharing to beneficiaries. Beneficiaries thus can expect that any COVID-19 testing and treatment costs would be covered fully by Medicaid, as essential benefits under the program.

But in other ways, the federal government’s decisions about Medicaid funding during the pandemic have continued to disadvantage minority populations, particularly Black Americans. In the March 25 Coronavirus Aid, Relief, and Economic Security (CARES) Act and April 24 Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA), Congress appropriated a combined $175 billion to be disbursed to healthcare providers, who faced precipitous revenue drops due to pauses in non-emergency services. The federal government, which has sole oversight over the Medicare program, quickly disbursed $50 billion of this pool to providers serving a large number of Medicare beneficiaries. But it took the federal government ten weeks to award any funds to entities serving large numbers of Medicaid beneficiaries, only doing so after bipartisan pressure from legislators. This delay in disbursing funding has specifically exacerbated racial health disparities: as of early May, nearly 2,000 community health centers, which disproportionately serve low-income communities and people of color, have closed, at least temporarily, due to COVID-19.

The consequences of these payment delays were foreseen and avoidable. In early April, the National Association of Medicaid Directors asked the Centers for Medicare and Medicaid Services (CMS) to allow states to make emergency retainer payments to essential Medicaid providers. CMS did not permit states to do so, stating that it could not disburse funding to the states under the terms of the law. As the Washington Post reports, this decision was not universally agreed upon, and CMS’s broad statutory authority to allow states to experiment with the financing of the Medicaid program would seem to allow states to distribute funding themselves.

Who remains uninsured in America?

Even taking into account employer-sponsored insurance plans and the ACA’s expansion of Medicaid, a startling number of Americans still lack health insurance: approximately 30 million Americans in 2019. Among working-age adults, the uninsured are disproportionately low-income, Latinx, and under age 35; and the main concern cited for not obtaining insurance was affordability. As of May 2, KFF estimated that around 27 million more Americans could lose employer-sponsored health insurance due to COVID-19-related job loss, leaving them struggling to determine whether they are eligible for publicly subsidized coverage.

Policymakers have a number of options for helping more Americans gain healthcare coverage. State legislators could choose to expand Medicaid eligibility in the 14 states that have failed to do so, and the federal government could reopen the Affordable Care Act’s insurance exchanges to permit new signups by those who have lost their coverage. Sadly, neither option, at least as of this writing, seems to be a legislative priority. In the shorter term, the federal government has stepped in to limit out-of-pocket costs for uninsured patients during the pandemic. But how long and how significant this temporary relief will last is unclear.

What COVID-19 tests and treatments is the government covering for the uninsured?

In contrast to expanding insurance programs to insure lower-income COVID-19 patients, the federal government has been active in expanding insurance coverage to include a greater number of COVID-19 tests and treatments. The FFCRA requires insurers to cover COVID-19 testing costs with no patient contribution, allocating $1 billion to reimburse providers for COVID-19 testing of uninsured patients. And in April, Health and Human Services Secretary Alex Azar stated that HHS would use some of the $175 billion allocated under the CARES Act and the and PPPHCEA to compensate providers of uninsured COVID-19 patients “at the Medicare reimbursement rates,” and that they would be “not allowed to bill that uninsured individual anything.” To implement this commitment, HHS launched a COVID-19 Uninsured Program Portal on April 27 for providers to file reimbursement claims for COVID-19 testing or treatment for uninsured patients, including undocumented immigrants. The program also includes coverage of an FDA-approved vaccine, when available.

This program is an important step toward improving access to COVID-19 care for some of the most vulnerable Americans, but it is not a substitute for more systemic reform for at least three reasons. First, due to administrative difficulties, take-up of this benefit has been slow and limited so far. As of June 12, only $130 million has been paid through this program, and it is unclear how many uninsured patients have been billed for their care—often at undiscounted prices—because providers were unaware of this program or chose not to participate. Second, even if take-up improves, reimbursement for uninsured COVID-19 patients is “subject to available funding,” and as KFF reported Tuesday, it is unclear how much funding will be available. $112 billion of the original $175 billion has been allocated already for other purposes, and none of the remaining $63 billion has been specifically earmarked for uninsured patients. HHS has not indicated how it will balance competing needs when distributing these limited funds. Finally, reimbursement for treatment requires a primary COVID-19 diagnosis; it will not aid the uninsured who need care for other conditions, even if they also have COVID-19.

What about low-income but insured patients?

Even when patients have insurance, and even though federal law mandates that most insurers cover costs relating to testing and treatment for COVID-19, many costs fall through the cracks such that patients still may face substantial financial burdens. Much like the rest of the American health-care system, reimbursement is often a fragmented mess. The various payments patients still have to make, even when insured, are numerous—deductibles, co-pays, and co-insurance—and each has its own rules and limits.

On the testing side, insured patients may still face large out-of-pocket costs for at least three reasons. First, the FFRCA’s free COVID-19 testing coverage requirement only kicks in if a COVID-19 test is actually ordered. Because tests were extremely hard to come by in the initial stages of the pandemic—and are still challenging to get in some locations—this may still pose a problem. Some patients who have complained of COVID-19 symptoms have had their provider order other tests, for flu or other ailments to rule those out, especially if COVID-19 tests are scarce. But these tests aren’t directly covered under the FFRCA, meaning patients have been billed for them.

Second, in 2018, the Trump administration eased restrictions on short-term insurance policies, which are generally cheaper to insureds but provide less coverage than regular insurance policies. Currently, those policies are not covered under the FFRCA, and are therefore not required to cover COVID-19 testing cost-free. One last restriction has to do with timing; cost-free testing or treatment only applies for tests or treatment on or after March 18, 2020. But by that time, over 6,000 people had already tested positive for SARS-CoV-2.

Finally, there is still uncertainty about who is going to cover some tests, especially tests for workers who need testing to go back to work. Employees of nursing homes in New York must be tested weekly, but it’s still uncertain—six months after the first coronavirus case was reported in the United States—as to whether the nursing home, the employee’s insurer, or the state is picking up the tab. Shockingly, some insurers have refused to cover the test as a non-reimbursable workplace expense. Given that nursing home workers are disproportionately women of color, this morass places an even greater burden on them, even when they are insured.

The treatment side is even more complex. There’s no uniform federal policy on reimbursement for COVID-19 treatment, so it’s been left up to insurers and the states. Most major plans have waived patient contributions, but not all. Some states have said relatively little; other states have been generous, requiring insurers to cover treatment costs without patient contributions (though those ERISA buffs among you will correctly note that self-insured plans aren’t covered by these rules). In states without such strictures, patients may still be responsible for co-pays, deductibles, co-insurance, and potentially balance billing from providers who say the patient’s insurance didn’t cover the full cost. Given the lack of authorized COVID-19 treatments aside from remdesivir, patients receiving experimental treatment may also find their insurers balking at coverage. (Remdesivir itself is still free, for now, as available supplies have been donated by Gilead.)

Finally, the complex systems of insurance reimbursement leave plenty of room for mistakes. Even though federal law requires that insurers cover bills sent directly to patients from out-of-network providers for testing, insurers don’t always catch that, and patients can see bills as a result. Despite concerted federal action and fragmented state action, those with insurance can find themselves facing the unexpected bill for hundreds of thousands of dollars—even if they did everything right.

The most straightforward action that government could take in response to these coverage gaps would be to follow the lead of some states, and require COVID-19 treatments to be covered by insurers without patient contributions. COVID-19-related testing should also be covered, whether or not an actual COVID-19 test is performed, if a patient presents with COVID-19 symptoms. The reasoning is simple: it’s bad policy to have symptomatic patients with scant insurance avoid getting testing in the fear that their provider will test them for other ailments. This should be easier as more tests become more available—a different innovation policy lever. The goal of these policies is not only to decrease the financial burdens of care and the resulting inequitable hardship for Black Americans and other vulnerable communities—even though that would be a significant and important salutary effect. Such policies should also reduce the financial fears of the underinsured more broadly, making it easier for all Americans to get tested and treated—a key policy goal for tamping down the pandemic.

This post is part of a weekly series on COVID-19 innovation law and policy. Author order is rotated each week.

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